Durable Medical Equipment Section - Cranial Electrostimulation Therapy (CES)

IMPORTANT REMINDER

This Medical Policy has been developed through consideration of medical necessity, generally accepted standards of medical practice, and review of medical literature and government approval status.

Benefit determinations should be based in all cases on the applicable contract language. To the extent there are any conflicts between these guidelines and the contract language, the contract language will control.

The purpose of medical policy is to provide a guide to coverage. Medical Policy is not intended to dictate to providers how to practice medicine. Providers are expected to exercise their medical judgment in providing the most appropriate care.

DESCRIPTION

Cranial electrostimulation therapy (CES) involves passing small electrical impulses across the head, usually from electrodes placed on or near both ears. CES is used to treat a variety of chronic conditions including, but not limited to treatment of stress, alcoholism and drug addiction, headache, cognitive dysfunction in head injured patients, psychiatric conditions, reflex sympathetic dystrophy and multiple sclerosis.

The food and drug administration (FDA) granted 510(k) approval for three different stimulators: Alpha-Sim® 100, Alpha-Stim® SCS (stress control system), and Alpha-Stim® PPM (personal pain manager). The models 100 and CSC are primarily used for cranial stimulation. The AlphaStim PPM is indicated for treatment of pain conditions, and is addressed in Regence Medical Policy, DME-11, Electrical Stimulation Devices for Home Use.

POLICY/CRITERIA

Cranial electrostimulation therapy is considered investigational for all indications, including but not limited to treatment of:

1. Alzheimer’s disease
2. Anxiety
3. Chemical dependence / substance abuse
4. Chronic pain related to spinal cord injury
5. Cognitive dysfunction
6. Depressive symptoms
7. Fibromyalgia
8. Headache
9. Smoking cessation
10. Sleep disturbances
11. Stress related conditions
12. Tinnitus

POSITION STATEMENT

CES has not been established as an effective treatment for any condition. 

•  The published randomized controlled trials comparing CES to sham devices are unreliable and do not allow conclusions about the true treatment effects of CES.
• There are no long-term data from well-designed randomized controlled clinical trials demonstrating the impact of CES on health outcomes for the above indications.
• As most studies examined different and unrelated medical conditions, the current literature does not permit meaningful evaluation and comparison of treatment parameters. As a consequence, there are no standardized optimal short- or long-term CES treatment protocols for the indicated conditions.

Effectiveness

A number of randomized controlled studies explored the efficacy of CES for a variety of conditions, including Alzheimer’s disease, smoking cessation, chronic pain related to spinal cord injury, anxiety in patients receiving dental care, chemical dependence, sleep disturbances, depressive symptoms, fibromyalgia, and tinnitus. Overall, data from these studies are unreliable due to the following limitations:

• Small study populations, less than 100 patients total, (1, 2, 4-10) limit our ability to rule out the role of chance as an explanation of study findings.
• Follow-up of study subjects was over a short period of time, less than 6 months, so medium and long-term effects of CES treatment are unknown (1-10).
• Use of co-therapies such as fibromyalgia medications (8) and antidepressants (4) were allowed but not adequately addressed in the analysis, potentially confounding the findings. In some instances the status of the patients regarding concurrent treatments was not addressed at all (6).
• Randomization methods were not clearly stated (1, 6, 10) or weak methods of randomization were used (4, 8, 9). The latter did not provide sufficient evidence to support claims of adequate randomization, such as comparison of the active treatment and sham groups at study baseline. 
• Some of the study designs allowed for treatment crossover after a specified wash-out period (4, 10). As medium- and long-term effects of CES have not been evaluated or established, the appropriate wash-out period is difficult to define.  In addition, crossover study populations were not necessarily subject to the same treatment parameters as active groups, undermining valid comparisons (10).
• The use of flawed data analysis methodologies, such as deleting a subset of patients based on their diagnosis after they had been randomized and treated (6), renders the study findings unreliable.
• Overall, the trials did not adequately explain the clinical significance of the changes observed in their outcomes of interest.
• The treatment parameters used in the studies varied in their frequency, intensity, duration of individual CES sessions, as well as the overall treatment duration. Only two studies looked at how changes in treatment parameters influenced the same outcome of interest. They did not find a significant difference between the two, but this study was subject to other major design flaws (1, 2).

Safety

Only two studies included information on adverse effects (4, 5). In both of these studies, the CES treatment was well tolerated.

References

1. Scherder E, Knol D, van Someren E. et al. Effects of low-frequency cranial electrostimulation on the rest-activity rhythm and salivary cortisol in Alzheimer’s disease. Neurorehabil Neural Repair 2003;17(2):101-8
2. Scherder EJ, van Tol MJ, Swaab DF. High-frequency cranial electrostimulation (CES) in patients with probable Alzheimer's disease. Am J Phys Med Rehabil 2006;85(7):614-8
3. Pickworth WB, Fant RV, Butschky MF et al. Evaluation of cranial electrostimulation therapy on short-term smoking cessation. Biol Psychiatry 1997;42(2):116-21
4. Capel ID, Dorrell HM, Spencer EP et al. The amelioration of the suffering associated with spinal cord injury with subperception transcranial electrical stimulation. Spinal Cord 2003;41(2):109-17
5. Winick RL. Cranial electrotherapy stimulation (CES): a safe and effective low cost means of anxiety control in a dental practice. Gen Den 1999;47(1):50-5
6. Schmitt R, Capo T at al. Cranial Electrotherapy Stimulation as a treatment for anxiety in chemically dependent persons. Alcohol Clin Exp Res 1986;10(2):158-60 
7. Rose KM, Taylor AG at al. Effects of cranial electrical stimulation on sleep disturbances, depressive symptoms, and caregiving appraisal in spousal caregivers of persons with Alzheimer’s disease. Appl Nurs Res 2009;22(2):119-25
8. Lichtbroun AS, Mei-Ming C at al. The treatment of fibromyalgia with cranial electrotherapy stimulation. J Clin Psychiatry 1984;45(2):60-1, 62-3
9. Kapkin O, Satar B at al. Transcutaneous electrical stimulation of subjective tinnitus. A placebo-controlled, randomized and comparative analysis. ORL J Otorhinolaryngol Relat Spec 2008;70(3):156-61
10. Tan G, Rintala DH at al. Using cranial electrotherapy stimulation to treat pain associated with spinal cord injury. J Rehabil Res Dev 2006;43(4):461-74

Cross References

Electrical Stimulation Devices for Home Use, Regence Medical Policy Manual, DME, Policy No. 11

DME Section Table of Contents