NRS Stroke Research Network Research Study Summaries
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ACUTE research is when a patient admitted to hospital having had a stroke is asked to take
part in research that might involve a new stroke treatment.
ARTSS2
ECASS 4 Extend
ENCHANTED
EuroHYP-1
FOCUS
GOLD 2.2
LINCHPIN
MICA
PATCH
PISTE
RTEASE
TARDIS
TITCH 2
WAKE-UP
PREVENTION research increases understanding of what causes a stroke to happen and
improves the prevention of stroke in routine clinical practice – using a broad range of
research techniques.
CROMIS2
CVR Lacunar Stroke Study v1.0
ECST-2
Gluteal biopsy in CADASIL
RESTART
XILO-FIST - NEW
-1-
REHABILITATION stroke studies aim to restore functional recovery and to facilitate patients
and their carers to lead the lives they wish.
ACCESS
BIG CACTUS
EVERLAP – NEW
Examining a 'life after stroke' help sheet for stroke survivors – NEW
Long term consequences and recovery from stroke: what is important to stroke survivors
and health professionals?
MELLO
NON INVASIVE BRAIN STIMULATION IN STROKE PATIENTS - NEW
OSPREy
RATULS
TEARS
TREAT UI
SOCLE II
-2-
ACUTE STUDIES
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Study Title
ARTSS2
A pilot, phase IIb, randomised, multi-center trial of
Argatroban in combination with recombinant tissue
plasminogen activator for acute stroke
Study Type
Acute
Lay Summary
A pilot, phase IIb, randomised, multicentre trial of
Argatroban in combination with recombinant tissue
plasminogen activator for acute stroke. Recombinant
tissue plasminogen activator (rtPA), the only proven
treatment for acute ischemic stroke, fails to reperfuse the
brain in most patients with large thrombi. In a Phase IIa
lowdose safety study (n=65), conducted by University of
TexasHouston, delivering Argatroban with rtPA indicated
that both drugs appear safe when delivered concomitantly
and recanalisation rates were greater than with historical
controls. The purpose of the trial is to estimate the overall
treatment benefit (improvement in disability) among
stroke patients treated with rtPA (Alteplase) who are
randomised to receive either lowdose Argatroban,
highdose Argatroban or neither. This study will provide
evidencebased hypotheses and data needed to design a
larger definitive trial. The study will be conducted in six
hospitals across the UK and will recruit males and females
over 18 years of age with acute ischemic stroke. During
the course of the treatment, patients will be evaluated via
CT angiogram, CT scans, vital signs, laboratory
measurements, and neurological and unctional outcomes.
Patients will also be evaluated at 24 hours following the
onset of the stroke, Day 7 or discharge (whichever comes
first) and at day 90.
Funding Body
NIH USA
-3-
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Study Title
ECASS 4 Extend
European Cooperative Acute Stroke Study4: Extending
the time for Thrombolysis in Emergency Neurological
Deficits
Study Type
Acute
Lay Summary
The aim of this study is to assess the safety and
effectiveness of a drug called Alteplase in patients who
have suffered an ischaemic stroke. At the moment the
approved window following a stroke for Alteplase to be
administered is three hours. This is a short period and so
this study is looking at extending that time and establish
efficacy at 4.5 to 9 hours following onset, or following the
patient waking up with with symptoms of a stroke (wake
up stroke).
Funding Body
Boehringer Ingelheim Ltd
-4-
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Study Title
ENCHANTED
An international randomised controlled trial to establish
the effects of low–dose rtPA and the effects of early
intensive blood pressure lowering in patients with acute
ischaemic stroke
Study Type
Acute
Lay Summary
ENCHANTED is an independent, investigator initiated,
international collaborative, quasi-factorial randomised
controlled trial involving a package of 2 linked
comparative randomised treatment arms, which aims to
address 4 key questions in patients eligible for
thrombolysis in the acute phase of ischaemic stroke. (1)
Does low-dose (0.6 mg/kg) intravenous (i.v.)
recombinant tissue plasminogen activator (rtPA) provide
equivalent benefits compared to standard-dose (0.9
mg/kg) rtPA? (2) Does intensive blood pressure (BP)
lowering (140-150 mmHg systolic target) improve
outcomes compared to the current guideline
recommended level of BP control (180 mmHg systolic
target)? (3) Does low-dose (0.6 mg/kg) intravenous (i.v.)
recombinant tissue plasminogen activator (rtPA) reduce
the risk of symptomatic intracerebral haemorrhage
(sICH)? (4) Does the addition of intensive BP lowering to
thrombolysis with rtPA reduce the risk of symptomatic
intracerebral haemorrhage (sICH)?
Funding Body
Australian National Health and Medical Research Council
-5-
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Study Title
EuroHYP-1
European multicentre, randomised, phase III clinical trial
of therapeutic hypothermia plus best medical treatment
versus best medical treatment alone for acute ischaemic
stroke
Study Type
Acute
Lay Summary
Stroke is the second cause of death world-wide and the
second cause of lost disability-adjusted life years in highincome countries. Because stroke incidence rises
exponentially with age, the social and economic burden of
stroke will rise further with the ageing of the population.
The large majority of strokes (about 80%) are caused by
arterial or arteriolar occlusion. Treatment options for
these ischaemic strokes are extremely limited.
The aim of this study is to determine whether systemic
cooling to a target temperature of 34 to 35°C, started
within 6 hours of symptom onset and maintained for 24
hours, improves functional outcome at 3 months in
patients with acute ischaemic stroke.
