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Depression
1. Bianco, Faust. The efficacy of cranial electrotherapy stimulation (CES) for the relief of anxiety and depression among polysubstance abusers in chemical dependency treatment. Ph.D. dissertation, The University of Tulsa, 1994.
Device: LB 2000, 100 Hz, 2mS, <1.5 mA, electrodes behind the ears at the mastoid process
Prior to clinical trials the literature of CES for chemical dependency was subjected to meta-analysis. Initially 180 studies on CES from 1964 through 1987 were reviewed. 8 studies provided the necessary information to calculate means and standard deviations for meta-analysis. The largest effect sizes pertained to the primary withdrawal symptoms of drug use, drug craving, and anxiety specifically among methodone users. In addition the results showed effect sizes beyond that of a placebo effect in several studies relating to anxiety as a secondary withdrawal symptom. However, some studies that considered anxiety as a secondary withdrawal symptom were below the placebo effect level. The analysis displayed an average effect size of 0.940 SD units when comparing CES plus a standard treatment to a CES sham plus a standard treatment, and an effect size of 1.68 when comparing CES plus a standard treatment to standard treatments alone. The average effect sizes for the within groups studies were 0.534 SD units for CES treatments (P<.10), 0.391 SD units for CES sham treatment plus the standard treatment (P<..05) and, 0.171 SD units for the standard treatment alone. The range of the effect sizes for the within group studies were between 0.25 and 0.83 units. The authors concluded that the statistical significance of the within group analysis is quite impressive. To put this into perspective, the average effect size of all psychotherapies are between 0.70 and 0.80 SD units when compared to no treatment (roughly 75% of the pts who receive psychotherapy improve in their condition relative to controls who receive no therapy). The average effect size for non-specific factors or placebo effects among psychotherapies as compared to wait-list controls is about 0.40 SD units.
After achieving IRB approval and informed consent, 65 polysubstance abusers with no history of psychosis were recruited from the Oklahoma Department of Human Services and split into 3 groups for this double-blind study using blinding boxes. Pts were at a lock-in unit at the Chemical Dependency Unit. 36 subjects (18 CES, 16 controls, and 5 sham CES) left AMA. 20 males and 9 females from 20 to 49 years old (mean of 31.3) completed the full course of 45 minutes daily for 6 - 14 days. 9 pts in group 1 (31%) were non-CES controls receiving standard treatment, 9 pts (31%) in group 2 received simulated CES plus standard treatment, 11 pts (38%) received active CES plus standard treatment. The revised Beck Anxiety and Depression Inventories, and the Symptom Check List of the Himmelsbach Scale were administered, along with an attention placebo control interview, and observer-rated measures employed by 2 researchers: the Structured Interview Guide for the Hamilton Anxiety and Depression Scales. In order to achieve a power of .8 (beta = .2), alpha was calculated at .05, effect size at .60, and N at 30 (10 per group). Scheffe tests were performed to determine the significance between the means of each of the 3 groups. There was no significant difference between variables at pretest. Analysis of variance (ANOVA) revealed significant post test group differences. Hamilton Anxiety means for CES pretest was 24.44 9.22 to a post test of 7.09 3.21, for sham CES pretest was 22.56 9.95 and post test was 15.67 7.92, and for controls pretest was 20.56 6.21 and posttest was 16.89 9.06. Scheffe post hoc tests for Hamilton was significant between the CES and controls (P<.05) and between the CES and sham (P<.05), but not the sham and control (P>.05) as measured by the observer ratings. Beck Anxiety post test means were not significant, means for CES pretest was 22.91 10.99 to a post test of 5.27 5.23, for sham CES pretest was 28.78 15.21 and post test was 9.33 7.97, and for controls pretest was 21.44 9.89 and posttest was 9.78 12.17. Although the self reports showed no statistical differences between groups, there was a trend towards significance. The study did not control for medications. The author concluded that the active CES, when combined with the normal treatment regimen given at the treatment facilities was more effective in reducing anxiety and depression than the normal treatment regimen alone and the sham CES plus normal treatment regimen. Thus, the anticipated results regarding CES was supported, while the anticipated results regarding placebo effect was not supported. No side effects were reported.
3. Briones, David F. and Rosenthal, Saul H. Changes in urinary free catecholamine and 17ketosteroids with cerebral electrotherapy (electrosleep). Diseases of the Nervous System. 34:57-58, 1973.
Device: 100 Hz, 1 mS, positive pulses, cathodes over orbits, anodes over mastoids
7 male pts from 22 to 37 years old were given 30 min. of CES for 5 days. 4 were "normal" volunteers and 3 were hospitalized psychiatric pts with neurotic anxiety and depression. 1 alcoholic was dropped because his pre-treatment reading was far outside the range of normal of the other pts. Total free catecholamines were measured by bio-rad column (normal is 0 - 115 microgram per 24 hours) prior to and after 5 CES treatments. Pre and Posttesting means revealed a 23.9 to 47.4 microgram increase in 24 hour urinary free catecholamine across all patients, with the greatest rise in 2 anxiety pts and 1 volunteer who was slightly symptomatic. The average gain in 24 hour urinary 17 ketosteroids was 6.9 mgs, pretreatment mean was 18.5 and post treatment was 25.4 (normal is 10 to 24 mgs per 24 hours). 2 pts had insignificantly reduced levels. The authors suggested that these findings probably reflected change at the hypothalamic or pituitary level in the brain. No side effects were reported.
