The unsupervised, at-home use of existing direct transcranial stimulation (tDCS) was nothing more than a sham to treat a primary depressive episode, a randomized trial showed.
The PSYLECT trial of 210 adults in Brazil showed no differences in mean changes in Hamilton Depression Rating Scale-17 (HDRS-17) scores over 6 weeks across three groups: a double-active group, a tDCS-only group, and a double-sham group (8.2, 8.5, and 7.7, respectively), Andre Brunoni, MD, PhD, of the University of São Paulo Medical School in Brazil, and colleagues reported in JAMA Psychiatry.
“It seems that tDCS might take more time than 6 weeks to develop clinically meaningful effects,” Brunoni told MedPage Today in an email. “Therefore, it should not be used, particularly as monotherapy, in more severe episodes in which a faster response is necessary.”
Better treatments for major depression are sorely needed, the researchers said. Unlike transcranial magnetic stimulation and electroconvulsive therapy, they said, tDCS is portable, inexpensive, and has minimal side effects. The problem is that it needs to be applied daily, which can be limited by clinical worker availability and patient ability to come into the clinic.
Thus, home use of tDCS may simply be a smart treatment option, and at least one small study showed promising effects in the realm of depression, the researchers said. In fact, tDCS wearables have been evolved and adopted, but there is no rigorously controlled testing of their effectiveness.
In addition, clinical studies of tDCS have yielded combined results. An earlier trial by Brunoni and colleagues published in the New England Journal of Medicine showed that tDCS beat placebo in treating depression (although it may simply not show noninferiority to antidepressant). escitalopram [Lexapro]) in a clinical setting. However, another study Brunoni participated in, published in The Lancet, showed that tDCS is no greater than sham stimulation when combined with a selective serotonin reuptake inhibitor to treat primary depressive disorder.
Brunoni and colleagues conducted the PSYLECT trial, which involved an additional 210 people in Brazil (86% female, mean age 38. 9 years, 72% Caucasian) with an HDRS-17 score greater than 16 and access to a smartphone and the internet at home. Exclusion Criteria There were any psychiatric disorders other than anxiety, any neurological or clinical disorders, and any contraindications to tDCS.
Participants were randomly assigned to one of 3 home-use organizations: a dual-activity organization involving tDCS and a virtual intervention (64), a tDCS-only organization (73), and a dual-simulation, sham stimulation, and virtual placebo organization (73). .
For the stimulation intervention, participants were given a device that delivered 2 mA stimulation and asked to perform 30-minute sessions a day for 15 consecutive days of the week. Over the next 3 weeks, participants switched to bi-weekly sessions.
For the dual-activity group, the additional virtual intervention consisted of stimulation and was based on behavioral therapy. The virtual placebo consisted of relaxed internet browsing using the same interface as the active intervention. The sham stimulation was 1 mA for 90 seconds.
Response rates, a secondary end result of the study, occurred between teams (31% for dual activity, 36% for tDCS only, and 38% for dual simulation), as did remission rates (14%, 18%, and 21%). respectively), the researchers found.
The findings cannot be explained by poor adherence or misuse of the tDCS device at home, nor have they caused disorders in previous at-home trials, the researchers said. The home environment may have decreased the placebo response, but the effects were also similar to previous in situ trials of tDCS, they noted.
Brunoni noted that the short duration of the trial is a key limitation of the study, as it is likely too short to produce significant clinical effects. Other limitations stem from the lack of precision in electrode positioning and the heterogeneous effects of virtual intervention modules.
He and his colleagues concluded that the findings suggested that tDCS was useless for primary depressive episodes, that is, as a home intervention.
“The main indication of tDCS continues to be for mild depressive disorder, in which [it] is possible to wait several weeks for antidepressant effects,” Brunoni said. He added that tDCS “could be an interesting alternative, for instance, coupled with other non-pharmaceutical interventions, such as physical activity.”
Michael DePeau-Wilson is a reporter on MedPage Today’s corporate and investigative team. It covers psychiatry, long covid, and infectious diseases, among applicable U. S. clinical news. U. S.
The trial was funded by a grant from the São Paulo State Research Foundation. Flow Neuroscience donated the budget used to pay the clinical and study staff directly involved in the trial.
The authors reported monetary relationships with Flow Neuroscience, Sooma, Brainsway Inc. , Mag