Cranial Electrotherapy Stimulation: Treating the Brain with Electrons for Pain and Stress-Related Disorders

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1 Cranial Electrotherapy Stimulation: Treating the Brain with Electrons for Pain and Stress-Related Disorders Daniel L. Kirsch, PhD, DAAPM, FAIS Years of Experience in Electromedicine Chairman, Electromedical Products International, Inc. Former Clinical Director of the Center for Pain & Stress-Related Disorders of Columbia-Presbyterian Medical Center at the College of Physicians and Surgeons of Columbia University of the City of New York Diplomate, American Academy of Pain Management Fellow, American Institute of Stress Member, International Society for Neuronal Regulation Consulting Editor, Journal of Neurotherapy Electromedicine Dept. Editor, Practical Pain Management Honorary Member, Inter-Pain (Germany/Switzerland) Member, Presidents Council, University of North Texas Pain, Stress and PTSD Consultant to US Army and VA 6 Dr. Daniel L. Kirsch, Mineral Wells, Texas, USA, Telephone: 1-8-FOR-PAIN Cranial Electrotherapy Stimulation (CES) Easy -Step Procedure: 1. Wet Electrodes. Place on Ear Lobes. Turn on CES Device. Set to Comfortable Current for Minutes to One Hour The application of low level current, (usually <1 ma) applied across the head for medical or psychological conditions, or just as an aid in relaxation FDA authorized by Rx for anxiety, depression and insomnia Also used for fibromyalgia, ADD/ADHD, PTSD, CRPS (RSD), phantom limb pain, other pain syndromes Qualitative Results What to Expect from CES Most people report feeling: Happier, Their Bodies are More Relaxed, Their Minds are More Alert, and They Feel Younger, More Energetic Dr. Saul H. Rosenthal Psychiatrist and CES Researcher Reported: Calm, Relaxed Sensation Activation of Alertness Euphoric Tranquility Not Worrying Bright and Happy Increased Energy Improved Sleep No Confusion, Memory Loss or Disorientation Dr. Saul H. Rosenthal Typical Comments from Patients: As if I have been given a happy pill. Sort of a floaty, smiley feeling, very pleasant. This is quite a change of moods. Anxiety about capability seems reduced. Smiling for no reason. As though I have almost been conditioned not to worry. Although I feel depressed, it is nothing like I would expect from past experience, even though the problem is large. 1

2 Michael Hutchison Author of the book Megabrain Wrote: My body immediately felt heavier, as if I was sinking down into myself. [Then] I realized I was becoming extremely relaxed....things are very, very clear. My body was no longer heavy, but very light, full of energy. The feeling was one of openness, clarity, as though I had been wearing sunglasses for weeks and had suddenly taken them off. I couldn t help but feel that this is the way we re supposed to be all the time. Proposed Mechanisms of Actions of CES James Giordano, PhD Georgetown University Regulation of Mood and Emotional Lability Decreased Arousal/ Agitation Prefrontal Cortex CES Fronto- Tempoparietal Cortex Amygdala Hypothalamus -HT Raphe Nuclei Change in Sensory Processing Thalamus NE LC ACh LDT/PPN Analgesia EEG Alpha Rhythm QEEG Changes in Subjects Treated with Minutes of CES. There is an Increase in Alpha and a Decrease in Delta Activity. Blue = decrease Red = increase Courtesy of Richard Kennerly, University of North Texas Ph.D. dissertation Adverse Effects from CES From 16 human studies encompassing 6,7 people with,1 receiving active CES treatment: 9 myogenic headaches (.%, 1:6) cases of skin irritation (.11%, 1:91) These are mild and self- limiting. Primary Contraindications Embryofetal Effects on Rats Little and Patterson, fetal rats had 1 hour/daily CES throughout their pregnancy at 1, 1, or 1, Hz, 1 volt, 1 µa via ear tag electrodes. Autopsy revealed no congenital anomalies. More pregnancy resorptions and fewer offspring in all groups, but only significant in the 1, Hz group. Average fetal weight and brain weight were inversely proportional to frequency. Behavior resembled CES in humans, even in this aggressive species; treated rats were not as active as the controls, so the decrease in fetal weights may be because their food intake was lowered. Conclusion: CES may be embryolethal in the very early stages of pregnancy and might cause some miscarriages, but there is no evidence of fetotoxic effects.

