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Physical Disorders

Bronchial Asthma

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.

Cerebral Palsy

28. Logan, Michael P. Improved mechanical efficiency in cerebral palsy patients treated with cranial electrotherapy stimulator (CES). Unpublished, 1988.

Device: Pain Suppressor, 15,000 Hz, 50mS, 500 - 700 µA, electrodes placed above ears

36 spastic type cerebral palsy pts completed informed consent and were divided into 18 CES and 12 placebo CES in this double-blind study. Both groups performed a graded exercise test on a Tunturi bicycle ergonometer. Pedaling speed was recorded in revolutions per minute (RPM), and the resistance to pedaling in Newton's (N). The workload was started at 0 and increased by 2 N every 2 minutes based on heart rate (HR), blood pressure (BP), and ability to maintain pedal velocity. HR was measured every minute by an EKG. Expired gases were measured every minute, and BP every 2 minutes. 6 pts were dropped from the study because 3 were not able to maintain pedaling motion, while another 3 voluntarily withdrew. The absolute test value differences were subjected to a 2 factor analysis of covariance. The mean poststimulation mechanical efficiency (ME) in the CES group increased by 19.1% (from 50.3 to 59.9), while the placebo group dropped by 9.1% (53.3 to 48.4). Workloads of treated pts improved by an average of 43% (mean of 65.9 to 94.3). This is a remarkable increase, especially when one considers that the placebo retest scores declined by 5.5% (mean of 75 to 70.9). The F statistics for the unit factors in ME was significant at the .0003 level. The authors concluded that the results indicate that CES does, in fact, improve the work performance of cerebral palsy pts and that the most likely explanation is that spacticity was reduced in the actively treated pts. There was no report of side effects. Dr. Logan received the Richmond Award from the American Academy for Cerebral Palsy and Developmental Medicine for this work.

33. Malden, Joan W., Charash, Leon I. Transcranial stimulation for the inhibition of primitive reflexes in children with cerebral palsy. Neurology Report. 9(2):33-38, 1985.

Device: Neurotransmitter Modulator

In this double-blind crossover study 20 children (2.5 months to 15 years old) with normal intelligence and mild to severe spastic cerebral palsy completed informed consent and were then divided into real and placebo CES groups, each having 6 weeks of 2, 10 minute daily treatments and then the groups were reversed. The results were evaluated using the Malden Gross Motor Rating Scales I, II, and III, and the Advanced Gross Motor Skills Scale, which together constitute a total gross motor picture. Group A (active/placebo) had an original assessment of 37.2 measured an average of 13.1 months prior to the study, 52.9 at the start of the study, 79.4 at crossover, and 81 at the end of the study. The mean improvement of 26.5 points for Group A with active treatments was significant compared to the mean value of 1.6 points during the placebo period. Group B (placebo/active) had an original assessment of 36.83 measured an average of 37.16 months prior to the study, 85.4 at the start of the study, 87.9 at crossover, and 102 at the end of the study. The mean of Group B during the placebo period of 2.5 points was not significant compared to the 14.1 gain during the active period. The authors concluded that the results of this study are highly significant and would seem to indicate that the treatment of children with spastic cerebral palsy with CES in addition to physical therapy is superior to conventional treatment offered alone. Placebo treatments have little further effect on conventional treatment. No side effects were reported.

38. Okoye, Renee, Malden, Joan W. Use of neurotransmitter modulation to facilitate sensory integration. Neurology Report. 10(4):67-72, 1986.

Device: Neurotransmitter Modulator

16 pts, from 5 - 25 year old, with neurological diagnoses ranging from minimal cerebral dysfunction to cerebral palsy and spastic quadriplegia having at least borderline intelligence were divided into 3 groups for this 12 week non-blinded study. The CES groups were treated twice daily. Assesments were made using the Southern California Sensory Integration Test, and the Jebsen hand function test. The design copying scores for pts who received CES, without occupational therapy (OT) averaged 59%. Pts receiving OT without CES averaged 35%, and pts receiving both CES and OT averaged 88%. Motor accuracy showed a tremendous improvement in the 2 CES groups over the OT-only group, with the CES only group changing 43% in their dominant hand, and 21% in their non-dominant hand, the OT only group averaging 15% in their dominant hand, and 45% in their non-dominant hand, and the combined therapy group averaging 53% change in their dominant hand, and 68% in their non-dominant hand. In conclusion, the authors stated that CES pts whose scores showed moderate impairment during pretest trials improved to within normal limits in a 12 week period, and that these findings were remarkable. No side effects were reported.

