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Sleep / Insomnia

9. Empson, J.A.C. Does electrosleep induce natural sleep? Electroencephalography and Clinical Neurophysiology. 35(6):663664, 1973.

Device: Somlec 3, 20 Hz, 250 µS, DC pulses

This study was completed in the era when CES was called "electrosleep" and the thought was that it had no effect other than putting patients to sleep. In this study 8 student volunteers spent an acclimation night and two experimental nights in a sleep laboratory with CES and EEG monitoring. 1 went to sleep, the other 7 were made more alert on the EEG, but described it as an interesting, restful experience. CES was only given for 5 minutes although the author states that it is recommended that treatments last 1.5 - 2 hours. The authors concluded that while it did not make these (noninsomniac) subjects sleep, "It is possible that electrosleep may alter the mood of tense, anxious people so that they are more likely to get to sleep when they go to bed." 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.

12. Flemenbaum, A. Cerebral Electrotherapy (Electrosleep): An open clinical study with a six month follow-up. Psychosomatics. 15:2024, 1974.

Device: Electrosone 50: 100 Hz, 1 mS, cathodes over orbits, anodes over mastoids

28 anxiety, depression, and insomnia outpatients who had been symptomatic for at least 3 - 4 years and unresponsive to extensive previous treatments were divided into 3 groups and given 5, 30 minute CES treatments. 3 pts left the study, 1 due to complaints of worsening of her nervousness after 3 treatments, 1 left after 4 treatments and could not be located, another died of an overdose 3 months after the treatments, but before the researchers could determine why he left the study. Group I pts (N=14) had no other serious complicating psychiatric disorders, Group II (N = 7) was comprised of pts whose target symptoms were secondary to physical, somatic difficulties, and group III (N = 4) had a history of psychotic episodes. All pts were on psychotropic drugs. Only historical controls were employed in this study. The Zung depression scale and clinical global impressions (1 - 7 scale) were employed pretreatment, and for follow-up at weeks 6, 16, and 24. By the 6th week the pathology for the 3 groups seemed to be reduced to approximately equal levels. An insignificant trend towards worsening was seen by the 24th week. Comparison of the final results with the pretreatment ratings shows improvement statistically significant at the .01 level. The author noted that at the end of the study 12 of the 25 pts were much, or very much improved, 8 had shown some effect, though minimal, and 5 were not improved or had become worse. Some of these chronic pts were practically asymptomatic, other psychophysiological symptoms like asthma and blood pressure had become controllable by regular medical treatment, and/or their target symptoms showed complete or nearly complete remission. Most remarkable of all, these changes occurred in pts who previously had not responded to extensive treatment. Although about 50% of the pts showed minimal improvement, or none at all, those who had beneficial results maintained them throughout the 6 month follow-up. The author added that side effects are virtually nonexistent. It was concluded that this treatment seems to be an excellent modality for pts. Its safety and economy recommend its freer trial.

13. Forster, Sigmund, Post, Bernard, S., and Benton, Joseph G. Preliminary observations on electrosleep. Archives of Physical and Medical Rehabilitation. 44:8189, 1963.

Device: A device was fabricated, 20 Hz, 0.2 - 0.3 mS, 0.5 - 5 mA, rectangular pulses

This study was designed to test the effects of CES for inducing sleep, and as usual, had variable results. They did find that whether or not patients went to sleep, "there is a clinically noticeable effect of electrosleep upon muscle spasticity in patients with hemiplegia and paraplegia and upon muscle spasm in traumatic injuries such as low back syndromes." These results were confirmed with EMG readings in their 6 normal and 17 clinical pts. There were no controls so the effects of lying supine during an average of 3.56 sessions were not screened out. Although as current amplitude was increased to 20 volts a feeling of slight dizziness approaching a headache was noted, the authors concluded that the technic appears to be entirely safe. Follow-up of pts up to 1 year after treatment has not revealed any harmful effects. The authors suggested that CES may be a potentially valuable technic in the management of certain pts undergoing rehabilitation.