3 Tracey Kirsch did CES throughout both pregnancies (Mrs. Kirsch at 9+) Topics of Scientific Research on CES Sasha Kirsch at months! Gabrielle Electra Kirsch at ½ years CES is FDA approved for anxiety, depression, and insomnia Number of Pivotal Scientific Studies: Anxiety + 1 Phobia 6 Depression 7 Insomnia 1 stress Topics of Scientific Research on CES for brain functions attention deficit disorder (ADD) cerebral palsy closed head injuries 9 cognitive dysfunction learning and memory reaction time, vigilance Number of Pivotal Scientific Studies: pain anesthesia dental fibromyalgia headaches 8 muscle tone/ movement/tremor 1 pain 1 rehabilitation and other applications bronchial asthma 1 gastric acidity 1 labor sex offenders suggestibility Research Methodology of 86 Pivotal (out of 16) Studies of CES Double-Blind Placebo-Controlled 9 Single-Blind 1 Controlled Study 6 Crossover Open Clinical Trial Retrospective Study Case Study 1 Follow-up Beta-endorphins 98% in plasma 19% in CSF Serotonin 1 % in plasma % in CSF From research by neurosurgeon C. Norman Shealy, MD Electromyogram (EMG): with recovery to normal in 1 minutes in Mm spasticity in pts with hemiplegia and paraplegia frontalis Mm maintained 1 week post treatment relaxation involuntary movements in pts with Parkinson s and dystonia musculorum were changed during treatment and eventually completely eliminated 1.8 µv to. 8 µv to. 1. µv to.8 8. µv to.

4 Experimental Animal Studies on CES Rat studies showed as much as a threefold increase in β-endorphin concentration after just one CES treatment (Krupisky, 1991). Blind tests of tail-flick latency (TFL) in rats show a significant increase in analgesic effect of opiates. (Stinus, 199). TFL as a % of baseline with drug, and with drug plus CES: morphine fentanyl alfentanil dextromoramide Drug Alone 17% 176% 16% 67% Drug Plus CES 6% 6% 1% 9% Results were also obtained after intracerebroventricular injection of morphine (1 micrograms; analgesic effect increase from 1% to 7% with CES) suggesting that CES potentiation of opiateinduced analgesia is centrally mediated. The Use of CES to Potentiate Anesthesia in Surgery Amount of Anesthetic Required Fentanyl N O % N O 6.% Anesthetic Used Anesthesia Plus CES Anesthesia Alone N O 7% Studies Percentile on Depression Scale Norms The Effects of 7 to 1 Days of CES Treatment on Depression Studies 8 After CES Treatment Before CES Treatment Zung Depression Scale Percentile on Depression Scale Norms The Effects of and Weeks of CES Treatments on Depression Studies After CES Treatment Before CES Treatment POMS Depression Scale CES Review: A Safer Alternative to Psychopharmaceuticals in the Treatment of Depression Marshall Gilula, MD and Daniel L. Kirsch, PhD Journal of Neurotherapy, 9(): downloadable at Over Placebo Prozac Studies Paxil 1 Studies Zoloft Effexor Studies 6 Studies Treatment Serzone 8 Studies CES 8 Studies CES is x more efficacious than the average SSRI Anxiety Scores Before and After CES Treatment Percentile on Anxiety Scale Norm Tension/Anxiety - POMS Taylor Manifest Anxiety Scale State Anxiety - STAI Trait Anxiety - STAI Anxiety Test Used Post Test Pre Test Studies