Funding Body
EU- FP7
-6-
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Study Title
Study Type
Lay Summary
Funding Body
FOCUS
The effect (s) of routine administration of Fluoxetine in
patients with a recent stroke
Acute
A stroke is caused by sudden blockage or bursting of an
artery in the brain. Stroke is the most common cause of
adult disability in the UK. New treatments are needed to
reduce the burden of disability caused by stroke.
Fluoxetine is an effective and safe drug which has been
successfully used for many years to relieve depression.
Recent research has suggested that it also has other
effects on the brain that may help patients make a better
recovery from the physical effects of their stroke e.g.
development of new brain cells (neurogenesis). For
example, a recent small trial from France (the FLAME
trial) suggested that fluoxetine might improve the
recovery of strength in stroke survivors with residual arm
weakness. These promising results now need to be
confirmed by a definitive trial recruiting a much larger
number of patients. The overall aim of our research is to
find out whether fluoxetine improves recovery if given to
stroke survivors who are between 2 and 15 days after the
onset of their stroke, and who still have residual problems
such as a weak arm, weak leg or language problems. We
will also find out whether it helps the stroke survivor
overcome weakness, communication difficulties or fatigue.
We will do this by performing a large randomised trial in
the UK, recruiting approximately 3000 patients. Half the
patients will be randomly allocated fluoxetine for 6
months, and the other half will receive a placebo pill. For
patients who cannot swallow, we will give the drug or a
matching placebo through their feeding tube. Patients will
be followed up at 6 months, and then at 12 months, to
see whether any benefits persist long-term.
Stroke Association
-7-
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Study Title
GOLD 2.2
Gold 2.2: Metabolic MRI in Acute Stroke; Development
and Vaildation of the 'Oxygen Challenge' Technique
Study Type
Acute
Lay Summary
Most strokes are caused by a blood clot that blocks a blood vessel
to the brain. Some patients with this type of stroke can be given
treatment with'clotbusting' drugs. This treatment considerably
improves the chances of a good outcome from stroke, if given
within 4.5 hours of onset. However there is a small risk (affecting 1
person in 50) of causing serious bleeding within the brain. The risk
might be reduced by use of advanced brain scanning. Identifying
those patients most likely to benefit from treatment and avoiding
treatment in those in whom it is both unlikely to be helpful and high
risk. We have developed a brain scanning technique that may
improve on existing imaging methods for evaluation of patients
with acute stroke by giving information on how brain tissue
responds to extra oxygen. This involves administration of
additional oxygen using a face mask for a few minutes ("Oxygen
Challenge") during a standard Magnetic Reasonance Imaging
(MRI) scan. By analysing the response of a particular MRI signal
to the extra oxygen, we can map areas of the brain that are under
stress (for example by having acutely reduced blood supply such
as happens in stroke). Pilot clinical studies support the potential for
this novel technique to identify patients most likely to benefit from
the treatment (Dani et al, Ann Neurol 2010: 68; 3747). Further
work is necessary to validate and refine this work. We wish to
investigate whether the MRI signal change is affected by blood
flow. In order to do this, we will scan people with a stable
narrowing of one of the major blood vesssles that supply the brain
(carotid ararteries).
Chief Scientist Office (CSO) of the Scottish Government Health
Directorates
Funding Body
-8-
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Study Title
Study Type
Lay Summary
Funding Body
LINCHPIN
Lothian study of INtraCerebral Haemorrhage Pathology,
Imaging and Neurological outcome (LINCHPIN)
Acute
About one in six strokes are due to bleeding into the
brain. 15,000 adults in the UK suffer such a bleed
annually and the effects can be devastating. 40% of
patients die within the first month and those that survive
can be functionally impaired.
We seek to understand more about a cause of brain
haemorrhage called cerebral amyloid angiopathy (CAA).
CAA is the deposition of an abnormal protein called
amyloid in the blood vessels of the brain. Clinicians
frequently assume that CAA causes bleeds which occur
near the surface of the brain, whereas other conditions
(such as high blood pressure) cause bleeding deep within
the brain. However, when we reviewed the literature in
this area, there were only four relevant studies and the
evidence for a link between CAA and bleeding near the
surface of the brain is inconclusive. In addition, CAA can
only be diagnosed with certainty on pathological
examination (brain biopsy or post mortem). This project
tests these assumptions and also aims to see if brain
imaging can help detect CAA. In the future, this might
help to detect and treat CAA before a bleed occurs.
Over a two year period, we will prospectively recruit
patients, aged 16 years or more, who are admitted to
hospitals in the Lothian region or who die suddenly in the
community as a result of spontaneous bleeds into the
brain. Some patients will have a magnetic resonance
imaging brain scan within one month of the bleed and we
will compare imaging and brain tissue samples of people
who have died from bleeds with people who have died
from other causes. We hope this work will help doctors to
develop a more rational and effective approach to
managing this potentially devastating condition.
Medical Research Council (MRC)
-9-
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Study Title
Study Type
Lay Summary
Funding Body
MICA
Metabolic Imaging in Carotid Atherosclerosis
Acute
Hardening of the arteries (atherosclerosis) is a common
disorder that causes heart attacks and strokes. PET CT
and contrast-enhanced MRI scans are two new ways of
assessing atherosclerosis. We propose to do PET CT and
MRI scans on patients with hardening of the neck arteries
due to undergo surgery to remove the hardened areas.
We will then be able to compare the hot spots found on
these scans with what we can see in the removed
specimens under the microscope in the laboratory. This
will give us insight into the value of PET CT and MRI as
tools for assessing atherosclerosis. It will also provide us
with new information relating to the underlying processes
that give rise to atherosclerosis and will pave the way for
the future development of new treatments.
