A New Look at an Old Workhorse: Sensorimotor Neurofeedback

The authors wish to thank the Helfgott Research Institute of the National college of Natural Medicine for its support of this research, and William L. Gregory, Ph.D. for providing our statistical analysis. We appreciate of the generous time, energy, and support provided by our Research Assistants who helped in the development and conduct of the investigation: Sean E. Griffith of the Psychology Department at Duke University and Tineke Malus of the Natural College of Natural Medicine. This study was not supported by any industry funding.

2005 NIH Conference on Insomnia declared Insomnia an Epidemic:

10-20% of adults, mostly Women & Seniors, have Insomnia

Another 20-40% report sleep disturbances40% of children, especially those with other

vulnerabilities

National Sleep Foundation--November, 2009

•27% say their sleep has been disturbed at least a few nights a week in the past month due to personal financial concerns (16%), the U.S. economy (15%), and/or employment concerns (10%).

•54% of those losing sleep over economic concerns also had difficulty with their feelings at least a few days a week in the last month.

•People with sleep problems are sleeping less than 6 hours on a typical workday or weekday (35% vs. 14%); and/or

•They say they’ve driven drowsy at least once a month in the past year (41% vs. 23%).

Problems resulting from Insomnia are increasing

National Sleep Foundation 2009 poll:

Effects on Health and Daytime Funcitoning:

Compared to their better sleeping counterparts, these

people are more likely to report being unable to do the following because they are too sleepy:

o Work well and efficiently (25%)o Exercise (30%)o Eat healthy (22% )o Have sex (16% )o Engage in leisure activities (28% )

• Memory formation impairment=long-term memory impairment (Buzsaki,

Sept.,2009)

•Additional health care costs up to $14 billion (NSF)

•Sleepy drivers =major public safety problem & cost(NSF)

•Higher work place accident rates & lost productivity estimated $80 billion (NSF)

•Reduced immunity if Sleep Efficiency <92% (Cohen, Oct., 2009)

more Effects on Health:

October, 2009 (Cohen, 2009) found immunity to rhinovirus correlated with the amount of sleep in healthy adults.

1. Graded association with average sleepduration: participants with <7 hours of sleep were2.94 times (95% confidence interval [CI], 1.18-7.30) morelikely to develop a cold than those with 8 hours or moreof sleep.

2. The association with SE was alsograded: participants with less than 92% efficiency were 5.50times (95% CI, 2.08-14.48) more likely to develop a coldthan those with 98% or more efficiency

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 duration and:

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

Definition of Insomnia Most Widely Used

In Clinical Practice (American Board of Family Practice) and often in Research:

1)Sleep Latency (SOL) >30 minutes2)Sleep Efficiency (SE) <85%3)Sleep Disturbance >3 times a week

4)Research (Sleep, 2006, April: 29(4)) suggests cutoff of 20” is most sensitive and specific.

TREATMENTS:

Pharmaceuticals•Benzodiazepines most widely used, cannot use long term•Hypnotics can also cause Depression•Reports often hide drug harm (Lunesta, Rozerem)

CAM:•In 2007, 4.5% (1.6 million) of those surveyed used CAM treatments for Insomnia. Summary from NCCAM website November, 2009:

CAM

•Herbal products studied lack demonstrated evidence of effectiveness:

•Valerian, Melatonin, Chamomile, Kava, 5-HTP, & L-tryptophan (may be harmful, banned)

•Aromatherapy-some sleep inducing effects

Other CAM

•Acupuncture-inconclusive. New RCT shows promising results, from 270” electroacupuncture. Only slight but sign. difference pre

vs post Rx in SE from Diaries and from Actigraph. •Meditation, yoga-inconclusive. Just completed, unpublished RCT :

daily Kundalini, just prior to bedtime, 8 wks>sign. reductions in severity.•Relaxation techniques—EMG Biofeedback etc= mixed/inconclusive. Unpublished study showed SMR >EMG

Psychological treatments •highest co-morbidity• Insomnia persists despite psychotherapy for depression or anxiety•Physiological hyperarousal hypothesis-some support

• Cognitive Behavior Therapy—Demonstrated Efficacy•Sleep Restriction•Stimulus Control•difficult to administer•New Internet based program promising

1976, Hauri et al:

Waking SMR correlated +.64 with SE &-.64 with SOL

1981, Hauri et al:

Compared EMG & Theta & SMR biofeedbackOnly SMR significantly improved SleepTense Insomniacs benefited from Theta BFD

September, 2008 aapb:

Peter Hauri (Mayo Clinic): 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.”