Closed Head Injury

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.

77. Wilson, L.F. and Childs, A. Cranial electrotherapy stimulation for attentiontotask deficit: A case study. American Journal of Electromedicine. 5(6):9399, 1988.

Device: RelaxPak, 100 Hz, 2 mS, 1 mA, sine wave, bilateral electrodes

4 pts with measurable attentiontotask deficit were studied. 2 had severe pain problems (27 year old female and 30 year old male) but no brain injury, while 2 had suffered from post brain trauma (29 year old male, 25 year old female). One of the pain pts served as placebo control (the 30 year old male) for the other 3, each of whom served as his or her own control. CES was given for 50 minutes per day, 5 days a week for 3 weeks. Pts were pre- and post-tested on standardized cognitive measures (Trail Making Test, Digit Symbol Test, Porteus Mazes, Consonant Trigrams Test, Rey Auditory-Verbal Learning Test, Paced Serial Arithmetic Test) before and following CES, and again 3 weeks later. Pts were also tested on the Profile of Mood States Inventory. The results among the CES treated pts showed striking and significant improvement in the post treatment scores and in the associated extent of the neurological deficit. It was concluded that CES is an effective nondrug alternative in a cognitive rehabilitation model for treating attentiontotask deficit. No side effects were reported.

Dental Anethesia

6. Clark, Morris S., Silverstone, Lwon, M., Lindenmuth, James et al. An evaluation of the clinical analgesia/anesthesia efficacy on acute pain using the high frequency neural modulator in various dental settings. Oral Surgery, Oral Medicine, Oral Pathology. 63(4):501-505, 1987

Device: high frequency neural modulator, 15 Hz, 4 mA, temporal electrodes, and introral to

hand electrodes

50 healthy, nonpregnant dental pts from 16 to 60 years old were separated into an experimental group (N=30), and placebo group (N=20) in this double-blind study to evaluate the effectiveness of CES and peripheral stimulation as a substitute for local anesthesia in various dental procedures, including oral surgery, restorations, tooth extractions, root planing, pulp extirpation, and temporomandibular joint therapy. The degree of pt comfort and satisfaction, their request for local anesthetics, as well as manageability of pain control by the dentist was evaluated. In the experimental group, favorable responses ranged from 0.0% to 92.8%, depending on the procedures. 24 of 30 (80%) CES pts were able to undergo dental procedures without anesthesia. 15 of 20 (75%) of the placebo group required anesthesia. In the operative group, 13 of 14 pts were treated successfully with CES, whereas only 3 of 7 placebo CES pts did well, which is significant at the 0.05 level. All 3 of the CES pts and all 3 placebo CES pts required anesthesia for endodontic procedures. An overall favorable rating of 71.8% was given by the experimental group, whereas an overall favorable response of 8.5% was given by the placebo group. Pts gave favorable comments and all stated that this procedure would be their first choice in future visits. No side effects were reported.

22. Hochman, Richard. Neurotransmitter modulation (TENS) for control of dental operative pain. Journal of the American Dental Association. 116:208-212, 1988.

