Adverse Events Table: Alpha-Stim® CES

In 1974, a review of the research on the safety of cranial electrotherapy stimulation (CES) was commissioned by the FDA and conducted by the National Research Council in Washington, DC. The reviewers concluded that “significant adverse events or complications attributable” to the application of electric current of approximately one milliampere or less for “therapeutic effect to the head” (cranial electrotherapy stimulation) were “virtually nonexistent” (National Research Council, December 14, 1974, p 42). An Alpha-Stim CES device has a 600 microamperes current at the highest setting; 60% of the 1 milliampere current that the National Research Council reviewers for the FDA considered safe. All the studies in this table were conducted using Alpha-Stim CES.

This table lists all adverse events reported in the studies. The 14 Alpha-Stim® CES studies in this table include 2,600 subjects. 2,389 subjects (in CES group, sham/open label group or control/open label group) had treatment while the balance were in the sham or control groups only (N=211). There have been no serious adverse events reported from using Alpha-Stim CES since 1981 when it was introduced to the market.

Principal Investigator Year

 N

Subject Description

Adverse Events
Tan, Gabriel 2011 105 Pain Alpha-Stim CES group: Ears pulse, tingle, sting, itch, ear clips too tight – 12; Legs, tingling. burning, electric shot in feet – 1; Spasms, leg spasms – 1; Burning in buttocks – 1; Ringing in ears – 1; Drowsy, sleepy, fell asleep, relaxing – 7; Dizzy, lightheaded, feeling crooked – 3; Nausea,stomach rolled – 1; Headache, slight headache – 2; Metallic or unusual taste in mouth – 1; Increased pain – 1.Sham CES group: Ears pulse, tingle, sting, itch, ear clips too tight – 6; Head tingles – 1; Legs tingling, electric shot in feet – 1; Spasms, leg spasms – 2; Drowsy, sleepy, fell asleep, relaxing – 4; Dizzy, lightheaded, feeling crooked – 1; Nausea, stomach rolled – 2; Shaky – 1; Heart racing, chest pain – 2; Headache, slight headache – 3; Metallic or unusual taste in mouth – 1; Increased pain – 1.There were no serious study-related adverse events in any phase of this study (p. 292).
Rintala, Diane 2010 13 Pain Alpha-Stim CES group: Pulsing, tickling, tingling in ears – 3; Tender ears – 1; Pins and needles sensation in bladder – 1.Sham CES group:  Drowsiness – 1; Warm ears – 1; Headache – 1.No serious study-related adverse events occurred during this study (p. 4).
Eidelman, William 2009 1000 Anxiety Three (3) subjects out of 1,000 individuals (0.3%) were unable to tolerate the CES treatment due to vertigo (p. 83).
Holubec, Jerry 2009 525 Pain No negative adverse events were observed by any member of the clinic staff or reported by patients (p. 83).
Mellon, Ronald R. 2009  21 Anxiety and Depression After the third CES session, one subject reported increased levels of agitation secondary to treatment and was removed from the study(p. 11).
Bystritsky, Alexander 2008 12 Anxiety Two subjects dropped out of the study because of dizziness and one dropped  out of study because of headache, (p. e3).
Strentzsch, Julie A.2008 42 Anxiety Alpha-Stim CES Group: One subject from the active CES group reported increased auditory hallucinations but remained in the study with no further problems (p. 56).Sham CES Group: Two subjects from the sham group reported headaches from treatment (p. 56).
Kulkarni, AD 2001

20

Pain No negative adverse events were reported by patients (p.102).
Lichtbroun, Alan 2001

60

Pain Subjects experienced no significant adverse events (p.76).
Schroeder, MJ 2001

12

“Normal” subjects No adverse events were reported (p. 2081).
Tyers, DC 2001

60

Pain No negative adverse events from treatments given in the study were reported…when asked at the end of the study (p.40).
Winick, Reid 1999

33

Anxiety No detectable adverse effects were noted in any of the subjects undergoing CES treatment (p.54).
Overcash,   Stephen 1999

197

There was no reported side-effects (either short or long term) from CES (p. 51).

Note: To be included in the table of studies, the study must have been done using Alpha-Stim CES, must include a specific statement on adverse events and must be a primary source.