British Heart Foundation (BHF)
- 10 -
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Study Title
Study Type
PATCH
Platelet Transfusion in Cerebral Haemorrhage
Acute
Lay Summary
More than one tenth of all strokes are caused by
intracerebral haemorrhage (ICH). The bigger the ICH, the
more likely it is to be fatal. People taking antiplatelet
agents that affect clotting by acting on platelets (e.g.
aspirin) appear more likely to die if they have an ICH.
Therefore, this clinical trial aims to establish whether a
transfusion of platelets given within 6 hours of ICH onset
can reduce the risk of deathor disability in adults who had
been taking antiplatelet drugs for at leastone week before
the ICH.
Funding Body
Chest, Heart and Stroke Scotland
- 11 -
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Study Title
PISTE
Pragmatic Ischaemic Stroke Thrombectomy Evaluation
Study Type
Acute
Lay Summary
Most strokes are caused by blockage in an artery in the
brain caused by a blood clot, resulting in death of brain
tissue that is starved of blood supply. Very early use of
clotbusting (thrombolytic) drugs can restore the blood
supply and limit the damage, resulting in an increased
proportion of people making a recovery to independence
after stroke. However, these drugs only succeed in
restoring blood flow in a minority of people with clots in
the larger arteries (10-25% depending on the size of the
blood vessel) and these people also have the most severe
strokes and highest risk of death or dependence as a
result of the stroke. Current best treatment is therefore
least effective in the group with the most severe strokes.
Devices that can be fed through the blood vessels to
either remove or break up the blood clot in the brain
vessels are now available, and some small studies have
shown them to be effective at opening large arteries, in
some cases much more effective than drug treatments.
However, using these devices is a highly skilled procedure
and it takes some time both to set up the necessary
facilities (including anaesethetic, nurses and medical
support) and to reach the blockage. The extra time that is
required to use these devices may mean that brain tissue
is already irreversibly damaged. If so, then an individual
patient cannot benefit and indeed may be harmed by
opening the artery. There are no completed clinical trials
comparing the outcome in people treated with standard
stroke treatment and those treated with devices, and we
propose to undertake a randomised controlled trial to test
the effect of devices as an additional treatment in acute
stroke. Total sample size 800 however 70 in the initial
start up phase, which will gather data on event rates that
will inform and refine sample size calculations prior to
commencing on the main phase of the trial.
Funding Body
Stroke Association
- 12 -
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Study Title
RTEASE
Robotic Therapy Early After Stroke Events
Study Type
Acute
Lay Summary
Weakness and impairment of the upper limb is a common
contributing factor to post stroke disability. Specially
designed robotic systems have been developed to try to
improve this. We already know that their use helps
improve limb function after stroke when it has been
present for many months. We do not know whether they
can help early after stroke and enhance recovery of limb
function, and perhaps prevent weakness becoming
chronic. We plan a randomised controlled blinded study to
explore the benefits of robot assisted therapy early after
stroke in 80 stroke survivors. Participants will be
randomised by 7 days after stroke to standard care or to
robotic therapy. Robotic therapy sessions last
approximately one hour and consists of a series of tasks
in first the unimpaired then impaired limb. Twelve
sessions of therapy within the first 4 weeks after
randomisation will be delivered. This study will take 3
years to complete.
Funding Body
Chest, Heart and Stroke Scotland
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Study Title
Study Type
Lay Summary
Funding Body
TARDIS
Safety and efficacy of intensive versus guideline
antiplatelet therapy in high risk patients with recent
ischaemic stroke or transient ischaemic attack: a
randomised controlled trial
Acute
To perform a randomised trial assessing the efficacy,
safety and tolerability of adding Clopidogrel to Aspirin and
Dipyridamole in patients with recent ischaemic stroke or
TIA and who are at high risk of recurrence. The study will
comprise a start up phase of 350 patients to then expand
into a larger trial of up to 5000 patients assessing the
efficacy, safety and health economics of this approach.
We hypothesise that three antiplatelets will be better than
two in preventing further strokes, providing it is not
outweighed by increased bleeding risk. Patients with a
recent stroke or TIA (within 48 hours) will be randomly
assigned to receive either usual stroke treatment (dual
therapy) or Clopidogrel in addition to this (tripletherapy)
for 1 month. There is no placebo.
British Heart Foundation (BHF)
National Institute for Health Research
- 14 -
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Study Title
Study Type
Lay Summary
Funding Body
TITCH 2
Tranexamic acid for IntraCerebral Haemorrhage TICH2
Acute
When someone has a stroke caused by bleeding into the
brain (haemorrhagic stroke) permanent brain damage can
occur and result in long term disability. There is also a
chance that the bleeding can increase, which may cause
worse disability or be life threatening. At present there is
no effective treatment available to reduce the bleeding in
the brain and improving the recovery. New treatments are
being developed to treat stroke, but it can be very hard to
test whether they work in the first few hours because
often patients take longer than this to get to hospital and
have investigations such as brain scanning. Also some
treatments are not suitable for all patients. In this trial,
the aim is to test whether it is possible to give tranexamic
acid to patients in the first few hours after a haemorrhagic
stroke and find out if it reduces the chances of dying and
being left with disability. Tranexamic acid encourages
blood to clot to stop bleeding. Continued or increased
bleeding into the brain (so called haematoma expansion)
is not uncommon in the first hours and days following a
haemorrhagic stroke and increases the risk of the patient
not recovering fully and being left with some disability, or
dying. Stopping the bleeding in the first hours after stroke
with medications might help patients to recover better
and reduce the number of patients who die. The data will
help doctors decide whether blood thickening treatments
like tranexamic acid can be used in patients with acute
haemorrhagic strokes to try and reduce death and
disability and improve
NIHR Health Technology Assessment
- 15 -
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Study Title
Study Type
WAKE-UP
Efficacy and safety of MRI-based thrombolysis in wake-up
stroke: a randomised, double-blind, placebo-controlled
trial
Acute
Lay Summary
About 20% of strokes occur during sleep, and in many
other cases the time of onset cannot be determined
because of communication difficulties resulting from the
stroke and lack of a witness. For patients waking up with
stroke symptoms, or those with unknown time of onset,
the only approved treatment — the delivery of the
thrombolytic (“clot-busting”) drug rtPA — is unavailable to
them. Currently, rtPA has only been proven effective
when given to patients within 4.5 hours after the onset of
stroke symptoms, and because there is concern about the
risk of bleeding associated with treatment if given later,
patients are not eligible for rtPA treatment if the onset
time is unknown.