7. Cox, Aris and Heath, Robert G. Neurotone therapy: A preliminary report of its effect on electrical activity of forebrain structures. Diseases of the Nervous System. 36:245-247, 1975.
Device: Neurotone, 100 Hz, 2 mS, 500 µA
A 41 year old female pt with history of severe depressive disorder was prepared with deep and surface electrodes for long-term brain study. She was given 2, 30 min. CES sessions with a crossover treatment/simulated treatment design, followed by prepost EEG readings. After actual but not simulated treatment, pt reported feeling drowsy and relaxed, and she remained in this relaxed state for about 30 minutes, after which she went to sleep for an hour. This was unusual for her. After the pt awakened, her relaxed state lasted 3 hours. There was also a welldeveloped alpha rhythm in the occipital cortex following actual but not simulated treatment, also unusual for her. Since she was not considered suggestible (several attempts at hypnotism to relieve her symptoms had been unsuccessful), the authors concluded, "electrosleep therapy has a demonstrable physiologic effect in contrast to some published reports that it is only suggestive." No side effects were reported.
11. Feighner, John P., Brown, Stuart L., and Olivier, J.Edward. Electrosleep therapy: A controlled double blind study. Journal of Nervous and Mental Disease. 157:121128, 1973.
Device: Electrosone 50: 100 Hz, 1 mS, 100 - 250 µA, cathodes over orbits, anodes over mastoids
23 long term psychiatric pts who had been ill a minimum of 2 years with prominent anxiety, depression, and insomnia, and who did not respond to psychotherapy, psychopharmacology, and ECT in 4 cases, were given 2 weeks of CES and 2 weeks of sham CES in a double-blind crossover design. Treatments were for 30 minutes daily, Monday through Friday. Analyses were done by the 2-tailed Mann-Whitney U test. Scores on the Zung self rating depression scale improved significantly in both groups, but only after 10 days of active treatment, and never during the sham phase of treatment. Actively treated pts also improved significantly on other target symptoms, particularly anxiety and insomnia. The CES-sham group means based on global ratings of anxiety was 4.5 on day 1, 2.5 on day 15 (P<.02), and 3.4 on day 26 (P<.10), and the sham-CES group was 4.4 on day 1, 4.0 on day 15 (not significant), and 3.2 on day 26 (P<.05). 7 of 8 pts who exhibited significant improvement relapsed within the first month after treatment. 4 of 6 long term depressed pts were dropped from the study because of massive worsening of depressive symptoms, 2 of whom exhibited suicidal ideation. The remaining 2 depressed pts had an unremarkable course, but remained in the study. 3 pts benefited more from this therapy than any previous extensive psychiatric care. No side effects were reported.
19. Hearst, E.D., Cloninger, R., Crews, E.L. and Cadoret, R.J. Electrosleep therapy: A doubleblind trial. Archives of General Psychiatry. 30:46366, 1974.
Device, Neurotone 101, 100 Hz, 2 mS, alternating and direct current, forehead to mastoid electrodes
28 psychiatric outpatients on medication and undergoing psychotherapy were divided into 4 groups, 22 received CES treatments or sham treatments using alternating current, and 6 more were divided into an alternating or direct current, or sham treatment group. A total of 14 received actual CES. All had 5, 30 minute treatments or sham treatments. Assessment was by the National Institute of Mental Health self rating scale (SRSS) and by physician and pt global ratings for sleep, anxiety, depression, and overall status. The groups did not differ substantially in the number of days they were symptomatic following treatment. However, the pts receiving active treatment were confirmed by Fisher's exact test for 2 x 2 contingency tables to be significantly (P<.05) less depressed than the sham group (79% vs. 21%). Other positive findings showed a trend (P<.10) towards improvements in the CES group over the sham in feeling lonely (64% vs. 21%), having feelings easily hurt (64% vs. 21%), and difficulty falling or staying asleep (71% vs. 29%). Physicians and pts global ratings showed an insignificant tendency towards improvement on the last day of treatment. There was no significant differences between the groups 2 weeks post treatment, and only 2 pts continued improvement, 1 relapsed after 1 month, while another relapsed in 2 months. A third pt showed marked improvement for 1 week, relapsed for 3 weeks, then responded again to biweekly treatments for 2 months. All 3 pts with sustained improvement had active treatment. Self rating scales did not indicate a significant improvement for anxiety, insomnia, or somatic complaints. No pt with primary affective disorder was adversely affected by CES. The authors concluded that either CES may transiently increase the pts tolerance of their depressive symptoms without significantly altering symptom frequency, or that it has a transient mild effect on both symptom frequency and intensity without any appreciable change on the natural course of the illness. There was no report of side effects.
21. Henderson, James L., Church, Dixie Jane, and Lee, A. Using electrosleep therapy with university counseling center clients: A preliminary study. Paper presented at both the Southeastern Psychological Association, February, 1973 and the Rocky Mountain Psychological Association, May, 1973.
