Neuromodulation for Headache
and Craniofacial Pain
Alon Y. Mogilner, M.D., Ph.D.
Chief, Section of Functional and Restorative Neurosurgery
Cushing Neuroscience Institutes
Hofstra - North Shore – LIJ School of Medicine, Manhasset, NY
Disclosures

Alon Y. Mogilner, M.D., Ph.D. receives honoraria
and grant support from Medtronic, and grant
support from St. Jude Medical
 Peripheral Neuromodulation for Headache and
Craniofacial Pain is not FDA approved, and thus
represents an off-label indication.
Introduction
Neurosurgical management of chronic headache and
craniofacial pain syndromes has been an evolving
concept over the past 50 years
 Early interest in neurostimulation, for these conditions,
focused on deep brain targets
 Hosobuchi, Adams, and Rutkin, thalamic stimulation to
treat facial anesthesia dolorosa, 19731
 Mazars and Pull, intermittent stimulation of nVPL to
treat intractable headache, 19762

1.
2.
Hosobuchi Y, Adams JE, Rutkin B. Chronic thalamic stimulation for the control of facial anesthesia
dolorosa. Arch Neurol 1973;29(3):158-61.
Mazars G, Pull H. Neurosurgical treatment of headaches. Minerva Med 1976; 67(31):2020-2.
Occipital Nerve Stimulation



Goadsby (1997): Stimulation of greater occipital nerve
(GON) in cats resulted in increased metabolic activity
of the trigeminal nucleus caudalis and cervical dorsal
horn3
Weiner (1999): Peripheral neurostimulation for occipital
neuralgia4
Goadsby (2004): ONS for migraine headache5
3. Goadsby PJ, Knight YE, Hoskin KL. Stimulation of the greater occipital nerve
increases metabolic activity in the trigeminal nucleus caudalis and cervical dorsal horn
of the cat. Pain 1997; 73(1):23-8.
4. Weiner RL, Reed KL. Peripheral neurostimulation for control of intractable occipital
neuralgia. Neuromodulation 1999; 2(3):217-21.
5. Matharu MS, Bartsch T, Ward N, Frackowiak RSJ, Weiner RL, Goadsby PJ. Central
neuromodulation in chronic migraine patients with suboccipital stimulators: A PET
study. Brain 2004;127:220-30.
Peripheral Stimulation: headache
and facial pain

Most Common technique:
◦ Occipital Nerve Stimulation
 Occipital stimulation
 “BOTH” stimulation

Other techniques:
◦ Trigeminal branch stimulation
 Supraorbital
 Supratrochlear
 Auriculotemporal
Anatomy
The occipital nerves are derived from C2
 The C2 ventral ramus merges with the cervical plexus
and contributes to the lesser occipital nerve
 The sensory medial branch of the C2 dorsal ramus
contributes to the greater occipital nerve

Mechanisms
The mechanism of action of ONS has not been fully
elucidated
 Afferents from pain-producing cranial structures (dura,
blood vessels) likely source of primary headache
syndromes
 Pain oftentimes is not constrained within trigeminal
innervation territories
 There is frequently involvement of GON innervation
territories

Mechanisms
Role of Trigemino-Cervical Complex?
 Afferents from meninges terminate in caudal trigeminal
nucleus, in medullary dorsal horn
 This nucleus extends down to C2
 Afferents from back of head travel along GON to C2
 Convergent Neurons
 Plasticity
 This model may not apply though
 Mechanism may actually be more similar to peripheral
field stimulation (Pain Gate)

Epidermis
Dermis
Subcutaneous Tissue
Electrode
Subcutaneous
nerves
Headache/Facial Pain
Headache
Tension headache
Migraine and equivalents
Non-neurogenic pain
Sinusitis
TMJ pain
Cervicogenic headaches
Occipital neuralgia
Cluster headache
Trigeminal neuralgia
Trigeminal Neuropathic pain
Postsurgical pain
Postherpetic neuralgia
Anesthesia dolorosa
Central Post-Stroke pain
Other cranial neuralgias
Headache/Facial Pain
Headache
Tension headache
Migraine and equivalents
Non-neurogenic pain
Sinusitis
TMJ pain
Trigeminal neuralgia
Neuropathic pain
Postsurgical pain
Postherpetic neuralgia
Anesthesia dolorosa
Central post-stroke pain
Cervicogenic headaches Atypical facial pain
Occipital neuralgia
Cluster headache
Burchiel Classification of Facial
Pain
•
•
•
•
•
•
•
Trigeminal neuralgia, type 1, (TN1): facial pain of
spontaneous onset with greater than 50% limited to the duration
of an episode of pain (temporary pain).
Trigeminal neuralgia, type 2, (TN2): facial pain of
spontaneous onset with greater than 50% as a constant pain.
Trigeminal neuropathic pain, (TNP): facial pain resulting
from unintentional injury to the trigeminal system from facial
trauma, oral surgery, ear, nose and throat (ENT) surgery, root injury
from posterior fossa or skull base surgery, stroke, etc.
Trigeminal deafferentation pain, (TDP): facial pain in a
region of trigeminal numbness resulting from intentional injury to
the trigeminal system from neurectomy, gangliolysis, rhizotomy,
nucleotomy, tractotomy, or other denervating procedures.
Symptomatic trigeminal neuralgia, (STN): pain resulting
from multiple sclerosis.
Postherpetic neuralgia, (PHN):pain resulting from trigeminal
Herpes zoster outbreak. (SHINGLES).
Atypical facial pain, (AFP): is facial pain of unknown origin.
IHS ICHD-II Classification
Peripheral Stimulation: Procedure