Device: Neurotransmitter Modulator, electrodes across temples

This is an unblind study of 600 dental procedures over a 1 year period. Although the author refers to the device as a TENS, electrodes were placed across the temples for 10 minutes prior to each procedure which makes the treatment CES by definition. The procedures ranged from vigorous subgingival scaling to endodontic. Results were evaluated for pain control related to procedure type, and the patients' skepticism about the procedure. Results were considered positive if the patient reported greater than 90% reduction in pain and did not request the additional administration of local anesthetic. More than 76% of the pts in all procedures reported 90% or greater success using CES for dental analgesia. For the 71 scaling and prophylactic procedures, more than 83% reported successful pain reduction, and for the 473 restorative procedures, more than 76% reported pain reduction success. For 29 crown preparations, "only" 55% reported success. The majority of pts were skeptical about the procedure but after experiencing CES they were more comfortable with CES than they were with previous dental experiences. The author concluded that from the results obtained during 1 year of treating a variety of pts requiring a broad scope of dental treatments, CES was found to provide a safe, noninvasive, readily acceptable, adjunctive analgesic modality to maintain pt comfort through the majority of dental procedures for most pts. Additional, unexpected positive results were found when the pts reported "feeling more relaxed than usual." No side effects were reported.

Fibromyalgia

43. Romano, Thomas. The usefulness of cranial electrotherapy in the management of headache in fibromyalgia patients. American Journal of Pain Management. 3(1):15-19, 1993.

Device: Pain Supressor, 12,000 to 20,000 Hz, 35µS, <4 mA, electrodes across temples

100 consecutive fibromyalgia syndrome (FS) pts (23 males ages 22 - 58, mean = 45, and 77 females ages 18 - 65, mean = 46) in a rheumatology practice with severe chronic headache unresponsive to outpatient treatments of medications (NSAIDS, beta blockers, tricyclics, and ergots), biofeedback, low tyramine diet, local injections, and physical therapy were given CES units and instructed to use them for 20 minutes, 4 times daily while continuing their medications. 75 completed the study. Dolimetry using a pressure algometer was performed at 6 active typical "tender" sites just before CES and 1 - 2 months after. Pts were also asked to rate their headache severity on a 1 - 10 scale (1 = no effect, 10 = totally effective in relieving headaches) before CES, at a subsequent visit, and at follow-up. CES proved to be effective in FS-related headache pts. Approximately 50% of FS Pts using CES regularly reported a significant decrease in the frequency and intensity of their headaches. The mean pretreatment headache intensity score was 8.1 (7.8 for males, 8.4 for females). After 1 - 2 months of CES treatment, the mean score was 4.7 (4.5 for males, 4.8 for females). The difference in the mean scores was 3.4 (3.3 for males, 3.6 for females) and there was definite subjective improvement. Dolimetric testing of 450 sites ( 6 per pt) revealed that 42% (189) were improved (had values increased > 1 kg/1.54 cm), 19% (86) were worse, and 39% (175) were unchanged. 8 pts reported absolutely no benefit, 6 stated they were entirely free of headaches, while 15 (20%) reported CES efficacy as a "7", indicating moderate improvement in both frequency and severity of headaches. 38 (51%) rated improvement as a "7" or greater. The author concluded that CES is a helpful adjunct in the treatment of FS pts with headache previously unresponsive to more conventional techniques. No side effects were reported.

Gastric Acidity

25. Kotter, Gary S., Henschel, Ernest O., Hogan, Walter J., and Kalbfleisch, John H. Inhibition of gastric acid secretion in man by the transcranial application of low intensity pulsed current. Gastroenterology. 69:359363, 1975.

Device: Electrodorn I: 100 Hz, 1 mS, 0.1 - 1.5 mA, rectangular wave, cathodes frontal, anodes occipital

Following up on an earlier positive study in primates, 5 hospitalized adult male volunteers from 28 to 58 years old completed informed consent and had their basal acid secretion rate in their stomachs measured by intragastric titration utilizing a pHsensitive telemetry capsule that was swallowed while held on a tether outside the subject's body. On a randomized basis, no current was passed through the electrodes during one of the tests, whereas a mean of 1 mA was applied during the other. Acid secretion was halted during or after CES. In a second study, 12 subjects had histaminestimulated acid output reduced by an average of 30% with CES, with individual reductions ranging from 5.7% to 53.2%. There was no acid reduction during simulated CES treatments. A third study showed histamine-stimulated maximal acid output (MAO) decreased by 6.3 - 46.5%, with an average of 27.3% below control values in 6 volunteers. Acid secretion gradually began again when CES was terminated. The results of all 3 studies (N = 23) indicate that CES can cause a highly significant reduction in both basal and histamine stimulated gastric acid output. No side effects were reported.

