Neurofeedback for InsomniaA 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 DefinitionPrimary 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 ExpensiveToo 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

Figure 1. STUDY FLOW CHART

Excluded (n=10) Not meeting inclusion criteria (n=3)

Treated (n=10)

IND Allocated to intervention (n=4) Did not receive allocated intervention (n=1) Give reasons

Declined midway due to scheduling conflicts

SMR Allocated to intervention (n=6) Did not receive allocated intervention (n=1) Give reasons

Declined midway due to scheduling conflicts

Analyzed (n=3)

Lost to follow-up (n=1)

Diqualified (n=1)

Discontinued (n=0)

Lost to follow-up (n=1)

Diqualified (n=1)

Discontinued (n=0)

Analyzed (n=5)

Enrolled & Randomized (n=12)

Assessed for eligibility Assessed for eligibility (n=25)

Declined to continue (n-2)

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 RF-Most widely researched, used measure of psychopathology. Newest version

Psychiatric Diagnostic Screening-Questionnaire-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

Actiwatch-Numerous 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 processvia 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 =Initial % 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

Subject Number

Age Sex Duration Symptoms Group Pre ISI

Pre PSQI

1 61 F Since Childhood

WASO,WE SMR 18 14

2 50 F 1-5 Years WASO SMR 15 11

3 34 M 5 Years SOL,WASO SMR 19 17

4 40 M 1 Year SOL,WASO SMR 17 16

5 54 F 20+ Years WE,WASO,SOL

IND 14 9

6 50 F 22+ Years WE,SOL IND 12 11

7 58 F Since Childhood

SOL,WASO,WE

SMR 28 17

8 50 M 10+ Years NS,WASO,WE

IND 14 12

Mean 49.63 17.13 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 Z-scores (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

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.

Measure PRE MEAN- (95% CI) POST MEAN- (95% CI) F p

ISI 17.13–[15.794,18.466] 6.56 - [5.901, 7.220] 18.2 <.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

Table 3. Post Treatment Change Summary

#/Group #Rx Δ WASO Final %ZOK Increase SE% Increase TST’’ 1-SMR 15 -1 80 7.2 75

2-SMR 9 0

95 14.3 60

3-SMR 13 -2

86 27.1 90

4-SMR 15 -3 90 23 60

5-IND 15 0 85 8.7 0

6-IND 15 0

93 7 30

7-SMR 15 0

87 28.6 120

8-IND 15 -2

88 11.1 60

Mean

88% +15.88% +61.88 Min.

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

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

Pittsburgh Sleep Quality Index (PSQI)

02468

1012141618

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

Participant

PS

QI T

ota

l Sco

rePSQI PrePSQI Post

1/SMR 2/SMR 3/SMR 4/SMR 5/IND 6/IND 7/SMR 8/IND

Subject Number/Group

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 post-treatment.

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 Size2) Regression toward Mean3) Lack of Control group4) Single Blind Design5) Lack of useful Actiwatch/objective sleep measure6) 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