Description of the (Clinical Outcomes) Study:

1. The LENS(Low Energy Neurofeedback System):A Clinical Outcomes Study on One Hundred Patientsat Stone Mountain Center, NYCollected over five years of practice (since 1999)Principal Investigators:Stephen Larsen, Ph.D. AIBT, BCIA-eegand Kristen Harrington, M.A. AIBTwith Robin Larsen, Ph.D., Susan Hicks, mathematical statisticianResearch Assistants: Jodie Schultz, MA, AIBTAlexandra Linardakis, BA, AIBTand Tara Johannesen, BAPresented at the Annual Meeting of the International Society for Neuronal Regulation (ISNR) Denver Colorado, September 2005

2. Description of the (Clinical Outcomes) Study: • Clients selected by blinded researchers from extensive files: Criteria were completeness of records and adequate numbers of sessions. • Men and Women evenly distributed (49/51). • Study was done on 100 clients at Stone Mountain Center who received the LENS for at least 10 sessions. • Ages range from 6-80.

3. Description Continued • Clinical Data was taken at each LENS (neurofeedback) session, the LENS being understood by both client and therapist as the only treatment we were systematically tracking. • Five Symptom Areas which impaired “quality of life” were tracked for each client.

4. Description (cont’d): • No effort was made to separate easy from difficult clients. Both were included. • Many clients (according to the referral sources) in “more difficult to treat” category, had tried the gamut of other therapeutic modalities. A More Complex Course An “Easy Course of Treatment

5. DSM IV-r Related Diagnostic Categories Represented in Study • ADD, ADHD, attentional problems of all sorts, Learning Disabilities • Affective Disorders including Monopolar and Bipolar Depression, Dysthymia • Autistic Spectrum Disorders, including Aspergers Syndrome • Anorexia and Bulimia • Dissociation • Epilepsy and Seizure disorder • Explosive Personality Disorder, Oppositional-Defiance • Fibromyalgia, Chronic Fatigue, Lyme Diseas, Epstein-Barr syndrome • High Blood Pressure • Headaches (Cluster, Tension and Migraine) • Irritable Bowel, Ulcerative Collitis • Obsessive Compulsive Disorder • Pain, both Acute and Chronic or both, Muscle Spasms, Dystonia • Paranoia and Schizophrenia • Post Traumatic Stress Disorder (PTSD) • Tourettes, and Tic Disorders • Traumatic Brain and Spinal Injury (TBI)

6. From Our Sample Largest group received 20 treatments

7. Hypotheses: • That the LENS treatment improves quality of life for patients across a spectrum of symptom or distress areas. • That improvement (drop in scores) is greater in the earliest sessions, but continues throughout treatment. • That there is a relationship between change in subjective scoresand change in amplitude of the highest, or “worst” site. • That there is a relationship between change in subjective scores and change in the amplitude at CZ. (an arbitrarily chosen site, sometimes used in neurofeedback treatments, correlates more poorly with improvement than the HAS (highest amplitude site).

8. Data Manipulation and Analysis: • Data entry was done by Volunteers, from our secured archives of patient files. All staff and volunteers were acquainted with HIPAA regulations, and signed agreement forms to respect privacy of patient information. • Clients remained unknown to data processors. • The only criterion was that the client have an initial LENS map and at least 10 sessions. We selected, out of about three hundred files, the first hundred that met our criteria.

9. Data Manipulation and Analysis: • Data was then sent to an independent Statistician for analysis (Susan Hicks). • Results were then sent back to principal investigators (Stephen Larsen and Kristen Harrington) for final analysis and presentation.

10. The Neurofeedback Modality: • The LENS of Dr. Len Ochs is a feedback/stimulation modality conceived during the early 1990’s. Names have morphed with the understanding of the method: • Initially ILT (Interactive Light Therapy); • EEF (EEG Entrainment Feedback; • EDF (EEG Distentrainment Therapy); • EDS (EEG Disentrainment Stimulation); • FNS, Flexyx Neurofeedback System; • and now settled on the LENS (the Low Energy Neurofeedback System). • First used with light and sound, then light only, through LED’s, then masked LED light, then only radio waves as a carrier for the feedback.

11. The Modality: • Lawrence Livermore Labs subjected the equipment to minute scrutiny in 1998, finding that… • Radio Emissions from Crystal Clock are in the 15-100mHz band, and with an intensity of 10-18 Watts/Sq.cm. (Lo-stim is 10-21).

12. The Equipment: • J&J I-330 C2 or mini-C2 EEG processors • Software is Ochslabs proprietary adaptations of J&J’s USE 2 or USE 3 software. • Maps and Offsets were processed on Ochslabs Report Generator. • All treatment followed an initial brain map of 21 or 19 sites, and in most cases, used an offset established by the Offset procedure. • Treatment times and intensities were varied to conform with the sensitivity of the patient, from as little as one second per treatment, up to a maximum of about 21 seconds of treatment. Average was about 1 treatment per week.

