A New Look at an Old Workhorse: A Pilot Study of Z-Score Sensorimotor &

Individualized Neurofeedback

See full text at: Hammer, B.U., Colbert, A.P., Brown, K.A. and Ilioi, E. C. (2011).

Neurofeedback for Insomnia: A Pilot Study of Z-Score SMR and Individualized

Protocols. Appl. Psychophysiol Biofeedback, DOI 10.1007/s10484-011-9165-y

Email: barbhammer37@yahoo.com

Barbara U. Hammer, Ph.D., Agatha P. Colbert, MD, Kimberly A. Brown,

MSOM, Helfgott Research Institute, National College of Natural

Medicine, Portland, OR, Elena C. Ilioi, Psychology Honours, McGill

University, Montreal, Quebec, Canada

The authors are grateful to the Helfgott Research Institute of the National

College of Natural Medicine in Portland, Oregon for its generous support of this research. We are especially appreciative of the help from Mark L.

Smith and Nancy Wigton on the design of the protocols, William Gregory and Heather Jaskirat Wild for her assistance with the data analysis, and the generous support of our research assistants, Sean E. Griffith and

Tineke Malus. We thank all those who participated in this study, including those who took the time to complete the telephone screening and the extended screening sessions but who were not offered the opportunity to continue and to receive treatment.

Insomnia Definition

Primary Insomnia (DSM 307.44): Complaints of Difficulty

Falling Asleep, Staying Asleep or Awakening too early, or

Non-restorative Sleep which occurs for at least one month and:

1. Causes significant distress or impairment in social, occupational, or other important areas of functioning.

2. Does not occur exclusively during the course of

Narcolepsy, Breathing-Related Disorder, Circadian Rhythm

Sleep Disorder or a Parasomnia.

3. Does not occur exclusively during the course of another mental disorder.

4. Is not due to the direct physiological effects of a substance or general medical condition .

2005 NIH Conference on Insomnia declared Insomnia an

Epidemic:

 20-30% of adults in the U.S. suffer from Insomnia\

 Insomnia associated with increased

Illness, accidents, healthcare utilization, and industrial expenses

Costs estimated at $14-80 billion annually

 Pharmacotherapy limited due to negative side effects

• Psychological treatments

• highest co-morbidity

• Insomnia persists despite psychotherapy for depression or anxiety

Cognitive Behavior Therapy —

• demonstrated 70% efficacy , effectiveness, efficiency for treatment of Insomnia but seldom used

• difficult to administer requiring specialized training/many sessions

• Challenges remain primarily in service delivery system. Internet based program promising

• Neurofeedback

SMR from Sterman 1960’s to Hauri (1980’s)=cats to humans, improved sleep

Theta benefitted tense insomniacs

Individualized studied here

Peter Hauri (9/2008):

SMR Neurofeedback in 1980’s used Analog

Equipment not feasible for general clinical use:

Too Expensive

Too Cumbersome

Too Time consuming

Time to revisit SMR for Insomnia with Digital equipment and new training methods.

Pilot Study Overview: IRB approved 8/2008

Purpose –Compare treatment effects of Z score NFB SMR & sequential, quantitative EEG (sQEEG) guided

Individually Designed (IND) protocols for Rx of Insomnia.

Methods Eight completed single-blind study.

Intervention –Fifteen 20-minute sessions Z-Score NFB.

Pre-treatment Screening—Medical History Questionnaire

Psychiatric Diagnostic Screening Inventory (PDSQ) plus:

Pre-post measures –

Insomnia Severity Index (ISI)

Pittsburgh Sleep Quality Index (PSQI)

Psychopathology (MMPI-2-RF)

Clinical Interview

Satisfaction/Happiness Quality of Life Index (QOLI) sQEEG

PARTICIPANTS:

25+ Telephone Screening –unpaid, recruited over 4 months

Exclusions —use of sleep aids, psychotropic meds, meds that impact sleep, mental disorders, physical disorders that could interfere, prior NFB, enrolled in another sleep study, pregnant or shift worker

12 Selected/Met DSM 307.44 criteria

2 Declined to start due to personal/extraneous reasons

2 Dropped out due to personal/external reasons >8 visits

Enrolled & Randomized (n=12)

Treated (n=10)

Excluded (n=10)