Headache

4. Brotman, Philip. Low-intensity transcranial electrostimulation improves the efficacy of thermal biofeedback and quieting reflex training in the treatment of classical migraine headache. American Journal of Electromedicine. 6(5):120-123, 1989. Also doctoral dissertation, City University Los Angeles, 1986.

Device: Alpha-Stim 2000GL, 0.5 Hz, 50% duty cycle, <500 µA, biphasic rectangular waves, ear clip electrodes

In this double blind study, 36 females, ages 18-40, suffering from classical migraine headaches (ICD-9 346.0), completed informed consent and were randomly assigned to Quieting Reflex Training (QR) and placebo CES (N = 12), QR plus actual Alpha-Stim CES (N = 12), or CES only groups (N = 12). All groups were measured for temperature changes using thermal biofeedback (TB) via finger monitors on the dominant hand, and temporalis muscle EMG. All received 8 treatments (length unspecified), plus 1, 2, and 3 month follow up sessions. Medication levels dropped dramatically from the initial session to the eighth session. T-tests were employed seperately for investigation of CES and QR. Results were calculated using the formula of frequency x intensity of headaches. The findings were that groups receiving TB and QR, either with CES (pretreatment mean of 14.42 6.26, post treatment of 4.50 5.30) or with placebo CES (pretreatment mean of 15.33 6.62, post treatment of 4.33 4.46), responded significantly better than did the TB CES group alone (pretreatment mean of 14.00 4.56, post treatment of 6.33 4.38), but that the group receiving TB, QR, and CES responded significantly better (mean of .08 0.28) than the TB, QR and placebo CES group (mean of .58 1.19) or the TB and CES group (mean of 8.67 6.60) at the 3 month follow up period. Only the CES group showed significant carry over effects in finger temperature. EMG findings of the CES groups showed a recovery to normal 15 minutes after treatment. Those groups that did not receive the CES treatment were subsequently treated with CES and they achieved headache reductions comparable to those obtained in the TB, QR, and CES group. Observations during the study suggested that CES may contribute to both a rapid rise of finger temperature during each session and to a homeostatic rise in finger temperature over time. It was suggested that this was possibly due to a hypothalamic mechanism. No subjects in CES or placebo CES groups reported side effects.

10. England, Ronald R. Treatment of migraine headache utilizing cerebral electrostimulation. Masters Thesis, North Texas State University, Denton, Texas, December, 1976.

Device: Neurotone 101, 100 Hz, 2 mS., electrodes behind each ear

18 migraine pts, 6 males and 12 females ranging from 21 to 62 years old (mean of 37.9) were solicited by newspaper ads. After giving informed consent, The 3 groups of 6 pts each were matched on the basis of headache intensity during a 2 week baseline period and divided into CES treatment, simulated treatment, and waiting list control groups. CES was given 45 minutes per day for 15 days, Monday through Friday. A Wilcoxon matched-pairs, signed-ranks test was calculated for the difference scores for each of the variables of headache frequency, intensity, and duration. The frequency of headaches had not changed significantly by the end of the study. There was no significant difference in intensity of headaches after the second week of treatment, however, when both baseline periods were compared to the results of the third week of treatment, the CES group was found to have significantly (P< .025) lower headache intensity ratings than the placebo group. There was a significant (P<.05) reduction in duration of headache among CES pts over placebo after the second week. The waiting list control group reported improvement also, but they were asked to recall their week's experience over the telephone on Friday only, while the treatment and placebo groups were asked to keep a written record on a daily basis. It was noted that the recordings may not have been comparable and that the variable of medication usage tended to confound the results. The frequency, intensity, and duration of pain did not change in the placebo pts during or following the study. The author concluded that CES does consistently better than placebo control. 1 subject in the placebo group developed a skin irritation at the location of the electrode. She suggested that sensations felt during the treatment were responsible. No side effects from CES were reported.