14. Frankel, Bernard L., Buchbinder, Rona, and Snyder, Frederick. Ineffectiveness of electrosleep in chronic primary insomnia. Archives of General Psychiatry. 29:563568, 1973.

Device: Electrosone 50: 100 or 15 Hz, 1 mS, 100 - 700 µA, square waves, cathodes over orbits, anodes over mastoids

17 insomniacs referred from local physicians with an average duration of symptoms for almost 20 years were given 15, 45 minute CES treatments Monday through Friday at 100 or 15 Hz, a week off, then 15 more treatments at 15 or 100 Hz in a crossover design with each group split in half. Both the 100 Hz and 15 Hz groups appeared to be combined for the 3rd week and 7th week measurements. There were no changes in the EEG, sleep onset time, sleep efficiency, total number and duration of awakenings, etc. The Taylor Manifest Anxiety Scale did not change (Pretreatment means of 21.0 9.3, after 15 treatments 19.9 10.1, after 30 treatments 19.2 10.1, at 1 month follow-up 20.5 9.6) nor did the Zung depression scale. 17hydroxycorticosteroid levels did not change. All of these changes have been found in other controlled studies, so Frankel's findings stand virtually alone in the literature. Note: From the write up, it is not clear that the authors did not combine the two groups for the final statistical analysis, even though Frankel noted in his introduction the comment made by Obrosov in the European literature that hertz of different levels should not be mixed when treating the same patient, as was done in this study, since beneficial effects can be eliminated or canceled out. We also now know that beneficial gains from CES treatment tend to increase following the initial treatment. Such effect, when present, would nullify the expected effect in crossover designs involving sham (or other) treatment. A commonly reported innocuous side effect was mild blurring of vision lasting 15 to 30 minutes which resulted from the sustained mechanical pressure of the electrodes on the eyeballs.

17. Gomez, Evaristo and Mikhail, Adib R. Treatment of methadone withdrawal with cerebral electrotherapy (electrosleep). British Journal of Psychiatry (London). 134:111113, 1979. Also in Gomez, Evaristo and Mikhail, Adib R. Treatment of methadone withdrawal with cerebral electrotherapy (electrosleep). Paper presented at the annual meeting of the American Psychiatric Association, Detroit, 1974.

Device: 100 Hz, 2 mS, 0.4 - 1.3 mA, electrodes from the forehead to mastoids

For this single blind study, 28 male heroin addicts, between 18 and 60 years old, undergoing methadone detoxification were selected on the basis of having severe anxiety as measured by the Hamilton Anxiety Scale and Taylor Manifest Anxiety Scale, difficulties in sleeping, willingness to participate in the study for at least 2 weeks in a locked ward, and agreement not to take any tranquilizers or hypnotics while in the study. This was a self medicated withdrawal study in which methadone was given as requested by the patients as needed to control their withdrawal symptoms. The pts were then randomly divided into a CES treatment group (N = 14) who were taking 20 - 60 mg of methadone/day, a placebo group (N = 7) taking 30 to 40 mg/day, and a waiting in line control group (N = 7) taking 25 - 40 mg/day. CES or sham CES was given for 10 days, Monday through Friday, 30 minutes per day. After 6 - 8 CES treatments, methadone intake was 0 in 9 pts, with another 1 at 0 after 10 treatments. 3 were taking 10 - 15 mg after the 10 treatments. The other active pt dropped out of the study after the first treatment. The pts reported feeling restful and having a general feeling of well-being, their sleep was good and undisturbed after 3 treatments. The Taylor Manifest Anxiety Scale scores also came down significantly in the CES group with 7 pts dropping from a mean of 31 before CES to 20 after 10 days (normal is 8 - 18), while the others showed a 25 - 50% reduction. Sham CES pts showed an insignificant change in the mean TMAS scores from 29 to 27. The methadone intake did not change in 4 sham CES pts, and only dropped 5 - 10 mg in the other 3. These pts were anxious and depressed, and complained of difficulty sleeping and somatic problems. The 7 controls also did not do well, TMAS scores increased in 2 cases, was the same in 1, and only decreased 1 - 2 points after 10 days in the remainder. The methadone intake was the same in 3 controls, and decreased in the other 4 after 10 days. These pts were anxious, had difficulty sleeping. HAS scores were also diminished in the CES group but not the placebo or controls. It was noted that with a higher current, the pt felt uncomfortable, but there were no skin burns.