13. Len Ochs, PhD.,is a Clinical Psychologist Trained in Biofeedback who developed the LENS. “We don’t want to substitute our “good idea” of what the brain ought to be doing for allowing it to regulate itself, and monitoring the effects of what we do, to see if the patient is changing within the bounds of comfort.” (Jacob in a LENS session)

14. Understanding EEG-Driven Stimulationor Low Energy Neurofeedback • The subject/patient’s own EEG drives the feedback. • Feedback follows the actual brainwave (dominant frequency) usually at an “offset.” • This is a Passive, Not Active ,Feedback Procedure. Client “does” nothing. • Training is Extremely Gentle: Clinical Comfort of Client is foremost.

15. History: • (Clearly pleased client) • In the early days of Interactive Light Therapy ILT, welder’s goggles and earphones were used.

16. Clinician Carrie Chapman at Stone Mountain Center, giving FNS, using more svelte, sexy dark glasses with LED’s with Mabel Larsen, age 99

17. In current usage no goggles are needed (Dizzy doesn’t like goggles anyway)

18. Topic Two • An Offset:Stimulation Frequency Tracks Dominant Frequency 20Hz higher (Originally designed to prevent seizures). • Stimulation Itself is a fraction of the whole time the C2 is tracking the Brainwave--only a second or two. The rest is lo-stim condition. • With the most sensitive clients, even lo-stim seems to have a treatment effect.

19. An Offset Protocol: Consists of a total of six minutes of “baseline,” and four one second stim periods at +5,10,15 or 20; usually recorded at FZ (frontal). Six minute baseline allows clinician to watch live brainwave Four minute visual Image of events following each offset with RMS line for Alpha and Delta

20. The LENS Includes obligatory visits to all 19 siteson the International 10-20 map (a USE 3 screen)

21. Enough of this horseplay!

22. (MB) acute onset agoraphobia after 9/11:Area Chart, patient’s subjective rating, six primary symptoms over 20 sessions.

23. 31 32 33 34 35 36 37 38 39 40 1/24/2003 1/31/2003 2/28/2003 3/14/2003 3/22/2003 4/11/2003 5/30/2003 6/6/2003 6/13/2003 6/20/2003 4.0 3.5 5.0 3.0 3.0 4.0 5.0 4.0 4.0 4.0 1.5 1.5 3.0 3.0 1.5 3.0 2.0 1.0 1.0 1.0 4.0 3.0 5.0 4.0 4.0 6.0 5.0 4.0 3.0 2.0 6.0 5.0 6.0 5.0 5.0 6.0 7.0 5.0 4.0 3.0 6.0 5.0 5.0 5.0 5.0 6.0 7.0 5.0 5.0 4.0 7.0 6.0 5.0 4.0 4.0 4.0 4.0 3.0 3.0 2.0 Ginny: Subjective Symptom Rating Chart 40 sessions from first treatment.

24. Subjective Symptom Rating Scale over 20 sessions 10/01 to 6/02 (Ginny)Note the decrease in headache score dramatically lower than mood, energy and cognitive measures

25. Subjective Symptom Categories: • 1) Addiction: Alcohol, Drugs, Cravings, Food, Sex • 2)Anxiety Problem: Generalized anxiety, Hypervigilance, Panic, Phobia, Startle • 3) Behavior Problem: Annoying. Disruptive, Impulsive • 4) Cognitive Problem: Cognitive Prob. Cloudiness, Confusion, Cognitive Deficit • 5)Executive Functions: Impaired-Planning, Sequencing, Organizing, Prioritizing • 6) Disorganization: Organization Problem, Procrastination, Disorganized • 7) Dissociation: Detached, Withdrawn, Passive, Dissociated • 8) Attention: Problem Focussing, ADD, ADHD, Distracted • 9) Flexibility Problem: Impaired flexibility, Creativity, Multiprocessing, Rigidity, OCD • 10) Mood Disturbance: Bi-Polarity, Depression, Dysthymia, Explosiveness, Irritability • 11) Pain: Back or Neck, Other, Headache, Migraine, Muscle Spasm, TMJ • 12) Somatic Problem: Collitis, Food Issues, Anorexia, Bulimia, Irritable Bowel, High Blood Presure • 13) Sleep Disturbance: Insomnia, Early awakening, Restless Leg Syndrome • 14) Miscellaneous: Seizure,Tics, Hallucinations, Psychosis • 15) Fatigue: Lack of Energy, Motivation, Fibromyalgia, Chronic Fatigue

27. Scatter Plots for Sample Symptom Categories

28. Scatter Plots for Sample Symptom Categories

31. Total Change in SSR Scores

32. Change in EEG Amplitude at CZ over Course of Treatment 10.67 9.62

33. Change in Amplitude at Highest Site over Course of Treatment 17.38 10.87

34. Change in amplitudes in μV at CZ (on L) and Highest Amplitude Site (on R)

36. Changes in Subjective Symptoms Correlate with Changes in EEG

37. Words from Our Statistician, Susan Hicks: • These results are a statisticians dream! • Most symptom areas achieve significance below the .0001 level That means that there is overwhelming evidence that the results are showing a true difference. • The lowering of EEG amplitudes at both CZ (smaller difference) and HAS (greater difference) are both highly significant.

38. For Further Information: www.stonemountaincenter.com (845-658-8083) www.ochslabs.com See forthcoming book: The Healing Power of Neurofeedback: The Revolutionary LENS Method for Optimizing Brain Function (Healing Arts Press, Feb 2006) by Stephen Larsen, PhD.