43. Romano, Thomas. The usefulness of cranial electrotherapy in the management of headache in fibromyalgia patients. American Journal of Pain Management. 3(1):15-19, 1993.

Device: Pain Supressor, 12,000 to 20,000 Hz, 35µS, <4 mA, electrodes across temples

100 consecutive fibromyalgia syndrome (FS) pts (23 males ages 22 - 58, mean = 45, and 77 females ages 18 - 65, mean = 46) in a rheumatology practice with severe chronic headache unresponsive to outpatient treatments of medications (NSAIDS, beta blockers, tricyclics, and ergots), biofeedback, low tyramine diet, local injections, and physical therapy were given CES units and instructed to use them for 20 minutes, 4 times daily while continuing their medications. 75 completed the study. Dolimetry using a pressure algometer was performed at 6 active typical "tender" sites just before CES and 1 - 2 months after. Pts were also asked to rate their headache severity on a 1 - 10 scale (1 = no effect, 10 = totally effective in relieving headaches) before CES, at a subsequent visit, and at follow-up. CES proved to be effective in FS-related headache pts. Approximately 50% of FS Pts using CES regularly reported a significant decrease in the frequency and intensity of their headaches. The mean pretreatment headache intensity score was 8.1 (7.8 for males, 8.4 for females). After 1 - 2 months of CES treatment, the mean score was 4.7 (4.5 for males, 4.8 for females). The difference in the mean scores was 3.4 (3.3 for males, 3.6 for females) and there was definite subjective improvement. Dolimetric testing of 450 sites ( 6 per pt) revealed that 42% (189) were improved (had values increased > 1 kg/1.54 cm), 19% (86) were worse, and 39% (175) were unchanged. 8 pts reported absolutely no benefit, 6 stated they were entirely free of headaches, while 15 (20%) reported CES efficacy as a "7", indicating moderate improvement in both frequency and severity of headaches. 38 (51%) rated improvement as a "7" or greater. The author concluded that CES is a helpful adjunct in the treatment of FS pts with headache previously unresponsive to more conventional techniques. No side effects were reported.

66. Solomon, Seymour, Elkind, Arthur, Freitag, Fred et al. Safety and effectiveness of cranial electrotherapy in the treatment of tension headache. Headache. 29:445-450, 1989.

Device: Pain Supressor, 12,000 to 20,000 Hz, 35µS, <4 mA, electrodes across temples

112 pts were enrolled in a multicenter double-blind study of tension headaches. Inclusion criteria was that pts had to have tension headaches requiring analgesic agents for at least 1 year, and at least 4 headaches per month. Pts were excluded with diagnosis of migraine, cluster, or medication-rebound headaches, pregnant women, major physical, mental, or neurological problems, recent history of drug dependency, or implanted electrical devices. Informed consent was obtained. Pts were instructed on the use of the CES device and to treat each headaches for 20 minutes, and if necessary, again for 20 minutes, 20 minutes after the first treatment. The study lasted up to 10 weeks, but terminated after 4 headaches. Pt and physician global evaluations were the primary efficacy variables. Following use of the active unit (N = 57), patients reported an average reduction in pain intensity of approximately 35%. Placebo patients (N = 55) reported a reduction of approximately 18%. The difference was statistically significant (p = 0.01). The active unit was rated as moderately or highly effective by 40% of physicians, and by 36% of pts. Both physicians and pts scored the placebo unit moderately or highly effective for only 16%. The difference in order outcomes was statistically significant. Means of changes in headache severity of the 2 groups was 6.1 pre test to 4.0 post test for the active group (-34.4%, P<0.001), and 6.4 to 5.2 for the placebo group (-18.8%, P<0.001). 17 pts left the study early due to adverse events (2 active, 2 placebo), no effect (3 in each group), non-compliance (1 each), and 5 "others". 6 of 57 in the active group, and 7 of 55 in the placebo group had 1 or more adverse events. The incidence of adverse events was not significantly different between the active and the placebo groups for any of the reported symptoms. The authors concluded that it appears that CES is safe, and should be considered in the management of tension headaches as an alternative to the chronic usage of analgesics.