The WAKE-UP trial will test the safety and effectiveness of
rtPA treatment in patients who wake with stroke
symptoms or have unknown onset time by using brain
scanning with Magnetic Resonance Imaging (MRI) to
identify whether the stroke was likely to have happened
within the 4.5 hour time window. This can be done with a
combination of two types of MRI scan, one that shows
changes very quickly (diffusion-weighted imaging, DWI),
and one where the changes take several hours to become
obvious (FLAIR). Previous studies have shown that scans
where the DWI is abnormal but the FLAIR normal identify
patients with symptoms that started within 4.5 hours
accurately. Patients with this appearance will be randomly
allocated to receive intravenous rtPA or placebo, and
followed up for 90 days to assess outcome.
Funding Body
EU FP7 Funding Stream
- 16 -
PREVENTION STUDIES
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Study Title
CROMIS-2
Microbleeds and genetic risk factors to predict the risk of
intracranial haemorrhage in patients treated with
anticoagulation following cardioembolic stroke due to
atrial fibrillation.
Study Type
Prevention
Lay Summary
Warfarin, a blood thinning medication, is often used after
a stroke due to blood vessel blockage to prevent further
strokes. It is very effective, but has a rare sideeffect of
bleeding into the brain: though this sideeffect is
uncommon, it may be very serious and could counteract
any treatment benefit. Unfortunately at the moment it is
hard to predict the small number of people who will suffer
a brain haemorrhage on warfarin. A special brain scan,
called gradientecho magnetic resonance imaging (MRI),
shows tiny areas of previous bleeding (called
"microbleeds") around leaky, fragile blood vessels. Recent
research suggests that having microbleeds could increase
the risk of suffering a bleed into the brain after treatment
with warfarin. Some people with stroke could therefore be
receiving a risky treatment unnecessarily, but we do not
know this for sure. To find out if this theory is correct, we
will invite a large number of stroke survivors started on
warfarin to take part in this study, where they will have a
gradientecho MRI scans before treatment, and will then
be followed up. This needs collaboration between a
number of different hospitals throughout the UK to
definitively answer this important question. We will also
invite participants to have blood taken for genetic studies
to see if any genetic variations make people more
susceptible to microbleeds or brain haemorrhage after
taking warfarin.
Funding Body
Stroke Association & British Heart Foundation
- 17 -
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Study Title
CVR Lacunar Stroke Study v1.0
Non-invasive measurement of cerebrovascular reactivity
and compliance in cerebral small vessel disease
Study Type
Prevention
Lay Summary
Cerebral small vessel disease is the commonest vascular
cause of dementia, causes a fifth of strokes and physical
disability in older people. The cause is unknown. Failing
bloodbrain barrier function, cerebral arteriolar wall
thickening and impaired vasoreactivity are seen
experimentally or pathologically. In vivo imaging shows
bloodbrain barrier malfunction and can measure cerebral
microvascular reactivity, which is an important potential
therapeutic target in small vessel disease. This project will
test new magnetic resonance imaging methods to
measure regional cerebral vasoreactivity and compliance
in patients with small vessel stroke to determine if these
methods are sensitive and practical enough to use as
intermediary outcomes in early phase clinical trials of
interventions to prevent progressive small vessel disease.
Lack of patient data mean that this development is
required to compare cerebral, retinal and peripheral
vasoreactivity, provide proof of principle and determine
sample size prior to phase 2 trials and mechanistic
studies.
Chief Scientist Office (CSO) of the Scottish Government
Health Directorates
Funding Body
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Study Title
Ecst-2
The 2nd European Carotid Surgery Trial
Study Type
Prevention
Lay Summary
Narrowing of the carotid artery in the neck by fatty
deposits is an important cause of stroke, and hence
disability and premature death. Previous trials have
shown that an operation to remove the narrowing, known
as carotid endarterectomy, is more effective than
treatment with tablets to prevent stroke. In some patients
a treatment called stenting where a wire mesh tube is
inserted via an artery in the groin and opened up across
the narrowing in the neck may be as effective as surgery.
However, drug therapy has improved since the original
trials of surgery. We think medical therapy is now so
effective that the benefits of removing the narrowing may
not justify the risk of surgery or stenting in patients with
a lower risk of stroke e.g. those who have had no
symptoms for some months from the narrowing or never
had symptoms. We propose a clinical trial to determine
whether these patients should be managed by drug
therapy alone or should still be referred for surgery or
stenting. All patients will have their medication adjusted
to reach recommended levels for cholesterol and blood
pressure, and receive advice about healthy lifestyle. Half
the patients will be randomly allocated to have surgery or
stenting as soon as possible, the other half will continue
on medical treatment alone until such time, if ever, that
revascularisation becomes clearly indicated. Patients will
be seen regularly for several years to check their
cholesterol and blood pressure remain on target and to
record surgical complications and the occurrence of
strokes or heart attacks. An interim safety analysis will be
performed using MRI follow up to assess rates of new
cerebral infarction and haemorrhage. The results will be
used to inform patients and doctors choosing which
treatment plan is the safest and most effective for
individual patients.