This was the exact purpose of our study, which had been given IRB approval just the previous month-in August, 2008!

Overview:

Purpose –Compare effectiveness of SMR NFB and (a sequential, quantitative EEG) an EEG guided (IND) protocol for amelioration of Insomnia

Methods –RCT single-blind study.

Intervention –Groups received 15 20-minute sessions of Z-Score NFB.

Pre-post measures –Mental health (MMPI-2-RF and PDSQ), Quality of Life Index (QOLI), Insomnia Severity Index (ISI), Pittsburgh Sleep Quality Index (PSQI), sQEEG.

Neurofeedback Background & Rationale:

2 Primary Approaches Reflected in our 2 Groups

1. Symptom Based:Early SMROthmers’ 1980’s

2. 2-19 Channel QEEG/Brain Map Guided Lubar Walker Ayers

PARTICIPANTS: 20+ Telephone Screening –unpaid, recruited over 4 months

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

15 Passed Telephone Screening

12 Invited to enter study

2 Declined to start- personal/extraneous reasons

2 Dropped out- personal/external reasons ≤8 visits

Figure 1: Demographics, Complaints, & Scores

Age Sex Problems PreISI PostISI PrePSQI PosPSQI Duration Group

61 F WASO,WE 18 5 14 3 Childhood SMR62 F SOL,WASO,WE 28 7 17 5 Childhood SMR63 F WE,SOL 12 7.5 11 5 22+ yrs IND54 F WE,WASO,SOL 14 6 9 4 20+ yrs IND50 F WASO 15 9 11 5 1-5 yrs SMR49 M NS,WASO,WE 14 9 12 5 10+ yrs IND50 M SOL,WASO,WE 19 8 17 6 5 yrs SMR40 M SOL,WASO 17 1 16 3 1 yr SMR

Insomnia/Sleep Disturbance Cutoffs =8= ISI 5=PSQI

Pre Average: ISI= 17.13 PSQI= 13.38Post Average: ISI= 6.56 PSQI= 4.5

MEASURES continued

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

Actiwatch--Records movement/lack of movement. 3 days pre vs post. Multiple technical difficulties prevent use of data.

MEASURES continued

sQEEG—sequential EEG—EEG Screening

• Records several minutes at 4 scalp sites in succession in 5 runs

• Records connectivity measures between each set of 4 sites

• Certified Calibration tested EEG amplifier for NFB/sQEEG for FDA

METHODS:

NFB=Operant Conditioning to Norm

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

•Based on Principles of Learning via Reinforcement

•Need to monitor progress continually

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

Z Score NeurofeedbackPhysiological training toward Norm Z=0

Mean Std. Deviation NISI-PR Total

16.19 5.345 8

ISI-PO Total6.56 2.638 8

Insomnia Severity Index

•PR = pre, PO = post

•Age and Gender were not significant and did not interact with anything so dropped

•Pre to Post Change Test F(1,6) = 18.2, p < .005

Results

Group MeanStd.

Deviation NISI-PR Total IND

13.17 1.041 3

SMR18.00 6.205 5

Total 16.19 5.345 8

ISI-PO Total IND7.50 1.500 3

SMR6.00 3.162 5

Total 6.56 2.638 8

There is a hint of an interaction, p < .18, change differs between the treatment groups. The IND group does not change as much as the SMR group. It suggests IND is certainly not better than SMR, and it may be the other way around. 

MeanStd.

Deviation NPSQI-PR Total 13.75 3.495 8

PSQI-PO Total 4.50 1.225 8

PSQI

Pre to Post treatment Time change is sig, F(1,6) = 55.6, p < .0001.Covariates not significant

Group MeanStd.