45 university students were referred to the student counseling center with various anxietytype complaints. The study was completed with historical controls only. Pts were treated with CES an average of 14 days. Significant changes were found on the MMPI, Zung depression scale, Diagnostic Adjective Check List (DACL), systolic and diastolic blood pressure and pulse rates. Abstract courtesy of Ray B. Smith, Ph.D., M.P.A.
26. Krupitsky, E.M., Burakov, G.B., Karandashova, JaS., et al. The administration of transcranial electric treatment for affective disturbances therapy in alcoholic patients. Drug and Alcohol Dependence, 27:1-6, 1991.
Device: 70 - 80 Hz, 4 - 7 mA, square waves, cathodes on forehead, anodes behind ears
20 alcoholic pts with affective disorders who volunteered were equally divided by chance into 2 groups for this double-blind, placebo controlled study. All pts were abstinent for at least 3 weeks, so their affective disturbances were not alcohol withdrawal syndrome (AWS) symptoms. They were all weakly or moderately depressed, and exhibited a high level of reactive and personal anxiety. The CES group (N = 10) had 20 treatments over a 4 week period, and the placebo group (N = 10) were given a weak current, but otherwise the same conditions. There was considerable improvement in the CES group on the MMPI depression scale and Zung's test. Reactive anxiety of the active CES group by Spielberger (pre test mean of 51.7 3.14 to post test 30.6 2.15, P<.05), Personal anxiety by Speilberger (pre test mean of 51.4 3.09 to post test 13.8 5.15, P<.05), and anxiety by Taylor's scale (pre test mean of 26.6 1.79 to post test 14.0 3.63, P<.01) were all reliably diminished. The placebo group demonstrated a tendency toward a definite aggravation of the state and some increase of affective disturbance on all tests: Spielberger reactive anxiety (pre test mean of 51.7 2.81 to post test 63.0 3.44, P<.05), personal anxiety (pre test mean of 66.9 2.71 to post test 51.2 4.93), Taylor anxiety (pre test mean of 20.5 1.99 to post test 28.0 3.21). The activity of MAO-B in blood platelets and GABA concentration in blood were increased in the CES group after 20 treatments. The concentration of serotonin, dopamine, and -endorphin in blood were not substantially changed. The changes of biochemical indices were not registered in the control group where the tendency towards decreased MAO-B and GABA level in blood corresponded with a definite increase of affective disturbances at the end of the course. EEG analysis showed that the latency of -rhythm appearance in occipital leads after closing eyes were decreased after CES, whereas in the control group it was practically not changed and considerably exceeded the indices of the CES group. The CES pts became more tranquil, well-balanced, active, and their mood was improved. The authors concluded that CES is an effective non-pharmacological method to treat affective disturbances (depression, anxieties) in alcoholic pts in remission. They also stated that CES was not accompanied by side effects nor complications and was well tolerated by the pts, and that CES tends to avoid side effects and complications sometimes observed in antidepressant therapy and tranquilizers.
27. Levitt, Eugene A., James, Norman McI, and Flavell, Philippa. A clinical trial of electrosleep therapy with a psychiatric inpatient sample. Australia and New Zealand Journal of Psychiatry. 9:287290, 1975.
Device: Dormed: 100 Hz, 50 - 200 µA, square pulses, cathodes over orbits, anodes over mastoids
This is a double-blind study of 13 chronically distressed pts, 6 male and 7 female, 23 - 63 years old, in an inpatient psychiatric hospital (length of stay, 2 months to 16 years). All were on antidepressant and/or tranquilizing medication, with 9 on sleep medication. They were diagnosed with schizophrenia (N = 4), alcoholism (N = 2), psychotic depression (N = 2), and mixed neurosis and disorders of personality (N = 5). 5 received CES treatment and 6 received simulated treatment for 10 sessions over 2 weeks, 30 minutes per session. Instrument malfunction made it impossible to complete the treatment program with 2 active CES pts. There were no significant changes between groups on the Taylor Manifest Anxiety Scale or the Zung SelfRating Depression Scale. Clinician ratings of anxiety and insomnia were "found to agree to an extremely limited extent" with results on the anxiety and depression scales. 4 of 5 of the active CES pts showed a decrease on Taylor, while the 5th remained constant, for an average drop of 4.4. 5 pts improved with placebo while the remaining 1 got worse, an average drop of 3.2. Therapist ratings of anxiety showed 2 pts to be improved, 2 unchanged, and 1 worse following active CES. Of those receiving sham treatment, 1 was rated improved, 2 unchanged, and 3 more anxious. The Zung depression scores for 2 CES pts showed improvement while the other 3 showed an increase. 5 of 6 sham pts showed a decrease in depression, and 1 was more depressed. Clinician ratings of depression noted improvement in 3, no change in 1, and increased depression in 1 receiving active CES, while 3 sham CES pts improved, and 3 were unchanged. The authors noted that since nightly sedatives were administered the fact of a nonsignificant increase in sleep was hardly surprising. Subjects in both groups reported slight blurring of vision lasting 30 to 45 minutes following treatments. This supports the findings of other researchers that the blurred vision effect is mechanically caused by pressure of eye electrodes, and not electrical current.