Percutaneous trial performed under local
anesthesia
◦ ONS: Supine with head turned lateral position preferred
 prone position used in patients who could not be positioned supine/lateral
◦ Lateral or prone position
◦ Trial performed under local anesthesia with sedation (propofol,
dexmetetomidine, versed)
◦ Intraoperative testing not always performed
◦ Leads placed horizontal approximately 1 cm above level of C1 arch
 May depend on previously placed hardware
 OC fusion hardware,
 VP shunt hardware
Procedure
ONS: technique
• Cranial and cervical hardware may alter patient positioning, electrode
placement
Procedure: Percutaneous Trial

Outpatient trial analogous to SCS trial (4-7
days)
◦ Special considerations:
 Chronic migraine
 H/A wax and wane with menstrual cycle
 Cluster headache
 Delay in onset of efficacy
 Headache location:
 Frontal H/A with no radiation from occipital region
 Consider trigeminal branch leads
Procedure: Permanent Implant

Patients usually return with trial leads in place
◦ Leads are removed after induction of general
anesthesia
◦ New leads placed and anchored to retromastoid
fascia
 Extensions rarely used
◦ Generator location:
 infraclavicular (most common)
 Flank/buttock
 abdomen
Procedure: Permanent Implant
Complications


Lead migration: most
common ONS complication
Surgical technique, anchoring
technique not standardized
Complications: Wound Erosion


Be proactive regarding
potential wound erosions
Hardware not optimized for
peripheral applications
Complications: System Revision
Complications…
Results: Literature
Survey
NANS 2009
Neurostimulation for Migraine:
Clinical Trials


3 to date, Boston Scientific, Medtronic, St. Jude
Most recent: St. Jude study
◦ Significant group differences for reduction in number of headache days,
MIDAS, Zung PAD,VAS, quality of life and satisfaction at 12 weeks were
observed (p< 0.05).
◦ In the Active and Control groups respectively, number of headache days
(defined as a > 4 hours duration at moderate intensity) decreased by
7.3 and 4.3, total MIDAS scores improved by 64.6 and 20.4, MIDAS
headache days improved by 22.5 and 3.4, PAD scores improved by 13.3
and 5.5, VAS scores decreased by 13.6 and 6.9, 37.1% and 17.3% of
patients achieved a 30% reduction in VAS.
◦ In addition, 66.7% of patients in the Active group reported improved
quality of life whereas only 17.2% of patients in the control group
reported the same. For satisfaction, 51.4% of patients in the Active
group reported being satisfied whereas only 19.2% in the Control group
reported being satisfied.
◦ HOWEVER, primary endpoint (>50% pain reduction) not reached
Peripheral Neuromodulation for
Headache and Craniofacial Pain:
Indications, Outcomes, and Complications
from a Single Center
Antonios Mammis, M.D.1,2, and Alon Y. Mogilner, M.D.1, Ph.D.
1Cushing
Neuroscience Institutes
Hofstra - North Shore – LIJ School of Medicine, Manhasset, NY
2Department of Neurological Surgery
UMDNJ – New Jersey Medical School, Newark, NJ
Objectives



To review the indications and outcomes of peripheral
neurostimulation for headache and craniofacial pain,
from a single center experience
To adopt a uniform classification scheme for headache
and craniofacial pain, which is understood by the
headache community, across multiple disciplines
To review complications and promote strategies of
complication avoidance
Methods
Retrospective chart review from a single center
 2004-2011
 99 patients underwent peripheral neurostimulator trials
for headache / craniofacial pain
 Retrospective classification of diagnoses according to
the International Headache Society (IHS): ICHD – II
classification scheme
 All procedures performed by AYM
 8 of the migraine patients were part of a multicenter
randomized study (St. Jude Medical)
 Procedures performed included ONS and / or
trigeminal branch stimulation

Demographics
74 Females
 25 Males
 Mean Age: 43 (Range 11-68 yrs old)

