At-Home tDCS With Remote Supervision Safe, Effective for MDD

Home-based transcranial direct current stimulation (tDCS) with real-time remote supervision was associated with significantly greater symptom improvement and higher clinical remission rates than sham treatment in people with major depressive disorder (MDD), a new study showed.
Treatment response and remission rates were two to three times better with the active treatment in people with first-episode, recurrent, and treatment-resistant MDD, all with no serious adverse events.
Investigators say the findings suggest that tDCS, which is usually performed daily in a clinic, can be used safely at home with supervision.
“Our study demonstrates that at-home tDCS is an acceptable first-line treatment for moderate depression without serious side effects,” study investigator Cynthia Fu, MD, professor of affective neuroscience at King’s College London, London, England, told Medscape Medical News.
While agreeing that the trial results are positive, at least one expert said that more careful remote monitoring of study participants is necessary to prevent possible adverse events.
The findings were published online on October 21 in Nature Medicine.
Large International Trial
More than one third of patients with MDD do not achieve full clinical remission with current first-line treatments, including antidepressants and psychological therapy.
Fu’s earlier research showed that at-home tDCS was feasible and effective, but those trials were small, and none were fully remote.
This larger, international, double-blind, sham-controlled randomized controlled trial included 174 people with at least moderate MDD (70% women; mean age, 38 years). At trial entry, participants could be treatment-free, taking stable antidepressant medication, or undergoing psychotherapy for at least 6 weeks before enrollment.
Participants received remote instruction for their first session on how to affix the headset with the tDCS. For the remainder of the 10-week study, they relied on a workbook for study procedure and could call a 24-hour mobile number if they had any questions.
Participants received active tDCS (2 mA) or sham tDCS (0 mA) for 30 minutes, five times per week for 3 weeks, followed by three sessions per week for 7 weeks. To mimic active stimulation, the sham stimulation included a ramp up from 0 to 1 mA over 30 seconds, followed by ramp down to 0 mA over 15 seconds to cause a tingling sensation.
Researchers had access to remote monitoring to monitor compliance.
Participants in the active tDCS group had a significantly greater decrease in the Hamilton-Depression Rating Scale (HDRS) score than those in the sham group (−9.4 points vs −7.1 points; P = .012). HDRS scores also showed significantly better rates for clinical response (58% vs 38%; P = .017) and remission (45% vs 22%; P = .004).
Adverse events were more common in the active tDCS group — including skin redness, skin irritation, and trouble concentrating. Also, two participants in the active tDCS group reported scalp burns. No serious adverse events were reported.
Increased Supervision?
Commenting on the findings for Medscape Medical News, Noah Philip, MD, professor of psychiatry at The Warren Alpert Medical School of Brown University, Providence, Rhode Island, said that while the results are promising, some of the adverse events deserved special attention.
“You’d never expect to see skin burns in an RCT, and this could indicate some of the challenges of unsupervised at-home use,” he said, adding that additional remote monitoring of study participants may be indicated for at-home use.
In addition to indicating possible improper use of the tDCS device, the burns may have complicated the study blinding, Jonathan Roiser, PhD, professor of neuroscience and mental health, University College London, London, England, in a statement from the UK-based nonprofit and independent Science Media Centre.
“If there was clear skin redness on the forehead, it is possible that the researchers conducting the clinical interviews might also have also guessed the treatment allocation,” Roiser said.
Problems with blinding were also seen with participants, 78% of whom guessed correctly that they were receiving active tDCS. This was a limitation that researchers identified in the study, along with the potential limited generalizability from a study population that was mostly White and had moderate depression.
The study was funded by Flow Neuroscience. Fu reported receiving research grant funding on behalf of the University of East London from Flow Neuroscience, the manufacturer of the tDCS used in the study. She also reported funding from the National Institute of Mental Health, the Baszucki Brain Research Fund Milken Institute, the Rosetrees Trust, the International Psychoanalytic Society, the MRC, NARSAD, and the Wellcome Trust. Philip, Rosier, and Mutz reported no disclosures.
 
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