The Alpha-Stim Anxiety Insomnia and Depression (AID) device was found to be safe and acceptable for the treatment of major depression, but it was not more effective than sham treatment. These findings were published in The Lancet Psychiatry.
The Alpha-Stim AID device is a cranial electrostimulation apparatus that attaches to both earlobes by metal clips and is recommended for 20-60 minutes daily use for the treatment of anxiety, insomnia, and depression. The device in this study generated bipolar, asymmetric, rectangular waves at a frequency of 0.5 Hz and a current intensity at its lowest therapeutic dose of 100 µA.
The Alpha-Stim-D trial was a noncommercial, multicenter, randomly assigned, parallel group, double-blind trial conducted at 25 primary care practices in the United Kingdom. Patients (N=236) with moderate to severe depression were randomly assigned in a 1:1 ratio to receive 8 weeks of daily treatment for 60 minutes with active (n=118) or sham (n=118) Alpha-Stim AID. The primary outcome for this study was the change in GRID version of the 17-item Hamilton Depression Rating Scale (GRID-HDRS-17) scores from baseline to 16 weeks. Response to treatment was defined as a 50% decrease in GRID-HDRS-17 score from baseline and remission with a GRID-HDRS-17 score of less than 7 points.
The active and sham cohorts comprised patients with mean ages of 37.1 (SD, 15.1) and 38.9 (SD, 15.5) years, 63% and 69% were women, 90% and 80% were White British or Irish, 30% and 25% had a physical disability, 87% and 86% took antidepressants in the previous 6 weeks, and baseline GRID-HDRS-17 scores were 17.4 (SD, 5.5) and 16.4 (SD, 5.4) points, respectively.
Among both study cohorts, the change in GRID-HDRS-17 score were -5.1 and -5.9 points at 4 weeks, -5.9 to -6.8 points at 8 weeks, and -5.9 to -6.5 points at 16 weeks. The mean difference in the change in GRID-HDRS-17 scores between groups did not differ significantly at 4 (mean change difference [MCD], 0.8; P =.35), 8 (MCD, 0.9; P =.25), or 16 (MCD, 0.6; P =.46) weeks.
At 16 weeks, 33% of the active and 41% of the sham device recipients responded to treatment (P =.27) and 30% and 42% were in remission (P =.092), respectively.
For secondary outcomes, the sham device was preferred over the active device for improving Patient Health Questionnaire-9 (PHQ-9) scores at weeks 4 (P =.048) and 16 (P =.025), 7-item Generalized Anxiety Disorder scale (GAD-7) scores at week 4 (P =.031), and 5-level EQ-5D (EQ-5D-5L) scores at week 16 (P =.049).
The adherence rates were similar between active and sham device users (73%). Overall, 12% of men and 5% of women reported an adverse event with active device use and 9% of men and 6% of women reported an adverse event with sham device use. The most common adverse events were headache (3%), tinnitus (1%), and anxiety (1%).
This study was not designed to evaluate clinical efficacy.
Study authors concluded, “Alpha-Stim AID CES at a daily dose of 100 μA for 8 weeks was well tolerated and safe, but we found no evidence to support its clinical effectiveness in patients with moderate to moderately severe primary major depression.”
Disclosure: An author declared affiliations with industry. Please refer to the original article for a full list of disclosures.
Morriss R, Patel S, Boutry C, et al. Clinical effectiveness of active Alpha-Stim AID versus sham Alpha-Stim AID in major depression in primary care in England (Alpha-Stim-D): a multicentre, parallel group, double-blind, randomised controlled trial. Lancet Psychiatry. 2023;S2215-0366(23)00007-X. doi:10.1016/S2215-0366(23)00007-X