Funding Body
NIHR Research for Patient Benefit (RfPB)
The Stroke Association
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Study Title
Study Type
Lay Summary
Funding Body
Gluteal biopsy in CADASIL
Characterising the vascular pathophysiology in CADASIL
(Cerebral autosomal dominant arteriopathy with
subcortical infarcts and leukoencephalopathy) by analysis
of gluteal biopsy vessels.
Prevention
Cerebral autosomal dominant arteriopathy with
subcortical infarcts and leukoencephalopathy (CADASIL) is
an inherited disease affecting small blood vessels. It
results from a reduction of blood flow to certain parts of
the brain. The most common symptoms of the disease,
which develop in adulthood, include migraine, depression
and strokes. Patients develop problems with walking,
speech and progressive impairment of memory resulting
in dementia.CADASIL is the most common inherited cause
of stroke, and at present there is no treatment. CADASIL
is caused by an abnormality (mutation) in a gene called
NOTCH3. Genes produce proteins necessary for the
normal functioning of cells. NOTCH3 is thought to help to
maintain muscle cells that regulate the blood flow in small
arteries (vascular smooth muscle cells). In CADASIL,
faulty NOTCH3 causes reduced blood flow that damages
brain tissue. Damaged arteries and abnormal blood flow
are seen in other organs, including the skin, but
symptoms are only seen in the brain. Our understanding
of how abnormalities in NOTCH3 lead to abnormal blood
vessel function is poor. We wish to investigate
abnormalities that might explain altered blood vessel
function by taking a small sample of muscle and skin
(called a biopsy) from the buttock of individuals with
CADASIL. Participants will undergo a single biopsy under
a local anaesthetic. Arteries will be removed from the
sample for laboratory study of their structure and
function. Individual muscle cells will be grown to produce
larger numbers (cultured). Skin cells may also be used to
generate stem cells, cells which are capable of dividing
into different types of cells many times, to compare
"young" blood vessel muscle cells with "older" ones. The
details of each individual’s symptoms and disability will be
recorded. Cells will be kept indefinitely.
Stroke Association
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Study Title
RESTART
REstart or STop Antithrombotics Randomised Trial
Study Type
Prevention
Lay Summary
More than one third of the adults with a stroke due to
bleeding into the brain – known as brain haemorrhage –
are taking drugs to prevent clotting when they have a
brain haemorrhage. These patients had previously
suffered illnesses like angina, heart attack, or stroke due
to blood vessel blockage, which is why they are treated
with drugs to prevent further clots occurring. These drugs
are usually stopped when the brain haemorrhage occurs.
But when patients recover from brain haemorrhage, they
and their doctors are often uncertain about whether to
restart these drugs to prevent further clots occurring, or
whether to avoid them in case they increase the risk of
brain haemorrhage happening again.
In this preliminary study of 720 such people who survive
a brain haemorrhage, we will study the potentially
beneficial effects of antiplatelet drugs such as aspirin on
the risks of heart attack, stroke and other clotting
problems as well as their effect on the risk of a brain
haemorrhage happening again. This information will help
us to decide whether antiplatelet drugs are a promising
treatment. If they are, we will recruit a much larger
number of patients so that we can determine really
reliably whether the beneficial effects of antiplatelet drugs
on the risk of clotting outweigh any risks of a repeat brain
haemorrhage for such people.
Funding Body
British Heart Foundation
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Study Title
Study Type
XILO-FIST
Xanthine oxidase Inhibition for improvement of Long-term
Outcomes Following Ischaemic Stroke and Transient
ischaemic attack
Prevention
Lay Summary
Recurrent stroke and cognitive decline are common after
ischaemic stroke. Allopurinol, a drug usaully used to treat
gout, has been shown to reduce heart ischaemia, heart
size, and arterial stiffness and to relax brain blood vessels
and may reduce the blood pressure. All of these
properties may be associated with a lower risk of second
stroke and cognitive decline. We now aim to explore
whether allopurinol will reduce further damage to the
brain (called white matter hyper-intensities) after stroke
and also whether it reduces heart size and blood pressure
after stroke.
We will conduct a multi-centre randomised, double-blind
placebo controlled study to investigate whether two years
allopurinol 300 mg twice per day (BD) improves these 3
surrogate outcomes, which are inextricably linked to risk
of recurrence and cognitive decline after ischaemic stroke.
Funding Body
British Heart Foundation and Stroke Association
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REHABILITATION STUDIES
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Study Title
ACCESS
Acceptability of Community Cycling Exercise for Stroke
Survivors
Feasibility of a community based cycling exercise
programme in stroke survivors.
Study Type
Rehabilitation
Funding Body
This project will assess the feasibility of conducting a
randomised controlled trial for a community based cycling
exercise programme to improve physical and
psychological outcomes in stroke survivors. Stroke is the
leading cause of disability in the UK. The role exercise has
in improving function and preventing future ill health was
placed in the top ten research priorities by stroke
survivors, carers and health professionals. After discharge
from in-patient care, the options for regular exercise for
stroke survivors are often limited to local council funded
facilities. This study will assess the feasibility
(recruitment, retention, appropriateness, safety and
acceptability) of a cycling based exercise intervention
programme, designed to run within existing local council
services, for both ambulatory and non-ambulatory stroke
survivors. The appropriateness, safety and acceptability of
the programme will be assessed using semi-structured
interviews and focus groups and added to quantitative
measures of recruitment, retention, adverse events and
adherence.