Muscle Tone / Movement

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.

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.

58. Smith, Ray B., Burgess, A.E., Guinee, V.J., and Reifsnider, L.C. A curvilinear relationship between alcohol withdrawal tremor and personality. Journal of Clinical Psychology. 35(l):199203, 1979.

Device: Neurotone 101, 100 Hz, 2 mS, <1.5 mA, electrodes below each ear

53 male alcoholic pts (mean of 44 years old) who were withdrawing from heavy drinking (mean years' drinking 9.57) were monitored using the Lafayette Instrument Company's Steadiness Tester, hole type, Stop Clock, 1/100 second, and Tone Response hand tremor test along with the MMPI before and after 40 minutes of CES. All pts had been withdrawing for 96 hours or less, and were receiving Librium 25 mg t.i.d., and Dalmain 30 mg at bedtime. 5 pts whose tremor score did not vary more than 1 full second were discarded from the study because the reaction time of the experimenter who controlled the on/off switch on the tremor apparatus was found to vary within this limit. In keeping with an inverted Ucurve theory of responsiveness to CES, high stress pts who tremored very little initially, tremored more following CES, while low stress pts who tremored more initially, tremored less following CES. This could be a major source of confusion in the typical linear statistical analysis involved in CES research. The data fit the researchers' original hypothesis that withdrawing alcoholics would tremor less as their internal stress increased beyond a certain point, as indicated by MMPI score elevations. This may explain the somewhat disconcerting finding that sometimes as few as 80% of known alcoholics tremor during withdrawal, a response heretofore thought of as a diagnostic of the addiction process by many researchers. Drug therapy alone did not alter the stress-tremor relationships found. No side effects were reported.

Pain

6. Clark, Morris S., Silverstone, Lwon, M., Lindenmuth, James et al. An evaluation of the clinical analgesia/anesthesia efficacy on acute pain using the high frequency neural modulator in various dental settings. Oral Surgery, Oral Medicine, Oral Pathology. 63(4):501-505, 1987

Device: high frequency neural modulator, 15 Hz, 4 mA, temporal electrodes, and introral to hand electrodes

50 healthy, nonpregnant dental pts from 16 to 60 years old were separated into an experimental group (N=30), and placebo group (N=20) in this double-blind study to evaluate the effectiveness of CES and peripheral stimulation as a substitute for local anesthesia in various dental procedures, including oral surgery, restorations, tooth extractions, root planing, pulp extirpation, and temporomandibular joint therapy. The degree of pt comfort and satisfaction, their request for local anesthetics, as well as manageability of pain control by the dentist was evaluated. In the experimental group, favorable responses ranged from 0.0% to 92.8%, depending on the procedures. 24 of 30 (80%) CES pts were able to undergo dental procedures without anesthesia. 15 of 20 (75%) of the placebo group required anesthesia. In the operative group, 13 of 14 pts were treated successfully with CES, whereas only 3 of 7 placebo CES pts did well, which is significant at the 0.05 level. All 3 of the CES pts and all 3 placebo CES pts required anesthesia for endodontic procedures. An overall favorable rating of 71.8% was given by the experimental group, whereas an overall favorable response of 8.5% was given by the placebo group. Pts gave favorable comments and all stated that this procedure would be their first choice in future visits. No side effects were reported.

22. Hochman, Richard. Neurotransmitter modulation (TENS) for control of dental operative pain. Journal of the American Dental Association. 116:208-212, 1988.