5 Number of Scale Points of Improvement Muscle Tension Change in Stress Measures From a Single CES Treatment Muscle Tension Controls Pulse Pulse Controls Temperature Stress Measure Heffernan, 199 Temperature Controls Visual Analogue Scale Anxiety Score 6 1 Situational Anxiety in Dentistry Following Real or Sham CES Treatment Alpha-Stim Treated Sham Treated Pre Treatment Phase Post Winick, 1999 Percent Increase in Relaxation Response of 8 Horses Following minutes of Alpha-Stim Treatment Clark, Mills and Marchant, Heart Rate, 17% Standing Alert, % Dozing, 8% Shaking Head, 6% Vocalizing, % Ear Flicking, % Response of Insomnia Patients to CES Seep Onset Latency % Bed Time Awake Stage One Sleep CES Treatment CES Rx Follow-up Sham Treated Sham Rx Follow-Up Delta, Stage IV Sleep Sleep Characteristic Measured Weiss, 197 Felt Very Rested in AM Two Meta-Analyses Reconfirmed the Significance of CES Research for Treating Anxiety: University of Tulsa (O Connor, Presented at the 1 th annual meeting of the Bioelectromagnetics Society, 1991) Department of Health Policy and Management, Harvard School of Public Health (Klawansky, et al, Journal of Nervous and Mental Disease 18(7):78-8, 199) Both Found CES Significantly Effective for Anxiety (P<.) Meta-Analyses of the Treatment Effects of CES Kirsch et al. -- Chapter in Bioelectromagnetic Medicine, chapter downloadable at r Effect Size Weighted for N of Subjects in Each Study Anxiety N=8 (1,761) Depression N= (1,7) Insomnia N=1 (9) Cognitive N=1 (777) Addiction N=16 (8) Trait Analyzed - Number of Studies (and Subjects)

6 1 1 Attention Deficit Disorder (ADD) Depression State Anxiety Trait Anxiety Verbal I.Q. Performance I.Q. Full Scale I.Q. Smith, 1999 Post Treatment Self Rated Pain Level Patient Response to 1st and nd Minute CES Pain Treatments, N = 17 Pre 1st Post 1st Post nd Emotional and Cognitive Tests May Help with Fibro-Fog Initial Self Rated Pain Level Results Achieved with CES Based on a Physician Survey of Patients No Slight Fair Moderate Marked Complete Significant Condition N Worse Change <% -9% -7% 7-99% 1% >% Pain % 1.7% 6.99% 16.78% 6.9% 7.76% 9.% 9.91% Anxiety %.9%.1% 11.17%.% 1.86%.16% 9.7% Depression %.%.98% 16.8%.6%.7% 7.61% 89.67% Stress %.%.6% 1.9% 7.% 7.88%.86% 9.% Insomnia % 11.8% 8.89% 1.9%.19%.% 8.1% 79.6% Headache %.%.97% 16.6% 1.19% 1.7% 1.6% 9.7% Muscle Tension.77%.%.% 16.% 9.%.86% 6.18% 9.9% Depression: 7% >% or % >7% improved Pain: 7% >% or 7% >7% improved (Average pain reduction from opioid use is %) Results Achieved with CES Technology Based on a Survey of Patients Reporting Psychological Disorders Condition N* Slight <% Fair -9% Moderate -7% Marked 7-1% Significant >% Psychological (all cases) %.%.78%.8% 91.6% Anxiety (alone) %.66%.81%.8% 89.8% Anxiety (with other) %.97%.97%.1% 91.8% Anxiety/Depression %.76%.76% 9.1% 9.8% Depression (alone) %.7%.%.6% 86.79% Depression (with other) %.%.9%.9% 89.6% Stress %.9% 1.71% 9.% 9.1% Chronic Fatigue % 6.%.% 1.% 9.% Insomnia % 8.8% 8.8% 6.% 9.87% *Total N = patients with multiple symptoms. Results of those using Alpha-Stim at least weeks before mailing warranty card. Warranty cards are consecutive cards received as of July. Depression: 66% >% or - 1% >7% improved Results Achieved with CES Technology Based on a Survey of, Patients Condition N* Slight <% Fair -9% Moderate -7% Marked 7-1% Significant >% Pain (all cases) % 1.97% 8.%.% 9.% Back Pain % 7.% 8.96% 9.% 9.% Cervical Pain % 6.% 7.17%.% 9.1% Hip/Leg/Foot Pain % 6.88%.1% 6.% 96.% Shoulder/Arm/Hand Pain % 7.%.%.% 91.% Carpal Tunnel 17.%.% 68.% 1.% 1.% Arthritis Pain % 7.1% 6.81%.1% 9.1% *Total N = patients with multiple symptoms. Results of those using Alpha-Stim at least weeks before mailing warranty card. Warranty cards are consecutive cards received as of July. Pain: 61% >% improved Results Achieved with CES Technology Based on a Survey of, Patients (continued) Condition N* Slight <% Fair -9% Moderate -7% Marked 7-1% Significant >% TMJ Pain % 7.97% 7.97% 1.9% 89.% Myofascial Pain % 9.% 9.%.6% 9.% RSD % 9.9%.% 18.18% 81.8% Fibromyalgia 1 19 (alone) 1 9.1% 7.% 6.6% 16.9% 9.8% Fibromyalgia (with other) 6 9.9% 6.9% 1.87% 1.9% 9.91% Migraine % 1.%.% 1.6% 98.1% Headaches (all other) % 6.79% 1.%.9% 8.1% *Total N = patients with multiple symptoms. Results of those using Alpha-Stim at least weeks before mailing warranty card. Warranty cards are consecutive cards received as of July. Fibromyalgia: % - >% improved 6