30. Madden, Richard, and Kirsch, Daniel, Lowintensity electrostimulation improves human learning. American Journal of Electromedicine. 4(2):41-45, 1987. Also doctoral dissertation (RM), City University Los Angeles, 1987.
Device: Alpha-Stim 350, 0.5 Hz, 50% duty cycle, 200 µA, biphasic rectangular waves, ear clip electrodes
103 normal, healthy volunteer subjects without typing skills, responded to recruitment efforts, 21 failed to satisfy the inclusion criteria or declined to participate. Of the remaining 82, 4 did not show up. 78 (29 males and 49 females) completed this double blind study. They were randomly assigned to receive either 1, 20 minute Alpha-Stim CES treatment session (N = 39), or sham treatment (N = 39). The performance measuring device was a computer game called MasterType designed to teach typing skills, while measuring speed and accuracy. A baseline trial was conducted without stimulation. Immediately following the first trial, the subjects received real or sham CES and began the second trial. A total of 4 trials were completed by all subjects. Performance products (PP's) were obtained by multiplying rate per minute and accuracy scores following the completion of each trial. Prestimulation means of the first 2 trials were calculated as PPt1 (performance product for the first trial). PPt2 represented poststimulation or sham stimulation. The dependent variable was the performance gain score computed by taking the difference between t1 and 12 performance products represented as PG = PPt2 - PPt1. All t-tests were employed at the 0.01 confidence level. CES subjects improved significantly on the computer task involving psychomotor cognitive skills, with a PP4 - PP2 PG mean of 5.6 2.2, while 12 (30.8%) of the sham patients actually experienced a decrement in performance, and none improved significantly: PP4 - PP2 PG mean of 0.7 2.3. The authors concluded that this study demonstrates the efficacy of CES in improving human learning and performance. Normal or learning disabled children might also be taught more efficiently under the immediate or residual effects of CES in classroom settings. Others seeking increased alertness, concentration, and performance may also benefit, such as police officers, automobile drivers, air traffic controllers, surgeons, pilots, and athletes. No side effects were reported.
31. Magora, F., Beller, A., Assael, M.I., Askenazi, A. Some aspects of electrical sleep and its therapeutic value. In Wageneder, F.M. and St. Schuy (Eds). Electrotherapeutic Sleep and Electroanaesthesia. Excerpta Medica Foundation, International Congress Series No. 136. Amsterdam, Pages 129-135, 1967.
Device: 30 - 40 Hz, 2 mS, 2 mA, forehead to occipital fossa electrodes
20 hospitalized pts suffering from long-lasting insomnia with anxiety, obsessive and compulsive reactions, morphine and barbiturate addiction and involutional depression were given 2 - 4 CES treatments weekly for 2 - 3 hours a day for a total of 10 - 20 treatments. 5 of the 20 showed no improvement, 11 had sedative effects, and 4 had hypnotic effects. The 15 responders all had normal restoration of their sleep rhythm as measured by EEG. Parallel with the return to a normal sleep pattern, all the other psychiatric signs: anxiety, depression, agitation, delusions, abstinence syndrome, improved so that all these pts were able to leave the hospital. Follow-up has continued for 8 - 12 months after treatment and has revealed no relapse.
Also 9 children (aged 5 - 15 years) suffering from severe, long-lasting bronchial asthma, resistant to conventional treatment, including steroids, were given 3 - 24 (Av. 15) CES treatments once a week for 1 - 2 hours. The asthmatic attacks stopped completely in 3 children and 4 months later the children felt well without taking any drugs. 2 children showed objective improvement, no wheezes were found on examination and, the frequency and severity of wheezing spells were diminished. 1 child showed slight improvement, 2 did not respond at all. None suffered an asthmatic attack for 24 hours following CES. Placebo conditions did not cause any improvement. The authors concluded that it appears that CES may be an adjunct to the treatment of asthma in children. Because of the selection for trial of the most severe cases available to us, resistant to any other known treatment, even slight results are encouraging. It was also noted that no ill-effects were noted on prolonged and repeated observations in dogs and in humans.
34. Marshall, Alan G. and Izard, Carrol E. Cerebral electrotherapeutic treatment of depressions. Journal of Consulting and Clinical Psychology. 42(l):9397, 1974.
Device: 100 Hz, 1 mS, 0.5 - 1.5 mA, cathodes over orbits, anodes over mastoids
40 depressive inpatient volunteers without a chronic psychotic history (30 females and 10 males, aged 25 - 70 years) from a state psychiatric hospital were given 30 minute CES treatments for 5 successive days while on a regular hospital regimen. All of the pts were taking medication, part of the effect of which was usually sedative. Both active CES (N = 20), and simulated CES controls (N = 20) improved significantly on the DES+D II modification of Izard's Differential Emotion Scale. Heart rate, blood pressure and sleep records were also maintained, but they were largely invalidated by sources of variability associated with hospital routine. Note: The first author made the CES device used in this study and reports that although no pts were burned, he and 1 pilot subject suffered seconddegree burns behind one ear at the point of electrode contact. The 2 burned controls took almost 3 times the amount of current as the pts (1.4 mA over 0.5 mA average). Such burns are virtually unheard of among commercially manufactured CES units.