Deviation NPSQI-PR Total

IND 10.67 1.528 3SMR 15.60 2.966 5Total 13.75 3.495 8

PSQI-PO Total

IND 4.50 .500 3SMR 4.50 1.581 5Total 4.50 1.225 8

PSQI

Time by group interaction is marginally significant, F(1,6) = 4.5, p < .08. SMR is better.

PSQI Sleep Efficiency

MeanStd.

Deviation NPSQI-PR SE 77.638 11.1530 8

PSQI-PO SMR 93.18 5.251 8

Pre to Post Change over time is sig, F(1,6) = 15.8, p < .007. Covariates not significant 

Group MeanStd.

Deviation NPSQI-PR SE

IND81.533 1.6623 3

SMR 75.300 14.0743 5

Total 77.638 11.1530 8

PSQI-PO SE

IND93.80 6.521 3

SMR 92.80 5.149 5

Total 93.18 5.251 8

PSQI Sleep Efficiency

No interaction with treatment. No treatment is better than the other.

QOLI:

MeanStd.

Deviation NQOLI-Pre Total

46.13 12.889 8

QOLI-PO Total 52.63 11.211 8

Pre to Post Time change is significant, F(1,6) = 9.6, p < .02. Covariates not significant

Group MeanStd.

Deviation NQOLI-PR Total

IND53.33 10.970 3

SMR41.80 12.969 5

Total 46.13 12.889 8

QOLI-PO Total

IND56.67 7.506 3

SMR 50.20 13.122 5

Total 52.63 11.211 8

Pre to Post Time by group interaction tends toward sig, p < .23. SMR slightly better.

QEEG

AbnormalWaves Pre Post         Significance     Delta          107 42 p<.001 Beta 54 33 p<.01 Hi Beta 21 17 p<.11

Delta:   Pre to post changes 107/304 vs 42/304 yields Z =6.0, p < .001, signif.Beta:  Pre to post 54/304 vs 33/304 yields Z = 2.6, p < .01, significantHi Beta: Pre to post not significant, p < .11, not significant

MMPI-2-RF: Pre vs PostChanges in Borderline Profile -004

Overall T score: Pre=54.11, Post=50.56. Three excessive Scale scores reduced to Normal: Demoralization, Dysfunctional Negative, Aberrant Ex

MMPI-2-RF: Pre vs PostChanges in Borderline Profile -010

Overall level Pre=73.3, Post=50.22 yielding >23 pt. reduction=very significant statistically & clinically

Actiwatch

Multiple Technical Difficulties Prevent Analysis

•Click sound inaudible•Possibly Defective recording hardware and software•Corrections of data with Sleep Log questionable•Participant errors•Processor errors

Summary of Results: •Total Scale scores Significant on both Insomnia Measures: ISI=p<.005, PSQI=p<.0001• PSQI Sleep Efficiency improved significantly p<.007•QOLI improved significantly <.02•Slight but not significant tendency for SMR to be better than IND. • Abnormally high levels of Delta and Beta power at Baseline p<.001•Delta and Beta power were significantly lowered post-treatment p<.001 Baseline HiBeta amplitude was not excessive.•MMPI-2-RF, borderline-normal subjects showed post-treatment clinical improvement.

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 and daytime functioning.

3.Some tendency for SMR treatment to be more effective than IND, and it was significantly less burdensome to administer.

4.No adverse events reported from full treatment

Discussion

1)Data replicates early SMR studies with new equipment and advanced software/training designs2)Z score NFB possibly effective after <15 Rx sessions (≤300”)3)SMR may be more effective than Individually designed protocol based on sQEEG4)All participants improved on ALL self-report sleep measures5)The power of Z Score SMR NFB suggest it could be very useful for the general Insomnia population

Discussion (continued)

5) sQEEG improvement demonstrates daytime physiological normalization

6) All subjects tolerated 9 weeks of Z Score NFB7) 15 sessions of NFB safe8) Non-Invasive, non-pharmacological9) SMR Easily replicated and practical for clinic use10) Robust effects11) QEEG or sQEEG may offer useful Biomarkers for

Insomnia