Chief Scientist Office (CSO) of the Scottish Government
Health Directorates
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Study Title
BIG CACTUS
Cost effectiveness of aphasia computer treatment versus
usual stimulation or attention control long term post
stroke
Study Type
Rehabilitation
Lay Summary
Aphasia is a communication disorder often caused by
stroke. It can affect the ability to understand what is said,
the ability to produce correct words and the ability to read
and write. People with aphasia rarely receive treatment
from NHS speech and language therapists for more than 3
months. It has been established that people with aphasia
can continue to improve their communication with
prolonged treatment (beyond 12 months). However this is
rarely available. Surveys indicate that people with aphasia
and their families often feel abandoned when therapy is
discontinued and want to continue making efforts to
improve (Stroke Survey 2006). Step-by-Step is a
computer program designed to help people to practise
exercises to improve their ability to find the correct words
when they are talking. Following a successful pilot, this
study aims to compare computer therapy with attention
control (puzzle books) and usual care to see if use of
computer software with assistance from a
volunteer/speech therapy assistant can improve the
ability of people with aphasia to talk. This research will
establish whether people with aphasia can continue to
improve their ability to talk after completion of traditional
NHS therapy, and whether this can be achieved cost
effectively by offering computer treatment at home.
Potential benefits to patients include the opportunity for
continued treatment and thus improved ability to talk. It
could also give patients independence and control over
their therapy. The NHS would benefit by being able to
support a long term aphasia treatment services without
increasing demand on therapy resources.
Funding Body
NIHR Health Technology Assessment
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Study Title
Study Type
Lay Summary
EVERLAP
Early VERsus Later Augmented Physiotherapy compared
with usual upper limb physiotherapy: an exploratory RCT
of arm function after stroke.
Rehabilitation
This study explores the benefits of extra arm
physiotherapy to improve arm/hand (“arm”) function after
stroke, compared to usual arm physiotherapy after stroke.
Participants will randomly receive extra arm
physiotherapy, either within 3 weeks (“early”) or at 3
months (“later”) after stroke, or usual arm physiotherapy.
It also explores the feasibility of a large study of extra
arm physiotherapy.
Intervention: Extra arm physiotherapy is a 6-week
programme with 6 sessions per week, 45 minutes per
day, aimed at improving arm/hand function. It comprises
a range of evidence-based treatments, which will be
selected according to each participant’s needs and goals.
To remind participants to carry out specific arm activities,
they can choose between a mobile phone reminder
service and a workbook.
Funding Body
Outcomes: (a) feasibility (i.e. patients’ views, recruitment
rates, drop-outs, safety, cost). (b) arm function, amount
of arm activity, quality of life, personal goal attainment,
mood, carer burden.
Chartered Society for Physiotherapy
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Study Title
Examining a 'life after stroke' helpsheet for stroke
survivors
Examining the process, feasibility and acceptability of the
'Selection, Optimisation and Compensation (SOC)'
helpsheet intervention for stroke survivors
Study Type
Rehabilitation
Lay Summary
Stroke survival rates are improving, with a 60% reduction
in mortality in Scotland over the past 20 years. It has,
therefore, become increasingly important to research
ways to help stroke survivors cope with the long-term
consequences of stroke. Half of all stroke survivors suffer
from one or more impairment and stroke is a leading
cause of disability worldwide. Currently, stroke survivors
in Scotland have access to rehabilitation services, which
often focus on improving function and increasing stroke
survivors’ ability to complete certain tasks. Interventions
focusing on improving overall adaptation or coping are
rare. The behavioural strategies stroke survivors use, for
example, to adapt to their new difficulties are rarely
examined. Strategies such as problem solving, acceptance
and allowing help from others are suggested to be linked
to better adjustment. The Selection, Optimisation and
Compensation model (Baltes & Baltes, 1990) may provide
an ideal framework to examine how stroke survivors
adapt, describing three types of strategies that are
suggested to result in improved wellbeing and satisfaction
with life. The SOC model has been used to investigate
‘successful aging’ where older adults continue to
experience life satisfaction and reach their goals despite a
loss of function, such as mobility or cognitive decline.
Such a loss in ability is commonly experienced by stroke
survivors. A previous study has found that stroke
survivors use a number of different strategies to help
them adapt to their difficulties. The research team have
used these strategies to form a ‘help sheet’, which will
allow other stroke survivors to learn about the SOC
approach and try out ways of adjusting to life after stroke.
This pilot research will examine whether this SOC ‘help
sheet’ approach is acceptable to stroke survivors and
further examine any behaviour change processes which
occur through taking part in the study.
Funding Body
Chest Heart & Stroke Scotland
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Study Title
Long term consequences and recovery from stroke:
what is important to stroke survivors and health
professionals?
Study Type
Rehabilitation
Lay Summary
We will explore what stroke survivors and health
professionals think are the most important long term
consequences of stroke and whether current stroke
outcome scales adequately assess these.
PHASE 1: Stroke survivors who are at least 18 months
post-stroke and health professionals working in stroke
care will be invited to participate in small focus groups or
individual interviews. We will ask these people to tell us
which long term consequences matter most to them. We
will also explore whether the most common way of
measuring stroke outcome (a measurement scale called
the modified Rankin Scale (mRS)) measures what is
important to stroke survivors and health professionals.
We will do this by asking participants to rate the recovery
of individual videotaped stroke survivor interviews and
discuss their reasons. We will also ask what long term
consequences are not assessed adequately by the mRS.
PHASE 2: We will take the findings from PHASE 1 and
explore which long term consequences matter most and
how opinions differ between stroke survivors and health
professionals. As in phase 1, participants will be invited to
take part in small groups or individual interviews to
complete the card-sorting exercise. This involves ranking
the importance of a series of statements.