37. Moore, J.A., Mellor, C.S. Standage, K.F., and Strong, H. A doubleblind study of electrosleep for anxiety and insomnia. Biological Psychiatry. L0(l):5963, 1975.
Device: Neurotone, 100 Hz, 2 mS, mean of 480 µA
17 persistent anxiety and insomnia pts (21 - 60 years old, mean of 37.7), without evidence of psychosis, were given 5, 30 minute CES treatments or simulated treatments in a crossover design after providing informed consent. The pts were told not to make any changes in their medication. There was improvement in all measures but one during the first week, but no significant difference between groups on the Taylor Manifest Anxiety Scale, Beck's Depression Inventory, or Eysenck's Lie, Neuroticism, or Extraversion scales, except that subjective insomnia improvement (P<.05) was noted during active treatment. The mean change in ratings over the first week for clinical anxiety was 0.62 for active CES and .61 for sham, for subjective anxiety was 0.37 for active and 0.55 for sham, and on Taylor was -0.75 for active and 2.55 for sham. Over the second week for clinical anxiety the mean was 0.27 for active CES and 0.31 for sham, for subjective anxiety was 0.00 for active and 0.88 for sham, and on Taylor was 1.87 for active and 2.25 for sham. The authors concluded that five, 30 minute sessions might not be sufficient to elicit the effects studied. Also the current was unusually low for the device used. Curiously, the authors noted up front, in the abstract, that despite largely negative findings, several subjects reported a remarkable improvement in their symptoms some 2 - 3 weeks after CES. Note: While this is called doubleblind, only the patients, and not the therapist were blind to treatment conditions. No side effects were reported.
41. Passini, Frank G., Watson, Charles G., and Herder, Joseph. The effects of cerebral electric therapy (electrosleep) on anxiety, depression, and hostility in psychiatric patients. Journal of Nervous and Mental Disease. 163(4):263266, 1976.
Device: Neurotone 101, 100 Hz, 2 mS, cathodes over orbits, anodes over mastoids
60 inpatient volunteers (59 males, 1 female) in a V.A. hospital suffering from either anxiety or depression were randomly assigned to CES treatments or simulated treatments. The diagnoses included alcohol addiction, depressive neurosis, manic-depression, anxiety neurosis, drug dependence, organic brain syndrome, schizophrenia, psychotic depressive reaction, hypochondriacal neurosis, hysterical neurosis, adult adjustment reaction, social maladjustment, acute alcohol intoxication, personality disorder, passive-aggressive personality, and situational disturbance. Both groups were given 10, 30 minute treatments. All subjects in both groups improved significantly (P<.001) on the Multiple Affect Adjective Check List (for anxiety, active CES means was 12.06 pre test to 8.67 post test, for placebo CES 11.47 to 7.90) and on both the State Scale of the STAI (active: 64.93 to 45.20, placebo: 52.17 to 44.10) and Trait Scale of the STAI (active: 52.10 to 46.67, placebo: 50.47 to 43.77). The authors noted that no attempt was made to control the amount or type of psychotropic medication administered to the patients and most of the subjects on the study were on psychoactive drugs. No side effects were reported.
42. Philip, P., Demotes-Mainard, J., Bourgeois, M. and Vincent, J.D. Efficiency of transcranial electrostimulation on anxiety and insomnia symptoms during a washout period in depressed patients; a double-blind study. Biological psychiatry. 29:451-456, 1991.
Device: Diastim: 350 Hz, 0.7 mS, 1 - 1.2 mA, rectangular monophasic pulses, cathodes over orbits, anodes over mastoids
21 psychiatric inpatients suffering major depressive disorders according to DSM III-R criteria were divided into 2 groups for this double-blind study. The active CES group (N = 10) had 3 males and 7 females (age 44.9 10.3) with an average length of depressive illness of 56 months (1 - 156). The placebo group (N = 11) had 3 males and 8 females (age 36.4 13.8) with an average length of depressive illness of 64 months (5 - 222). All patients completed informed consent. The treatment withdrawn upon admission consisted of benzodiazepines (9 of 10 active and 8 of 11 placebo), barbituates (1 of 10 active), antidepressant drugs (5 of 10 active and 8 of 11 placebo), and neuroleptics (1 of 10 active and 1 of 11 placebo). The study began on the first drug-free day. Depressive pathology was evaluated daily by the Montgomery and Asberg Depression Rating Scale (MADRS). Sleep was evaluated using a sleep diary and questionnaire. Analogic self-rating scales evaluated anxiety, fatigue, arousal, and life events. Student's paired t-test was used to analyze the data. During the 5 day washout period, the natural development of symptoms consists of a rise in anxiety and an exacerbation of sleep disorders. In 2 cases, benzodiazepine withdrawal induced epileptic seizures in pts devoid of epileptic history. These seizures did not occur during CES sessions. The depressive criteria in the CES group paralleled that in the placebo group. Anxiety and sleep criteria showed divergent changes between groups. Anxiety on MADRS was exacerbated in the placebo group but reduced in the CES group (P<.01). The same was true of the ninth criteria of MADRS, pessimism about the future and feelings of guilt and failure. There was no other significant changes on MADRS in either group. Sleep duration improved in the CES treatment group, but was significantly worsened in the placebo group (P<.05). Feelings of fatigue and alertness revealed a positive change in the CES group (P<.05), but not in the placebo group. The authors concluded that the effects of a drug washout period are markedly attenuated by cerebral electrostimulation, which is of possible interest in the management of psychotropic drug withdrawal. No side effects were reported.