7 Changes in Fibromyalgia Patients Following Weeks of CES Treatment Tyers, 1 (N=19) Change in Mood Scores of Fibromyalgia Patients Following CES Treatment Tyers, 1 (N=19) Tender Points Self Rated Pain Self Rated Sleep Feeling of Well Being Function Measured Quality Of Life Anxiety Depression Anger Lack of Vigor Fatigue Confusion TMD Mood Factor Measured CES Double- Blind Fibromyalgia Study Rheumatology Lichtbroun et al. 1 (N=6) Response of Patients on Various Measures 1 Alpha-Stim CES Open Clinical CES 8 Sham Treatment Placebo Controls CES Double- Blind Fibromyalgia Study Rheumatology Lichtbroun et al. 1 (N=6) Fig. Change in Mood Scores of Fibromyalgia Patients Follwing Alpha-Stim CES Treatment - - Tender Point Pain Self Rated Pain Sleep Felling of Quality of Life Total Mood Well Being Disturbance Anxiety Depression Anger Lack of Vigor Fatigue Confusion TMD M ood Factor M easured Factor Measured Change in Fibromyalgia Tender Point Pain Scores from Pre to Post Study Lichtbroun et al., 1 (N=6) CES Double- Blind Fibromyalgia Study Rheumatology Lichtbroun et al. 1 (N=6) Sleep Pattern of Study Groups 7 Little or No Sleep Moderate Sleep 6 Good, Very Restful Sleep Sham Treatment Placebo Controls Alpha-Stim CES Post Study Treated Controls Pre Study Sham Rx Subsensation CES Sensate CES Group Reporting 7

8 CES Double-Blind Fibromyalgia Study LSU Dept of Anesthesiology Pain Intensity (-) Cork et al. (N = 7) CES Double-Blind Fibromyalgia Study LSU Dept of Anesthesiology Tenderpoint Score Cork et al. (N = 7) 1 ** * ** 8 * 1 Sham Group *p<.1 between Groups **p<.1 from Baseline Sham Group *p<.1 between Groups **p<.1 from Baseline Baseline Weeks 6 Weeks Mean±Standard Error Double-Blind Sham/CES Crossover Baseline Weeks 6 Weeks Mean±Standard Error Double-Blind Sham/CES Crossover CES Double-Blind Fibromyalgia Study LSU Dept of Anesthesiology McGill Score Cork et al. (N = 7) CES Double-Blind Fibromyalgia Study LSU Dept of Anesthesiology POMS Score Cork et al. (N = 7) 1 8 ** ** 6 * 1 Sham Group **p<.1 from Baseline Sham Group *p<.1 between Groups **p<.1 from Baseline Baseline Weeks 6 Weeks Mean±Standard Error Double-Blind Sham/CES Crossover Baseline Weeks 6 Weeks Mean±Standard Error Double-Blind Sham/CES Crossover CES Double-Blind Fibromyalgia Study LSU Dept of Anesthesiology VA Houston Spinal Cord Injury CES Study Oswestry Score Cork et al. (N = 7) 1 1 Sham Group Baseline Weeks 6 Weeks Mean±Standard Error Double-Blind Sham/CES Crossover 8