Device: Neurotransmitter Modulator, electrodes across temples

This is an unblind study of 600 dental procedures over a 1 year period. Although the author refers to the device as a TENS, electrodes were placed across the temples for 10 minutes prior to each procedure which makes the treatment CES by definition. The procedures ranged from vigorous subgingival scaling to endodontic. Results were evaluated for pain control related to procedure type, and the patients' skepticism about the procedure. Results were considered positive if the patient reported greater than 90% reduction in pain and did not request the additional administration of local anesthetic. More than 76% of the pts in all procedures reported 90% or greater success using CES for dental analgesia. For the 71 scaling and prophylactic procedures, more than 83% reported successful pain reduction, and for the 473 restorative procedures, more than 76% reported pain reduction success. For 29 crown preparations, "only" 55% reported success. The majority of pts were skeptical about the procedure but after experiencing CES they were more comfortable with CES than they were with previous dental experiences. The author concluded that from the results obtained during 1 year of treating a variety of pts requiring a broad scope of dental treatments, CES was found to provide a safe, noninvasive, readily acceptable, adjunctive analgesic modality to maintain pt comfort through the majority of dental procedures for most pts. Additional, unexpected positive results were found when the pts reported "feeling more relaxed than usual." No side effects were reported.

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.

66. Solomon, Seymour, Elkind, Arthur, Freitag, Fred et al. Safety and effectiveness of cranial electrotherapy in the treatment of tension headache. Headache. 29:445-450, 1989.

Device: Pain Supressor, 12,000 to 20,000 Hz, 35µS, <4 mA, electrodes across temples

112 pts were enrolled in a multicenter double-blind study of tension headaches. Inclusion criteria was that pts had to have tension headaches requiring analgesic agents for at least 1 year, and at least 4 headaches per month. Pts were excluded with diagnosis of migraine, cluster, or medication-rebound headaches, pregnant women, major physical, mental, or neurological problems, recent history of drug dependency, or implanted electrical devices. Informed consent was obtained. Pts were instructed on the use of the CES device and to treat each headaches for 20 minutes, and if necessary, again for 20 minutes, 20 minutes after the first treatment. The study lasted up to 10 weeks, but terminated after 4 headaches. Pt and physician global evaluations were the primary efficacy variables. Following use of the active unit (N = 57), patients reported an average reduction in pain intensity of approximately 35%. Placebo patients (N = 55) reported a reduction of approximately 18%. The difference was statistically significant (p = 0.01). The active unit was rated as moderately or highly effective by 40% of physicians, and by 36% of pts. Both physicians and pts scored the placebo unit moderately or highly effective for only 16%. The difference in order outcomes was statistically significant. Means of changes in headache severity of the 2 groups was 6.1 pre test to 4.0 post test for the active group (-34.4%, P<0.001), and 6.4 to 5.2 for the placebo group (-18.8%, P<0.001). 17 pts left the study early due to adverse events (2 active, 2 placebo), no effect (3 in each group), non-compliance (1 each), and 5 "others". 6 of 57 in the active group, and 7 of 55 in the placebo group had 1 or more adverse events. The incidence of adverse events was not significantly different between the active and the placebo groups for any of the reported symptoms. The authors concluded that it appears that CES is safe, and should be considered in the management of tension headaches as an alternative to the chronic usage of analgesics.

77. Wilson, L.F. and Childs, A. Cranial electrotherapy stimulation for attentiontotask deficit: A case study. American Journal of Electromedicine. 5(6):9399, 1988.

Device: RelaxPak, 100 Hz, 2 mS, 1 mA, sine wave, bilateral electrodes

4 pts with measurable attentiontotask deficit were studied. 2 had severe pain problems (27 year old female and 30 year old male) but no brain injury, while 2 had suffered from post brain trauma (29 year old male, 25 year old female). One of the pain pts served as placebo control (the 30 year old male) for the other 3, each of whom served as his or her own control. CES was given for 50 minutes per day, 5 days a week for 3 weeks. Pts were pre- and post-tested on standardized cognitive measures (Trail Making Test, Digit Symbol Test, Porteus Mazes, Consonant Trigrams Test, Rey Auditory-Verbal Learning Test, Paced Serial Arithmetic Test) before and following CES, and again 3 weeks later. Pts were also tested on the Profile of Mood States Inventory. The results among the CES treated pts showed striking and significant improvement in the post treatment scores and in the associated extent of the neurological deficit. It was concluded that CES is an effective nondrug alternative in a cognitive rehabilitation model for treating attentiontotask deficit. No side effects were reported.

Spinal Cord Injury

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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