44. Rosenthal, Saul H. Electrosleep: A doubleblind clinical study. Biological Psychiatry. 4(2):179185, 1972.
Device, 100 Hz, 1mS, 0.5 - 1.2 mA, orbit to mastoid electrodes.
22 neurotic and personality disorder pts (including 2 inpatients) with anxiety, depression, and insomnia (20 females, 2 males 26 - 63 years old, mean = 43.1 years) were divided into active (N = 11), or sham groups (N = 11), each given 5, 30 minute treatments in a double-blind design. A 1 - 7 clinical rating scale was used by a psychiatrist before the first and after the final treatment for 3 areas of symptomatology: anxiety, sleep disturbance, and depression. The Zung depression scale was also employed at the same times. Pts receiving active treatment had a marked clinical improvement over pts receiving placebo treatment. Of the 11 CES pts, 8 showed a marked improvement, 2 showed a partial improvement, and 1 showed no improvement. Of the placebo group, 1 showed marked improvement, 2 showed partial improvement, and 8 showed no improvement. Average "total clinical ratings" on anxiety, sleep disturbance, and depression fell from 11.3 before CES treatment to 3.2 following treatment. The placebo group only fell from 12.2 to 9.5. In anxiety, the CES group fell from 4.3 to 1.4 while the placebo group only fell from 4.4 to 3.2. 8 of the pts who had sham treatments were then given real CES. Pts receiving active treatment following inactive treatment responded better than pts receiving inactive treatment, but did not respond as well as those who received active treatment first. For example, the anxiety score fell from 4.0 to 2.5. At the end of the CES treatment, pts felt no confusion, memory loss, or disorientation. They usually reported a calm, relaxed sensation during the treatment, and a feeling of sedation with a desire to sleep following the treatment. The author stated that he can not help being a little skeptical at his own results. He added that no treatment in common experience is as effective with this type of pt as these results indicate. No side effects were reported.
46. Rosenthal, Saul H., and Wulfsohn, Norman L. Electrosleep: A preliminary communication. Journal of Nervous and Mental Disease. 151(2):146151, 1970.
Device: Electrosone 50: 100 Hz, 1 mS, 0.5 - 1 mA, cathodes over orbits, anodes over mastoids
10 chronic anxiety, depression, and insomnia pts (25 - 65 years old) unresponsive to medication were selected from a psychiatric "medication clinic" and given from 7 to 10, 10 - 30 minute CES treatments. 6 completed the course of therapy, 4 dropped out because of inability to afford transportation to the clinic, medical illness, recovery after 1 treatment, and "not liking" the treatment. An additional 3 psychotically depressed inpatients were treated for a total N of 9. Of the 6 outpatients, 5 had relatively total remission, and 1 was a treatment failure. Of the 3 inpatients, 2 were treatment failures and 1 had partial improvement. The average score overall for the 9 pts for sleep disturbance fell from 5.8 to 2.9, while the anxiety rating fell from 5.7 to 3.0. The clinical depression rating fell from 5.8 to 3.6 and the Zung Depression Scale scores fell from an average of 62.7 to 44.8. The 5 responders were all females with an average age of 47.6. Their sleep disturbances fell from 5.6 to 1.0 (no sleep disturbance), anxiety fell from 6.0 to 2.0, depression fell from 5.6 to 1.4 with Zung score falling from 60.4 to 29.2. 3 pts reported discontinuing sleeping pills that they had been taking for months or years. There was no side effects reported in any of the pts other than a transient blurring of vision reported by several of the pts, probably associated with the forced closure of the eyes by the eyepads for 1 hour, which cleared within 15 - 30 minutes after treatment.
47. Rosenthal, Saul H. and Wulfsohn, Norman L. Studies of electrosleep with active and simulated treatment. Current Therapeutic Research. 12(3):126130, 1970.