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.

23. Itil, T., Gannon P., Akpinar, S., Hsu, W. Quantitative EEG analysis of electrosleep using frequency analyzer and digital computer methods. Electroencephalography and Clinical Neurophysiology. 31:294, 1971.

Device: Electrosone 50

10 male volunteers received EEG recordings with two days of CES and two days of sham CES in a crossover design. Pts who exhibited no decrease of vigilance when CES was off also showed no significant changes when CES was on. Those showing a slighttomoderate drowsiness during the off recording did show a slighttomoderate sleep pattern when the CES was on. There was no significant EEG difference between the on and off sessions recorded during resting time. However, during reaction time measurements there was an increase in 510 c/sec activity and a decrease in fast alpha and beta activity when CES was on as compared with the recordings taken with CES off. No side effects were reported.

29. McKenzie, Richard E., Rosenthal, Saul H., and Driessner, Jerry S. Some psychophysiologic effects of electrical transcranial stimulation (electrosleep). American Psychiatric Association, Scientific Proceedings Summary. 1971. Also in The Nervous System and Electric Currents, Wulfsohn, N.L., and Sances, A. (Eds.) Plenum: New York, Pp. 163167, 1976.

Device: Electrosone 50: 100 Hz, 1mS, 0.1 - 1.9 mA, cathodes over orbits, anodes over mastoids

8 psychiatric pts with a clinical history of chronic anxiety with depression and insomnia, and 4 normal staff "controls" were given 1, 30 minute CES treatment a day for 5 days. Psychophysiological measurements were made on day 1 and day 5. All pts had slower EEG frequencies with increased amplitude in the frontotemporal areas following CES. 7 pts showed increased quality and quantity of alpha with increased amplitude in the occipitalparietal leads. The submental EMG showed increased relaxation but was too variable to be a reliable measure. The skin potential recordings (SPR) revealed a definite overall state of relaxation as the treatments progressed from an average of 24.55 millivolts to an average level of 12.75. Normal controls were comparable with the pts exhibiting a drop in SPR's of 25.29 to 5.76. The subjective reports of the normal subjects were unexpected. Only a mild sedative effect was expected. However, 3 of the 4 normals reported an activation or alerting effect. 1 of these reported hyperalertness with hyperirritability. A second experienced a helpful increase in energy and another a feeling of alertness. 2 controls experienced feelings of euphoria with periods of silliness or giddiness, along with this they felt a lack of worry about real situational problems. In fact, they were worried over not being able to worry. All of these effects dissipated rather rapidly in 24 - 48 hours. The authors noted that blurring of vision due to eye electrode pressure was fairly uniform over the small control sample and was not especially uncomfortable.

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.

32. Magora, Florella, Beller, A., Aladjemoff, L., Magora, A., and Tannenbaum, J. Observations on electrically induced sleep in man. British Journal of Anesthesiology. 37:480491, 1965.

Device: 100 Hz, 10 - 100 Hz, 1 - 10 mS, 0.4 - 5 mA, square pulses, cathodes over orbits or forehead, anodes over mastoids

The authors were studying CES to determine what it took to put a patient to sleep. They varied hertz, amplitude, pulse width and the like, performing 65 experiments. The subjects were healthy volunteers, 5 females and 10 males with ages ranging from 30 - 45 years, 2 pts with Parkinson's disease (a 62 year old female and a 82 year old male), and 1 male, 65, with dystonia musculorum. All subjects were advised to refrain from taking any drugs 12 hours prior to the experiments. In a group of 7 healthy subjects, the 2 pts with Parkinson's, and the 1 with dystonia musculorum, sleep did occur in most of the experiments as measured by objective criteria (respiration, EEG, EMG). An unexpected finding was that the involuntary movements in the pts with Parkinson's and dystonia musculorum were changed in character during the passage of current, and eventually completely eliminated, as evidenced by clinical and EMG observations. Sleep was not induced in a second group of 13 healthy individuals, although in 7 a definite change was obvious consisting of lack of blinking, preference for eyes closed, passiveness, and disruption of the idea pattern obvious in conversation. On questioning, after the current was discontinued, these subjects had no evaluation of the lapsed time and stressed that while the current was on they felt detached from their surroundings and had an agreeable feeling throughout the experiment. No ill effects were observed after repeated experiments in the same and different individuals.