PHASE 3: The results of phases 1 and 2 will then be used
to bring together existing evidence about long term
consequences of stroke through a systematic review of
the literature. The review will include outcomes that
represent the important domains shown by our study. We
will select those studies addressing the long term
consequences of stroke identified as being of greatest
importance to stroke survivors and health professionals.
This will help us make recommendations for stroke
outcome scales which measure what is important to
people affected by stroke. In this way our project will
support future research into how best to help people
manage the long term consequences of stroke.
Funding Body
Chief Scientist Office
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Study Title
The MELLO Study
Measuring the Effects of Listening for Leisure On recovery
after stroke: a pilot randomised controlled trial
Study Type
Rehabilitation
Lay Summary
Stroke is the biggest cause of disability in older adults.
Early post-stroke rehabilitation focuses primarily on
physical disability and activities of daily living. By
contrast, relatively little research attention has been paid
to the potential for cognitive rehabilitation and moodenhancing interventions in the early stages after stroke.
Low mood and cognitive difficulties with attention and
memory are common post-stroke leading to poorer
recovery, emotional wellbeing and quality of life yet
accessible and effective therapies are lacking.
Engagement in leisure activities may enhance recovery
after stroke but participation in leisure activities is
reduced following stroke. Music listening is a low cost and
accessible leisure activity that has been suggested to
improve mood and cognition post-stroke. We speculate
that music listening may enhance control of attention in a
similar way to mindfulness interventions, that have been
demonstrated to be beneficial in the treatment of mood
disorders. We propose that adding a brief mindfulness
intervention to music listening might enhance the effect
on control of attention, with positive effects on cognition
and mood post-stroke but the feasibility and acceptability
of this intervention needs to be evaluated before
attempting a further trial assessing the effectiveness of
this intervention. We aim to recruit 100 people within two
weeks post-stroke. Participants will be randomly assigned
to receive an 8-week music listening alone, music
listening with brief mindfulness or audiobook listening
intervention alongside treatment as usual.
Neuropsychological assessment of cognition and mood will
be performed at baseline, 3 months, and 6 months poststroke In addition, participants will be interviewed about
their experience of engaging in the interventions.
Funding Body
The Dunhill Medical Trust
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Study Title
Non-invasive Brain Stimulation in Stroke Patients
Study Type
Rehabilitation
Lay Summary
We propose to carry out a pilot trial in patients with poststroke neglect comparing non-invasive brain stimulation
(TDCS) with action training, applied separately & in
combination, compared to a control intervention in a 2x2
factorial design. We will assess how the interventions
change the neglect symptoms but most importantly
investigate the impact of these interventions in terms of
changes to dependence & quality of life, including a late
time point. We are thus looking to confirm the choice of
primary outcomes for the definitive trial: Multiple
neuropsychological outcome measures with established
validity and reliability will ensure a comprehensive
assessment of neglect and more generally stroke severity
and its recovery. In particular as the primary outcome,
assessment and recovery of neglect will be assessed with
standardised tasks such as: the Behavioural Inattention
Test (BIT, Wilson et al., 1987), the Balloons test (see
Rossit et al., 2009 for a description of both tests) and the
Line Bisection task (Harvey et al., 2010). Transfer to
activities of daily living will be measured with the Stroke
Impact Scale (Duncan et al., 2003), an interviewadministered measure of stroke recovery, specifically
designed for repeated administrations which very
sensitively detects changes in everyday behaviour. Quality
of life changes will be monitored with the EuroQQL/SF -36
(vs2) Health Survey, which is used internationally & has
shown to be reliable and valid (over the last 25 years).
Mood changes will be assessed with the Beck Inventory
(Beck et al., 1996). For the 4 groups (action-training,
TDCS, combined and control training), changes in all
these outcome measures will be compared before the
intervention, at 2 weeks (10 sessions) & 6 months posttreatment. However for this pilot, we will also assess
recruitment & retention rates (will patients be more likely
to withdraw from one arm than another?), compliance
(will this differ between the arms), & patient satisfaction
Chief Scientist Office (CSO) of the Scottish Government
Health Directorates
Funding Body
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Study Title
OSPREy
Observation of Sit-to-Stand Practice in Rehabilitation.
Current levels of sit to stand practice among stroke
survivors during rehabilitation: a pilot observational study
exploring determining factors.
Study Type
Rehabilitation
Lay Summary
Standing up from a seated position is a frequently
performed movement critical to independent living. For
stroke survivors, the safe, independent, execution of this
task can be challenging. As modest amounts of repetitive
practice have been shown to improve performance, sit to
stand (STS) practice is a recommendation for stroke
rehabilitation. Despite this, our knowledge of STS practice
(both during formal therapy sessions and informally as
part of their daily routine) is very limited. Factors related
to the patient (e.g. body mass), the stroke (e.g. severity)
and the environment (e.g. availability of therapists) are
all likely to influence frequency and success of practice,
however, the impact of these factors has not been
investigated.
The primary aim of this study is to describe stroke
survivors’ level of STS practice (formal and informal).
Secondly we wish to identify factors associated with
variation in practice. This information will inform current
practice and allow us to explore models and “dosing” of
STS practice delivery to inform future research.
The study is an observational study of STS practice during
the rehabilitation period of stroke survivors. We will
recruit stroke survivors currently receiving rehabilitation
from the NHS. Each participant will be asked to wear a
small lightweight sensor on one of their thighs for 14
days. This sensor is able to record every transition
between sitting and standing. We will also record factors
from the medical notes and from the participants which
may explain some of the variation in STS practice, for
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example age, body mass, and severity of stroke.