Not meeting inclusion criteria (n=3)

Declined to continue (n-2)

SMR

Allocated to intervention

(n=6)

Did not receive allocated intervention

(n=1)

Give reasons

 Declined midway due to scheduling conflicts

Lost to follow-up (n=1)

Diqualified (n=1)

Discontinued (n=0)

Analyzed (n=5)

IND

Allocated to intervention

(n=4)

Did not receive allocated intervention

(n=1)

Give reasons

 Declined midway due to scheduling conflicts

Lost to follow-up (n=1)

Diqualified (n=1)

Discontinued (n=0)

Analyzed (n=3)

Figure 1. STUDY FLOW CHART

Sleep Measures

ISI= Insomnia Severity Index--Perceived Severity of

Symptoms + Daytime Dysfunctions for past 1-2weeks

PSQI=Pittsburgh Sleep Quality Inventory--General Sleep

Disturbance + Daytime Dysfunctions for past 1month

Daily Sleep Diaries=from Screening Visits to Post Testing-recordings of bedtime, rising time, estimated latency, WASO, TST, Sleep Quality 1-10, adverse events or unusual circumstances

Actiwatch=72 hours pre and post treatment

Measures of Daytime Functioning

MMPI-2 RFMost widely researched, used measure of psychopathology. Newest version

Psychiatric Diagnostic ScreeningQuestionnaire-

PDSQ—Guide to depth clinical interview to confirm absent Dx

Quality of Life Index-QOLI— Measures positive mental health=daytime function

Objective Physiological Measures sQEEG=Quantitative Electroencephalogram

Profiles the brain’s electrical functioning in direct comparison with normative database (NeuroGuide).

Like other direct physiological measures, such as blood sugar, lipids or liver enzymes, the EEG has demonstrated high reliability

ActiwatchNumerous technical difficulties invalidated use

sQEEG—EEG General Screening

Records several minutes at 4 scalp sites in 5 runs for total of 19 of 10/20 sites

Records overall synchrony measures between each set of 4 sites

BrainMaster Certified Calibration tested EEG amplifier for NFB/QEEG

NFB=Operant Conditioning to Norm

Training to Norm =Normalizing physiological process via self-regulating brainwave distribution

Based on Principles of Learning via Operant

Conditioning

Z-Score NFB designed to use Live, Instantaneous record as basis of Reinforcement

Experimental Groups

Group 1—Z-Score Individualized Protocol (IND) =

Normalized 4 highest abnormal site(s) (HAS4) via reward of correct enhancement or inhibition of variables > ±1.96 Z , at increasingly larger percentage of normal Z scores. Modified

PZOKUL.

Group 2—Z-Score SMR Protocol (SMR) =

Training at Cz and C4, LE, reward production of SMR (12-15Hz)

& inhibition of excessive theta & high beta, & all other amplitudes & connectivity measures within normal. Modified

PZOKUL .

General Training Procedure =

I nitial % of all variables in the normal range =50% raised as %

Time >80 Z scores normal. When % variables >80, Z score limit was reduced as far as possible.

Table 1. Demographics, Complaints, Global Sleep Scores

3

4

Subject

Number

1

2

Age Sex Duration Symptoms Group Pre

ISI

61 F Since

Childhood

WASO,WE SMR 18

50 F 1-5 Years WASO SMR 15

5

6

34

40

54

50

M

M

F

F

5 Years

1 Year

SOL,WASO SMR

SOL,WASO SMR

7 58 F Since

Childhood

SOL,WASO

,WE

8 50

Mean 49.63

M 10+ Years NS,WASO,

WE

IND

19

17

20+ Years WE,WASO,

SOL

IND 14

22+ Years WE,SOL IND 12

SMR 28

14

17.13

Pre

PSQI

14

11

17

16

9

11

17

12

13.38

Note: WASO =Wake after sleep onset WE =Wake too early SOL =Sleep onset latency

NS =Non-restorative sleep, SMR =Z-Score SMR Neurofeedback IND =sQEEG guided individualized Z-Score protocol. These Pre-treatment ISI and PSQI scores are comparable to those of insomnia patients in other insomnia studies with larger patient samples ( Sleep ,

2005). ISI score range=0-28, PSQI score range =0-21, cutoff >5.

Success of Training

All subjects reached training goal of 80% correct within normal range for 80% of the training time.