9 VA Houston Spinal Cord Injury CES Study Before and After Session Pain Ratings Treatment Group (n = 18) Before and After Session Pain Ratings Sham Group and Their Open Label Treatment (n = 17) Day Before Session After Session Sham Before Session Day Before and After Session Pain Ratings Sham Group (n = ) Open Label After Session Day Before Session Tan at al., 6 After Session Figures 1,, and : Daily Pain Rating for Active CES and Sham s Accumulated Migraine Headaches -- Frequency x Intensity Brotman, Biofeedback Alone Biofeedback Plus CES Following 8 Treatments After 1 Month After Months After Months Time After Treatment Began Example of the CES Response in a Patient with Severe Migraine Courtesy of COL Michael Singer, Walter Reed Army Medical Center The Response of Multiple Sclerosis Patients after Weeks of CES 6 PAIN 1 1 minutes hours 1 So, stay with it! TIME Right Hand Left Hand Pain Fatigue Sensory Vision Spasticity Function Measured Improvement in RSD Symptoms and Function Following CES Treatment Alpher and Kirsch, First Author Year Brotman, Philip 1986 Brovar, A. 198 Comments on Follow-up from CES Research Studies FROM PIVOTAL SCIENTIFIC STUDIES: N 6 Subject Description classical migraine pts cocaine abusers Authors Comments on Follow-up CES group responded significantly better than the other groups over the month follow-up. No CES patients had returned for treatment, while % of the CES refusers and 9% of the controls recidivated in 6 to 8 months. 1 Pain Relief Sleep Improvement Working Hours Anxiety Depression Symptom Rated Headaches Muscle Tension Flemenbaum, A. 197 Hearst, E.D anxiety, depression, insomnia outpatients unresponsive to medication psychotherapy outpatients Those who had beneficial results maintained them throughout the 6 month follow-up. patients showed continued improvement for weeks to months. 9

10 Heffernan, Michael 199 Magora, F Matteson, Michael 1986 Moore, J.A. 197 A: B: generalized stress pts >1 year, unresponsive to medication A: anxiety, depression, insomnia hospitalized polysubstance abusers, and B: asthmatic children unresponsive to medication CES graduate students, controls anxiety and insomnia pts 1 week follow-up measures in the CES group showed significant carryover effects in EMG and HR A: Follow-up has continued for 8-1 months after treatment and has revealed no relapse. B: The asthmatic attacks stopped completely in children and months later the children felt well without taking any drugs. A follow-up measure weeks post study found that 11 of the 1 variables were still significantly improved in the treatment group. a remarkable improvement in their symptoms - weeks after CES. Overcash, Stephen 1999 Patterson, M. 198 Smith, Ray 1999 Weiss, Marc anxiety outpatients hospitalized alcohol and polysubstance abusers psychiatric outpatients with anxiety, depression, ADD insomnia patients On 6-8 month follow-up, 7% of the patients were well satisfied with their treatment and had no significant regression or other anxiety disorder. 78.% were addiction-free (8.% of drug addicts) 1 to 8 years after CES, with an average time in rehabilitation of only 16 days. On 18 month follow-up the patients performed as well or better than in the original study. All differences found were maintained at the week and year follow-up. Cumulative Cost of Treatment Comparison of Anti-Depressant Drugs with Alpha-Stim SCS (at $9) CES First Year $, $1, $1, $ Breakeven is at to 6 Months $ Month 1 M onth Month M onth Month M onth 6 Month 7 M onth 8 Month 9 Month 1 Month 11 Month 1 Paxil $8 $ 167 $ $ $16 $ $8 $ 666 $7 $ 8 $916 $ 999 Prozac $17 $ 7 $1 $ 6 $68 $ 8 $96 $ 1,9 $1, $ 1,66 $1, $ 1,69 Zoloft $11 $ 9 $ $ 8 $7 $ 687 $8 $916 $1,1 $ 1,16 $1,6 $ 1,7 Alpha-Stim SCS $9 $ 97 $ $ $7 $ $6 $ 7 $8 $ 86 $88 $ 61 Month Savings Cumulative Year Savings Using CES Instead of Drugs -Year Device Warranty and Assuming No Drug Price Increases $8, $7, $6, $, $, $, $, $1, $ Year 1 Year Year Year Year AS vs. Paxil $8 $1,6 $,1 $,1 $,899 AS vs. Prozac $1, $, $,6 $,81 $7,99 AS vs. Zoloft $76 $,1 $,68 $, $,77 Year Are Your Patients in Pain? Having Difficulty Sleeping? Depressed? Anxious? Stressed? Why Not Try CES? Questions? dan@epii.com 1