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.

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.

49. Ryan, Joseph J., and Souheaver, Gary T. The role of sleep in electrosleep therapy for anxiety. Diseases of the Nervous System. 38(7):515517, 1977.

Device: Neurotone 101, 100 Hz, 2 mS, electrodes on forehead and mastoids

40 neurotic inpatients at a Veterans Administration hospital exhibiting significant symptoms of anxiety without psychosis or neurological impairment either not on medication or not responding satisfactorily to psychotropic medication who gave informed consent were given the A-State Scale of the STAI which measures various emotional reactions such as tension, worry, apprehension, and nervousness. Each pt underwent 5, 30 minute CES treatment sessions, with a therapist in the room to record clinical observations of sleep indicators (e.g., snoring, shallow breathing, difficulty in arousal after treatment). 6 - 9 days after treatment the pts completed the A-State Scale again. 10 males (21 - 59 years old, mean = 34.10) were selected for which there existed a definite agreement between patient and therapist that sleep had occurred during 2 or more treatment sessions. Similarly, 10 nosleep patients (9 males, 1 female, 26 - 57 year old, mean = 41.9) were also selected. Both groups improved significantly (P<.001) on the State Anxiety Scale of the STAI, with no significant differences in improvement in the sleep group when compared with the nosleep group based on a 2 x 2 ANOVA with repeated measures on pre- and post treatment scores. The sleep group went from a pretreatment mean anxiety score of 59.20 12.72 to 49.00 18.52 post treatment. The no-sleep group means fell from 59.80 9.89 to 41.90 15.07. It was concluded that sleep is not necessary for the effects of CES to occur. No side effects were reported.

55. Singh, Baldev, Chhina, G.S., Anand, B.K., Bopari, M.S.,and Neki, J.S. Sleep and consciousness mechanism with special reference to electrosleep. Armed Forces Medical Journal (New Delhi). 27(3):292297, 1971.

4 normal subjects showed increased alpha index immediately following CES (up to 45 minutes), which culminated in spindle and slow sleep after a variable interval. In 6 pts suffering from subjective insomnia the passage of current resulted in increased alpha activity and a subjective feeling of well being but was not accompanied by either slow or paradoxical sleep. Abstract courtesy of Ray B. Smith, Ph.D., M.P.A.

68. Stanley, Theodore, H., Cazalaa, Jean A, Limoge, Aime, and Louville, Yves. Transcutaneous cranial electrical stimulation increases the potency of nitrous oxide in humans. Anesthesiology. 57:293-297, 1982.

