The report is a product of the VA/HSR Evidence Synthesis Program.

The Effectiveness and Risks of Cranial Electrical Stimulation: A Systematic Review

Cranial electrical stimulation (CES) is a non-invasive method of applying low-intensity electrical current to the head. It is related to but distinct from other forms of transcranial electrical stimulation (i.e., electroconvulsive therapy and transcranial direct current stimulation), with different versions of stimulation varying in the placement of electrodes, intensity of the current, and waveform of the current. After an initial burst of research activity in the 1970s and early 1980s, published research on CES slowed, but then accelerated beginning in 2005. One driver for the resurgence in interest in CES has been VA and Department of Defense practitioners that prescribe CES for anxiety, PTSD, insomnia, depression, and headache.

Investigators with VA’s Evidence-based Synthesis Program Center located in West Los Angeles, California searched multiple databases from inception to October 10, 2017 for evidence about the effectiveness and harms of CES for patients with chronic painful conditions, depression, anxiety, PTSD, and insomnia. From 1,924 potentially relevant citations, 28 publications from 26 randomized controlled trials (RCTs) met eligibility criteria for this systematic review and were used to address the following key questions:

• Compared to usual care, what is the effectiveness of CES for chronic pain, depression, anxiety, PTSD, and insomnia?
• Compared to usual care, what are the risks of CES for chronic pain, depression, anxiety, PTSD, and insomnia?

Summary of Review

The principal conclusions of this systematic review are that the evidence is insufficient to support conclusions that CES has clinically important effects on headache, fibromyalgia, neuromuscular pain, depression, PTSD, or insomnia. There is low-strength evidence for a possible beneficial effect of modest size in patients who have anxiety with depression. CES is probably safe, in that no serious side effects have been reported, although reporting bias is present.

Future Research
The biggest research gap and need for future research is adequately blinded studies of sufficient size to detect clinical benefits of moderate size. Given that VA has many patients with pain, depression, anxiety, PTSD, and insomnia – and given that these studies may be relatively short in duration (six months) – it should be very feasible for VA to mount a program of research to answer the questions about effectiveness and safety, and answer these questions within two to four years. It also would be useful to understand whether any possible benefit persists after treatment discontinuation, or whether relapse in symptoms occur, as well as the timing of relapse. If CES is shown to have benefit compared to sham, then comparative effectiveness studies that assess CES compared to other proven active therapies for these conditions is warranted. Finally, long-term studies of safety may be needed.

Reference
Shekelle PG, Cook I, Miake-Lye IM, Mak S, Booth MS, Shanman R, Beroes JM. The Effectiveness and Risks of Cranial Electrical Stimulation for the Treatment of Pain, Depression, Anxiety, PTSD, and Insomnia: A Systematic Review. VA ESP Project #05-226; 2018.

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