TOTAL ADVERSE EVENTS IN 14 ALPHA-STIM CES STUDIES ABOVE

Adverse Event

CES < 1%

Sham < 1%

Ears tender, tingle, sting, itch, ear clips too tight*  16 7
Vertigo*  14 1
Drowsy, sleepy, relaxing  7 5
Headache*  3 3
Skin Irritation, earlobes  3 0
Nausea*  3 0
Agitation/Anger  2 0
Tinnitus  2 0
Metallic taste in mouth  2 1
Increased pain  1 1
Legs tingling, burning  1 1
Leg spasms  1 2
Head tingles  0 1
Pins and needles in bladder  1 0
Burning in Buttocks  1 0
Auditory hallucinations  1 0
Heavy feeling*  1 0
Heart Racing, Chest Pain  0  2
 TOTAL  59  24

Comments: Vertigo, headache and nausea occur when the current is set too high for the individual. These symptoms disappear when the current is decreased. Tingling, stinging and itching of ears are a response to the current and will disappear when the current is decreased.

Note: To be included in the table of studies, the study must have been done using Alpha-Stim CES, must include a specific statement on adverse events and must be a primary source.

References

Bystritsky, A., Kerwin, L. and Feusner, J. A pilot study of cranial electrotherapy stimulation for generalized anxiety disorder. Journal of Clinical Psychiatry, 69:412-417, 2008.

Eidelman, W. S. Control of cigarette cravings with cranial electrotherapy stimulation. The Townsend Letter for Doctors, 311(6): 81-85, 2009.

Holubec, J. T. Cumulative Response from Cranial Electrotherapy Stimulation (CES) for Chronic Pain. Practical Pain Management, 9(9):80-83, 2009.

Kim, H. J., Kim, W. Y., Lee, Y. S., Chang, M. S., Kim, Jae, H., and Park, Y. C. The effect of cranial electrotherapy stimulation on preoperative anxiety and hemodynamic responses. Korean Journal of Anesthesiology, 55(6): 657- 661, 2008.

Kirsch, D. The Science Behind Cranial Electrotherapy Stimulation (2nd edition).  Edmonton, Alberta, Canada: Medical Scope Publishing.

Kulkarni, Arun D. and Smith, Ray B. The Use of Microcurrent Electrical Therapy and Cranial Electrotherapy Stimulation in Pain Control. Clinical Practice of Alternative Medicine. 2(2):99-102, 2001.

Lichtbroun, A. S. The treatment of fibromyalgia with cranial electrotherapy stimulation. Journal of Clinical Rheumatology, 7(2):72-78, 2001.

Mellen, R. R. and Mackey, W. Reducing sheriff’s officers’ symptoms of depression using cranial electrotherapy stimulation (CES): a control experimental study. The Correctional Psychologist, 41(1): 9-15, 2009.

Overcash, Stephen J. A retrospective study to determine the effect of cranial electrotherapy stimulation CES) on patients suffering from anxiety disorders, American Journal of Electromedicine, 16(1):49-51,1999.

Rintala, D. H., Tan, G., Willson, P., Bryant, M. S and Lai, E. C. H. Feasibility of Using Cranial Electrotherapy Stimulation for Pain in Persons with Parkinson’s Disease. Parkinson’s Disease, 2010.

Schroeder, M.J., and Barr, R.E. Quantitative analysis of electroencephalogram during cranial  electrotherapy stimulation. Clinical Neurophysiology. 112:2075-2083, 2001.

Strentzsch, J. A. An examination of cranial electrotherapy stimulation (CES) on alpha-amylase levels, cortisol levels and state-trait anxiety scores in the chronically mentally ill.  Doctoral dissertation, Saint Mary’s University, San Antonio, Texas, 2008.

Tan, G., Rintala, D., Jensen, M. P., Richards, J. S., Holmes, S. A., Parachuri, R., Lashgari-Saegh, S. and Price, L. R. Efficacy of cranial electrotherapy stimulation for neuropathic pain following spinal cord injury: a multi-site randomized controlled trial with a secondary 6-month open-label phase. The Journal
of Spinal Cord Medicine
, 34(3):285-296, 2011.

Tyers, S. and Smith, R. B. A comparison of cranial electrotherapy stimulation alone or with chiropractic therapies in the treatment of fibromyalgia. The American Chiropractor, 23(2):39-41, 2001.

Voris, M. D. An investigation of the effectiveness of cranial electrotherapy stimulation in the treatment of anxiety disorders among outpatient psychiatric patients, impulse control parolees and pedophiles. Delos Mind/Body Institute Newsletter, Dallas and Corpus Cristi, Texas, 1995.

Winick, R. L. Cranial electrotherapy stimulation (CES): a safe and effective low cost means of anxiety control in a dental practice. General Dentistry, 47(1):50-55,1999.