Device: Electrosone 50: 100 Hz, 1 mS, 100 - 250 µA, cathodes over orbits, anodes over mastoids
12 psychiatric outpatients, unresponsive to medications, were selected from an outpatient medication clinic. All were suffering from chronic anxiety, depression, and insomnia. They were given from 5 to 10 CES treatments (12 pts received 10 treatments). They were evaluated before treatment on a 1 - 7 (7 = severe) scale and Zung Self-Rating Scale and reevaluated after 5 sessions. 9 of the 12 pts had relatively total remission of their symptoms, 2 were treatment failures, and 1 was considered to show partial improvement. Overall, the average rating for sleep disturbance fell from 5.8 to 2.3, anxiety fell from 5.9 to 2.7, depression dropped from 5.2 to 2.3 and the average score on the Zung scale fell from 57.4 to 36.3. Following the 5 treatments, 8 of 12 were completely asymptomatic with regard to insomnia. 6 pts selected in the same way were given simulated CES treatments on a single-blind basis. 2 of the 6 remained unchanged. 4 showed partial improvement. None showed the dramatic complete remission that was seen with active CES treatment. The average rating on the anxiety scale for the sham group fell from 4.7 to 4.3, sleep disturbance fell from 6.0 to 4.0, depression fell from 4.8 to 3.7 and the average rating on the Zung scale fell from 55.8 to 46.8. The authors noted that the only side effect was a transient blurring of vision, reported by several of the pts, which cleared within 15 minutes after treatment. It was probably due to the forced closure of the eyes and the pressure of the eye pads. It was seen less often with later pts, and this may be due to less tight placement of the electrodes. The authors concluded that somewhat to their surprise, 9 of 12 pts showed marked responses to treatment.
54. Shealy, C.N., Cady, R.K., Wilkie, R.G., Cox, R, Liss, S, and Clossen, W. Depression; a diagnostic, neurochemical profile & therapy with cranial electrical stimulation (CES). Journal of Neurological and Orthopaedic Medicine and Surgery. 10(4):319321, 1989.
Device: Liss Pain Suppressor
14 non-smoking adults (6 males, 8 females, 22 - 72 years old) with no known illness served as Group 1 controls. Group 2 were 14 intractable chronic pain pts (5 males, 9 females, 30 - 68 years old). Group 3 were 9 chronic pain pts considered by themselves to be hopeless (3 males, 6 females, 32 - 60 years old). Group 4 were 11 pts with longstanding depression of more than 2 years unresponsive to 2 or more antidepressant drugs (3 males, 8 females, 30 - 67 years old). Fasting blood levels of serotonin, -endorphin, norepinephrine, and cholinesterase were taken, along with the Zung test for depression, before and 2 weeks after CES, given for 20 minutes each day. In the depressed patients there was a significant elevation of serotonin (mean of 33.18 9.33 pretest to 44.64 9.10 post test P<.0089) and a significant decrease in cholinesterase (mean of 13.82 2.86 pretest to 10.45 3.04 post test P<.0067). There was a clinical lifting of depression in 60% of depressed pts and an improvement in pain complaints in 44% of the pain pts. The authors concluded that CES may be of therapeutic value in depression and in chronic pain. No side effects were reported.
60. Smith, Ray B., McCusker, Charles F., Jones, Ruth G., and Goates, Delbert T. The use of cranial electrotherapy stimulation in the treatment of stress related attention deficit disorder, with an eighteen month follow up. Unpublished, 1991 and follow-up in 1993.
Devices: Alpha-Stim CS, CES Labs, Liss Stimulator (randomly assigned)
This study compared the effects of 3 randomly assigned CES devices which had marked differences in electrical stimulation parameters, in the treatment of stress related attention deficit disorder in 23 children and adults, 9 males, 14 females, 9 - 56 years old (average 30.96) with an average education level of 10.56 years. All had been diagnosed as having generalized anxiety disorder (61%), and/or depression (45%), and/or dysthymia (17%). 8 had a primary diagnosis of ADD. CES treatments were given daily, 45 minutes per day for 3 weeks. All 3 CES devices were equally effective based on Duncan's Range test in significantly (P<.001) reducing depression as measured on the IPAT depression scale (mean of 19.38 8.44 pretest to 13.19 7.00 post test), state and trait anxiety scales of the STAI (mean state anxiety was reduced from 39.95 11.78 pretest to 29.76 6.99 post test, and the mean trait anxiety was reduced from 43.90 11.31 pretest to 32.19 7.50 post test), and in increasing the Verbal pretest (mean of 99.38 13.20 to post test of 107.50 14.13), Performance (mean of 107.4 15.05 to 126.6 14.2 ), and Full Scale I.Q. scores on the WISC-R or WAIS-R IQ tests (mean of 103.2 13.7 to 117.6 14.28). The authors concluded that in the unlikely event that our findings are the results of placebo effect alone, a CES device, retailing at approximately $795, would still be a relatively inexpensive and apparently reliable treatment for such a debilitating disorder as stress related ADD. On 18 month follow up, the pts performed as well or better than in the original study, the Full Scale IQ had not moved significantly from where it was after the first 3 weeks of treatment, the Performance IQ fell back slightly, while the Verbal IQ continued to increase. There did not seem to be any pattern of addiction to or over dependence on the CES device. There was no side effects except for 1 pt who cried during treatments, and 1 who was sore behind the ears when the electrode gel began drying out.
61. Smith, Ray B., O'Neill, Lois. Electrosleep in the management of alcoholism. Biological Psychiatry. l0(6):675680, 1975.