Four of 5 in SMR improved SMR Zscores (toward 0) at training sites

ANOVA

Age, sex, PDSQ, Group not significant covariates.

Groups combined for all measures.

Pre-Post Significant Changes

Significant improvement on all primary sleep measures. See Table 2 &

3, Figs 2 & 3

Sleep Efficiency above diagnostic cutoff Post treatment

WASO significantly improved in half.

QOLI significantly improved

MMPI clinical improvement sQEEG significant lowering of Delta (sleepiness) & Beta (arousal) Table 4

Six month Follow-up

Six of 8 responded

Five of 6 remained free of insomnia, one returned to baseline, 3 improved from baseline

Table 2. Primary Sleep and Quality of Life Measures

Measure

ISI

PRE MEAN- (95% CI)

17.13– [15.794,18.466]

POST MEAN- (95% CI)

6.56 - [5.901, 7.220]

F

18.2 p

< .005

PSQI-T 13.38 – [12.506, 14.254] 4.50 - [4.194, 4.806] 55.6 <.0001

PSQI-SE –[74.85, 80.43] –

[91.87,94.49]

15.8 <.007

QOLI 46.13

–[42.908, 49.352] 52.63– [49.827, 55.433] 9.6 < .02

Notes: ISI =Insomnia severity index PSQI-T =Pittsburgh sleep quality index - total PSQI-SE= Pittsburgh sleep quality index total - sleep efficiency QOLI= Quality of life index. All measures are based on the eight completers. Lower ISI and PSQI total scores are better. Higher QOLI and PSQI-SE scores are better. Significant post-treatment improvement on all measures.

Table 3. Post Treatment Change Summary

#/ Group #Rx

Δ WASO

Final %ZOK Increase SE%

1-SMR 15 -1 80 7.2

0

2-SMR 9 95 14.3

-2

3-SMR 13 86 27.1

4-SMR 15

-3

90 23

5-IND 15

0

85 8.7

0

6-IND 15 93 7

0

7-SMR 15 87 28.6

-2

8-IND 15 88 11.1

Mean 88% +15.88%

Increase TST

’’

75

60

90

60

0

30

120

+61.88 Min.

60

Table 4. Binomial tests of sQEEG Changes Pre to Post Treatment

18

16

14

12

10

8

6

4

2

0

Pittsburgh Sleep Quality Index (PSQI)

PSQI Pre

PSQI Post

SMR-2 SMR-3 SMR-4 IND-1 IND-2 SMR-5 IND-3

Figure 2: PSQI Pre-Post Change in Global Sleep Scores

Figure 3: ISI Pre-Post Change

Figure 4: TST Pre-Post Change in Total Sleep Time

Actiwatch—72 Hour data pre-post with Multiple

Technical Difficulties Prevented Analysis

• Click sound inaudible

• Possibly defective recording hardware

• Possibly defective recording software

• Vender suggested corrections via Sleep Log questionable

• User errors discovered too late to re-train

Adverse Events

None reported

__________________________

Two drop-outs

Unexpected life-style changes (trauma induced) interfering with treatment schedule

Conclusions:

1. Baseline EEGs showed both excessive sleepiness and hyperarousal, which significantly improved posttreatment.

2. Both NFB protocols provided significant improvement in self reported sleep, daytime functioning, mental health, and sQEEG.

3. SMR treatment at least as effective as IND, and significantly less burdensome to administer.

Discussion

1) Data replicates early SMR studies with new equipment and advanced software/training designs

2) Z score NFB possibly effective at 8 Rx sessions (160”) training time, possibly faster than traditional NFB & CBT

3) SMR at least as effective as Individually designed protocol based on sQEEG

4) Participants improved on ALL self-report sleep measures, quality of life, and mental health

Discussion ( continued)

5) All Participants became normal sleepers, relatively quickly

6) Safe, well-tolerated, non-pharmacological,

Non-Invasive

7) SMR easily practiced clinically

Limitations:

1) Small Sample Size

2) Regression toward Mean

3) Lack of Control group

4) Single Blind Design

5) Lack of useful Actiwatch/objective sleep measure

6) Lack of EEG connectivity measures in IND

I love sleep. My life has the tendency to fall apart when

I'm awake, you know?

Ernest Hemingway