Diagnoses: ICHD – II System
Diagnosis
Number of Patients
7.7: Headache attributed to Chiari Malformation type I
28
1.1 or 1.2: Migraine Headache with or without Aura
24
5.2.2: Chronic post-traumatic headache attributed to mild head
injury
11
13.8: Occipital Neuralgia
8
5.7.2: Post-Craniotomy Headache
7
3.1.2: Chronic Cluster Headache
5
6.1.1: Headache attributed to ischemic stroke
5
13.7: Other terminal branch neuralgias
5
11.2.1: Cervicogenic Headache
4
4.7: Hemicrania Continua
1
7.4.4:Headache attributed to hypothalamic or pituitary hyper- or
hyposecretion
1
Technique







Trials performed under local anesthesia with
intravenous sedation
Bilateral Approach
Intra-operative testing not performed, in most cases
Surface anatomy and fluoroscopy for lead placement
8 or 4 contact percutaneous leads
Trial Period (4-7 days)
Headache Diary: duration, frequency, and severity
(Visual Analog Scale)
Technique
Permanent implantation under general anesthesia
 Patient position depended on anatomy and planned
location of pulse generator
 Bilateral lead placement, from a unilateral approach
 Radiographic confirmation of lead placement
 Pulse generator placed in subcutaneous pocket

Results



79/99 (80%) patients reported significant improvement
during trial
Improvement was defined as 50% pain relief on VAS
These patients proceeded to permanent implantation
Results

56/79 (71%) Occipital Leads Only
Results

12/79 (15%) Trigeminal Branch Only
58 year old male s/p brainstem CVA with resultant
left V1 and V3 distribution pain. Underwent trial and
subsequent implant of left V1 (A) and V3 (B) region
peripheral neurostimulators, with significant
improvement in pain duration, frequency, and
severity.
Results

11/79 (14%) Both Occipital and Trigeminal
Branch Leads
18 year old male with chronic cluster headache.
Intra-operative AP skull radiograph, demonstrating
supraorbital (A), infraorbital (B), and occipital (C)
neurostimulation leads. At 3 years follow-up, he
reported significant improvements in headache
duration, frequency, and severity.
Results
Follow-up ranged from 1-65 months
 Mean follow up: 9 months
 At last follow-up, 65/79 (82%) patients, who underwent
implantation, reported continued significant benefit from
stimulator use.

Results: Analysis of Indications
Diagnosis
Number
of
Patients
Number of
Successful
Trials
Number of
Permanent
Systems still
used at Last
Follow-up
7.7: Headache attributed to Chiari
Malformation type I
28
18
15
1.1 or 1.2: Migraine Headache with or
without Aura
24
21
19
5.2.2: Chronic post-traumatic headache
attributed to mild head injury
11
10
8
13.8: Occipital Neuralgia
8
7
7
5.7.2: Post-Craniotomy Headache
7
7
6
3.1.2: Chronic Cluster Headache
5
4
4
6.1.1: Headache attributed to ischemic
stroke
5
3
1
13.7: Other terminal branch neuralgias
5
4
1
11.2.1: Cervicogenic Headache
4
3
3
4.7: Hemicrania Continua
1
1
1
7.4.4:Headache attributed to hypothalamic
or pituitary hyper- or hyposecretion
1
1
0
Complications

Lead Migration necessitating Revision: 4/79 (5%)
Migration of left occipital lead (*), in a
patient with migraine headaches.
Left occipital lead replaced after
revision surgery.
Complications
Wound erosion / infection, necessitating
explantation: 3/79 (4%)
 Surgical site infection without wound erosion,
necessitating explantation: 3/79 (4%)
 Of the 6 patients with infection, 3 were
following initial implant and 3 followed revision
 Impending wound erosions were surgically
revised, preemptively

Other Complications



Revision surgery for other reasons:
17/79 (22%)
Superficial Placement / Cosmesis
Distal to Proximal Revision
Technique allowed for quick
corrections of lead position,
without exposing pulse generator
site
Illustration demonstrating the distal to proximal
neurostimulator lead revision technique in a case
of a supraorbital stimulator. The original lead, in
situ (A). The temporal incision is opened and
the lead is pulled through (B). A curved spinal
needle is introduced through a forehead stab
incision to the temporal incision, in a plane
deeper than the original lead (C). The stimulator
lead is then introduced through the spinal needle
and tunneled deeper in a proximal to distal
fashion (D).
Mammis A, Mogilner AY. A technique of distal to proximal revision of
peripheral neurostimulator leads: technical note. Steretact Funct Neurosurg
2011;89(2):65-9.
Conclusions



Peripheral neuromodulation is efficacious in a number
of headache and craniofacial pain disorders
Migraine Headache: most studied – CE approval
obtained, FDA approval not as yet
Other headaches (trigeminal autonomic cephalalgias)
respond well to neurostimulation