Device: 167 Khz, 250 - 300 mA (average intensity was 0 mA?), 3 mS

IRB approved. 90 urological pts and 30 abdominal surgery pts (total N = 120, with a mean age of 47 13 years) were randomly assigned to 1 of 3 active CES groups (1E, 2E, 3E), or 1 of 3 control groups (1, 2, or 3), with N = 30 per group. Groups 1 and 1E received 75% N2O, groups 2 and 2E received 62.5% N2O, groups 3 and 3E received 50% N2O. After 20 minutes of N2O or N2O and CES, pts were given a painful stimuli of a Kocker clamp clamped to the second ratchet applied to their upper, inner thigh for 1 minute. An observer blind to the CES condition and the amount of N2O recorded pt movement due to the painful stimulus. Additional recordings made by the blinded observer were systolic BP (SBP), heart rate (HR), respiratory rate (f), and minute ventilation (V) measured before N2O or N2O plus CES, after 20 minutes, and following the 1 minute of painful stimulation. 20 minutes after all procedures, the pts were asked if they remembered any painful stimulus. Data was evaluated by chi-square test, analysis of variance, and Student's paired and unpaired t-tests. P<.05 was considered statistically significant. Breathing N2O resulted in a significant, but similar small increase in SBP in all groups but no change in HR in any group. Breathing N2O slightly increased f and V in groups 1 and 1E but produced no significant changes in f and V in any of the other groups. HR, SBP, f, and V were not significantly different in the 6 groups after 20 minutes of breathing N2O. Painful stimulation did not significantly change HR, f, or V when compared to values obtained 1 minute prior to the stimulus in any group. SBP also was unchanged with painful stimulation in all groups except in control group 3 in which it became significantly increased. During painful stimulation, SBP was significantly higher in control group 3 than in all other groups. Movement with and memory of the Kocker clamp application, as well as the postanesthetic pain in the area of clamp application were significantly lower in the CES groups at all N2O concentrations. As might be expected, positive responses increased in all groups as the N2O concentrations decreased. A plot of percent of pts moving with painful stimulation during N2O and N2O plus CES versus concentration of N2O indicates that CES increases the potency of N2O approximately 37% (at least to this form of painful stimulation. The authors also concluded that CES prolongs the analgesia after recovery of consciousness, and that the data suggests that CES appears to be equivalent to 35 - 40% N2O or between 0.3 and 0.4 MAC in analgesic potency when combined with N2O. Theoretically, it should be possible to use lower concentrations of inhalation anesthetics and lower doses of narcotics and other intravenous supplements when using CES. As a result, major organ system alterations in function should be less during anesthesia and postoperative recovery should be faster. In addition, the use of CES during operations may provide residual postoperative analgesia without chemical analgesic administration. These possible advantages of CES, if proven true in subsequent studies, could certainly alter both the research and clinical directions of anesthesiology. No side effects were reported.

70. Taaks, H., and Kugler, J. Electrosleep and brain function. Electroencephalograpy and Clinical Neurophysiology. 24:6294, 1968.

Device: 100 Hz, 600 µA, cathodes on orbits and anodes on neck

In this early study attempting to put people to sleep, 7 female depressives (17 - 65 years old) were given CES for 20 minutes or a sham CES (actually 5 minutes of CES) for 20 minutes, 3 or 4 times on 7 successive days and measured for sleep or wakefulness with EEG, EOG, respiratory abdominal movements and body movements recorded for 20 minutes. The stages of sleep according to Loomis were determined visually for 40 second periods. Some slept under either or neither condition, some did not. No side effects were reported.

75. Weiss, Marc F. The treatment of insomnia through use of electrosleep: an EEG study. Journal of Nervous and Mental Disease. 157(2):108120, 1973.

Device: Electrodorn I, electrodes on forehead and neck

10 pts with objectively established insomnia were randomly selected from 40 volunteers solicited by newspaper ads. The subjects spent 3 initial nights in a sleep lab to establish baseline measurements, and then returned for 2 nights at the end of the study and again for follow-up. They were given 24, 15 minute CES treatments (N = 5) or simulated treatments (N = 5) in a double-blind manner and measured before and after treatment, and after a 14 day post treatment period. The MMPI was used to establish equivalency of groups. EEG latencies of sleep onset in minutes for the CES group pretreatment means was 60.8 to 10.6 post treatment, and for the sham group 60.5 to 58.8. The CES group had a significant decline in latency of sleep onset (P=.00077), percentage of bed time awake (CES pretreatment 19.334 to 4.192 post, and sham 17.296 pre to 18.500 post, P=.367), and percentage of total sleep time in stage 1 sleep. A significant increase in the total sleep time in stage 4 and total delta sleep was also found in the CES group. All differences found were maintained at the 2 week and 2 year follow up. No significant improvement was found in the placebo group. The author stated that we can now conclude that CES is effective in the treatment of chronic, sleep onset insomnia. No side effects were reported.

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