Funding Body
Chest, Heart and Stroke Scotland
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Study Title
Study Type
Lay Summary
Funding Body
RATULS
Robot Assisted Training for the Upper Limb after Stroke
Rehabilitation
Loss of arm function is a common and distressing
consequence of stroke. Currently it is unclear how best to
provide therapy to improve arm recovery. Research
suggests that robot-assisted training may be beneficial
but this is not yet proven and further research is needed.
Robot-assisted training consists of the use of a machine
or ‘robot’ to exercise the arm. This research study is a
three group multicentre randomised controlled trial to
determine whether robot-assisted training improves upper
limb function after stroke. Robot-assisted training will be
compared to i) an enhanced upper limb therapy
programme consisting of repeated practice of everyday
activities using the arm and ii) usual NHS rehabilitation.
Stroke patients with reduced arm function who wish to
take part in the trial will be randomly assigned to either
robot-assisted training, enhanced upper limb therapy or
usual NHS rehabilitation. Robot-assisted training and
enhanced upper limb therapy will be delivered for 45
minutes, 3 times per week for 12 weeks, in addition to
usual rehabilitation. Robot-assisted training will use the
InMotion robotic gym system which comprises three
modules to exercise the shoulder/elbow, wrist and hand.
Enhanced upper limb therapy will consist of upper limb
rehabilitation goal setting followed by practice of everyday
activities to work towards the goals. The effectiveness of
robot-assisted training will be evaluated by comparing the
upper limb function of patients in each randomisation
group at 3 and 6 months. The study will run for 57
months and aims to recruit 720 stroke patients from up to
16 NHS stroke services and their surrounding primary
care localities.
NIHR Health Technology Assessment
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Study Title
SOCLE II
(Stroke Oral healthCare pLan Evaluation
Study Type
Lay Summary
Rehabilitation
Stroke associated pneumonia (SAP) affects a fifth of
stroke survivors annually, tripling the risk of death at 30
days and contributing to poorer rehabilitation outcomes,
prolonged hospital stays and dependency at discharge.
Systematic review evidence indicates that enhanced oral
health care (OHC) has a preventative effect on the
incidence of pneumonia amongst nursing home
populations (absolute risk reductions 6.6% to 11.7%;
numbers needed to treat 8.6 to 15.3 individuals). There
are strong theoretical reasons to suggest similar benefits
might be observed in stroke care settings but current
empirical evidence is weak - trial quality (randomisation,
blinding, sample size, reporting), intervention description
and thus feasibility of translation into clinical practice is
very poor. Following an extensive pre-clinical programme
of work, we seek funding to support the pilot phase
(Phase II) of a stepped-wedge cluster RCT of a welldeveloped and defined complex OHC intervention versus
usual OHC. We aim to establish a robust web-based
randomisation process, refine our proposed intervention
(training, tools, equipment), recruitment, adherence,
record linkage and sampling methodologies. We also aim
to establish the relationship between SAP and plaque and
any diversity between sites. Our proposed pilot work will
support an application to NIHR/HTA for a planned Phase
III definitive trial.
Funding Body
Stroke Association
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Study Title
TEARS
Testing for Emotionalism after Recent Stroke
Study Type
Rehabilitation
We think emotionalism after stroke (uncontrollable crying)
is common, but we cannot be sure because only a few
studies have looked at it. We think emotionalism has a
negative effect on quality of life, mood, thinking skills and
social/physical functioning. Again we cannot be sure
because this has never been properly measured. We
know little about stroke types which lead to emotionalism,
how emotionalism is kept going and how it can be made
better using talking therapies (psychology) rather than
pills.
Lay Summary
We want to study a large group of people with stroke
starting a few days after their illness and follow them up
for a year, to clarify these issues regarding emotionalism.
We really want to understand what contributes to
persistent emotionalism. We will compare stroke
survivors who don’t get emotionalism to stroke survivors
who do get emotionalism. We will ask the people who
have emotionalism, what they do to manage it.
Results will show us:
 How common emotionalism is
 Which type(s) of stroke cause it
 How it impacts life quality, mood, thinking skills
and social/physical recovery
 and how people cope with it and help us develop a
new talking
The research will have a big impact on stroke survivors.
Because so few studies have been done on emotionalism,
stroke doctors and other health professionals must advise
patients and families based on incomplete facts.
Funding Body
Stroke Association
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Study Title
TREAT UI
Tranexamic acid for IntraCerebral Haemorrhage TICH2
Study Type
Rehabilitation
Lay Summary
When someone has a stroke caused by bleeding into the
brain (haemorrhagic stroke) permanent brain damage can
occur and result in long term disability. There is also a
chance that the bleeding can increase, which may cause
worse disability or be life threatening. At present there is
no effective treatment available to reduce the bleeding in
the brain and improving the recovery. New treatments are
being developed to treat stroke, but it can be very hard to
test whether they work in the first few hours because
often patients take longer than this to get to hospital and
have investigations such as brain scanning. Also some
treatments are not suitable for all patients. In this trial,
the aim is to test whether it is possible to give tranexamic
acid to patients in the first few hours after a haemorrhagic
stroke and find out if it reduces the chances of dying and
being left with disability. Tranexamic acid encourages
blood to clot to stop bleeding. Continued or increased
bleeding into the brain (so called haematoma expansion)
is not uncommon in the first hours and days following a
haemorrhagic stroke and increases the risk of the patient
not recovering fully and being left with some disability, or
dying. Stopping the bleeding in the first hours after stroke
with medications might help patients to recover better
and reduce the number of patients who die. The data will
help doctors decide whether blood thickening treatments
like tranexamic acid can be used in patients with acute
haemorrhagic strokes to try and reduce death and
disability and improve recovery.
Funding Body
NIHR Health Technology Assessment
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