Home-based tDCS with remote monitoring function is safe and effective for MDD

In patients with major depressive disorder (MDD), home-based transcranial direct current stimulation (tDCS) with real-time remote monitoring resulted in significantly greater symptom improvement and higher clinical remission rates than sham treatment, a new study shows. research has shown.

When treated aggressively in patients with newly diagnosed, relapsed, and treatment-resistant MDD, treatment response and remission rates were two to three times better, with no serious adverse events.

Researchers say the findings suggest that tDCS, which is typically performed daily in the clinic, can be used safely at home with supervision.

“Our study shows that home-based tDCS is an acceptable first-line treatment for moderate depression, without serious side effects,” said the study investigators, from King's College London. said Cynthia Hu, MD, professor of affective neuroscience. Medscape Medical News.

At least one expert, while agreeing that the trial results were positive, said trial participants needed to be more closely monitored remotely to prevent possible adverse events.

It was discovered that Published online on October 21st natural medicine.

Large-scale international clinical trial

More than one-third of patients with MDD fail to achieve complete clinical remission with current first-line treatments such as antidepressants and psychotherapy.

Fu's previous studies showed that home-based tDCS is feasible and effective, but those trials were small and none were done completely remotely.

This large, international, double-blind, sham-controlled, randomized controlled trial enrolled 174 people (70% female, mean age 38 years) with at least moderate MDD. At the time of study entry, participants may be treatment-naive, taking stable antidepressants, or receiving psychotherapy for at least 6 weeks prior to enrollment.

During the first session, participants were remotely instructed on how to secure the headset to the tDCS. For the remaining 10 weeks of the study, participants relied on a workbook for study instructions and were able to call a 24-hour mobile phone number if they had any questions.

Participants received active tDCS (2 mA) or sham tDCS (0 mA) for 30 minutes, 5 times per week for 3 weeks, followed by 3 sessions per week for 7 weeks. To mimic active stimulation, sham stimulation involved ramping from 0 to 1 mA over 30 s and then ramping down to 0 mA over 15 s to induce a tingling sensation.

Researchers had access to remote monitoring to monitor compliance.

Participants in the active tDCS group had a greater reduction in Hamilton Depression Rating Scale (HDRS) scores than participants in the sham group (-9.4 points vs. -7.1 points; P = .012). HDRS scores also showed a significantly better clinical response rate (58% vs. 38%; P = .017) and remission (45% vs. 22%; P = .004).

Adverse events such as skin redness, skin irritation, and decreased concentration were more common in the active tDCS group. Additionally, two participants in the active tDCS group reported scalp burns. No serious adverse events were reported.

Strengthen supervision?

comment on the findings of Medscape Medical NewsDr. Noah Phillip, professor of psychiatry at Brown University's Warren Alpert School of Medicine in Providence, Rhode Island, said the results are promising, but some of the adverse events deserve special attention.

He said, “You would never expect to see skin burns in an RCT. This may indicate some of the challenges of unsupervised home use.” It added that its use may require additional remote monitoring of study participants.

In addition to suggesting possible inappropriate use of the tDCS device, the burns may have complicated the blinding of the study, says the professor of neuroscience and mental health at University College London. Dr. Jonathan Reuther said in a statement from the UK-based non-profit independent scientific organization. media center.

“If there was obvious skin redness on the forehead, the researchers conducting the clinical interview may have also inferred treatment assignment,” Reuther said.

Problems with blinding were also observed among participants, of whom 78% correctly guessed that they were receiving active tDCS. This was a limitation the researchers identified in their study, along with possible limited generalizability from the study population, which was predominantly white and had moderate depression.

This research was funded by Flow Neuroscience. Fu reported that he received research 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, Baszucki Brain Research Fund Milken Institute, Rose Trees Trust, International Psychoanalytic Association, MRC, NARSAD, and the Wellcome Trust. Philippe, Rosier, and Mutz reported no disclosures.