Device: Neurotone 101, 100 Hz, 2mS, <1.5 mA, frontal and occipital electrodes
72 male alcoholic inpatients (average age of 42.4, average drinking of 22 years with an average of 5 years of heavy drinking) were given either CES (N = 24 at end of study) or simulated CES (N = 23 at end of study), 40 minutes a day for 15 days. All pts were also receiving medication and psychotherapy. Norms were derived from 342 inpatient alcoholics. The CES group improved significantly (beyond the 0.001 level of confidence) on all 5 negative subscales of the Profile of Mood States while the control group improved on only 2 subscales: Tension-Anxiety and Depression-Dejection. The mean scores were: Tension-Anxiety (pretest active CES mean of 12.61 1.39 to 6.30 0.79 post, control pretest 12.22 1.37 to 6.43 0.95 post), Depression-Dejection (pretest active CES mean of 12.32 1.73 to 4.52 0.87 post, control pretest 12.80 1.79 to 6.80 1.56 post), Anger-Hostility (pretest active CES mean of 6.75 1.41 to 1.21 0.42 post, control pretest 6.63 1.34 to 5.92 1.50 post), Vigor-Activity, a positive score where higher numbers are better (pretest active CES mean of 14.76 1.21 to 15.08 1.02 post, control pretest 14.76 1.25 to 13.00 1.40 post), Fatigue-Inertia-Confusion (pretest active CES mean of 6.18 1.12 to 1.91 0.53 post, control pretest 6.45 1.29 to 4.05 1.32 post), and Confusion-Bewilderment (pretest active CES mean of 8.08 0.99 to 3.92 0.49 post, control pretest 8.00 0.96 to 6.08 0.67 post). The CES group also improved significantly on Total Mood Disturbance while the controls did not (pretest active CES mean of 65.29 6.62 to 40.33 4.69 post, control pretest 63.96 6.56 to 47.29 6.12 post). The groups had to be matched following the study prior to statistical analysis, since a majority of the most seriously stressed controls (N = 13) had left the hospital against medical advice, along with 12 CES pts. No side effects were reported.
63. Smith, Ray B., Tiberi, Arleine, Marshall, John. The use of cranial electrotherapy stimulation in the treatment of closed-head-injured patients. Brain Injury, 8(4):357-361, 1994.
Device: CES Labs, 100 Hz, 20% duty cycle, <1.5 mA
21 closed head injured pts with an average age of 30, and time since injury ranging from 6 months to 32 years (mean = 11) completed informed consent. The statistician was also blinded, being given the data in 3 unidentified groups, making this a triple-blind study. They were randomly assigned to CES treatment (N = 10), sham treatment (N = 5) or control "wait-in-line" (N = 6) groups. The CES and sham groups had 12 treatments, daily over a period of 3 weeks. They were pre- and post-tested on the Profile of Mood States which contains subscales for anxiety, depression, hostility, fatigue and mental confusion. The CES treated subjects, but not the sham treated subjects or controls, improved significantly on every POMS subscale. Tension/anxiety was reduced from a mean of 12.33 7.36 to 8.78 5.09 in the CES treated group, while it rose from 13.00 6.21 pretest to 14.36 8.25 post test in the sham group, and barely changed from 12.33 8.07 to 12.50 5.87 in the control group. Depression/dejection changed from 17.11 12.35 to 12.06 8.71 in the CES treated group, and from 20.91 17.79 pretest to 18.18 12.47 post test in the sham group, and from 20.00 14.45 to 16.17 9.48 in the control group. Anger/hostility changed from 13.67 11.20 to 10.39 7.49 in the CES treated group, and from 16.73 8.27 pretest to 17.55 12.22 post test in the sham group, and from 14.83 11.50 to 14.83 6.18 in the control group. Fatigue/inertia changed from 7.44 6.75 to 5.33 3.96 in the CES treated group, and from 9.46 7.83 pretest to 8.09 6.63 post test in the sham group, and from 8.17 7.41 to 6.50 5.82 in the control group. Confusion/bewilderment changed from 8.50 6.75 to 6.22 3.96 in the CES treated group, and from 10.55 5.87 pretest to 10.27 5.10 post test in the sham group, and from 9.67 6.15 to 10.50 5.01 in the control group. Total Mood Disturbance was reduced from a mean of 45.11 41.95 to 31.89 23.84 in the CES treated group, and from 52.73 41.95 pretest to 52.33 36.64 post test in the sham group, and from 47.83 43.25 to 45.67 24.16 in the control group. 1 pt on sham CES was seen to have a seizure. No negative effects from CES treatments was seen. The authors concluded that therapists of CHI pts may well try adding CES therapy, a prescription, but non-medication treatment, to the treatment of this currently heavily medicated pt population.
76. Wharton, G.W. et al. The use of cranial electrotherapy stimulation in spinal cord injury patients. A poster study presented at the American Spinal Injury Association Meeting, New York, 1982, and at the Texas ASIA meeting in Houston, 1983.
16 inpatients on the Spinal Cord Injury Ward were measured on the POMS, the STAI, and the IPAT Depression Scale. Five were paraplegic and 11 were quadriplegic. They averaged 3.7 months post trauma. 11 were given CES, 40 minutes per day for 10 days. 5 served as hospital routine controls. The CES treated pts improved significantly on the Tension/Anxiety, Depression/Dejection, Fatigue/Inertia, and Confusion/Bewilderment factors on the POMS, on both the state and trait factors on the STAI, and on the IPAT Depression Scale. The control group did not improve on any of the measures. Abstract courtesy of Ray B. Smith, Ph.D., M.P.A.
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