Active Versus Sham Transcranial Pulsed Electromagnetic Field Headband Treatment for Major Depression: a Double-blinded Randomized Trial

What this Trial Is About

Researchers are evaluating the antidepressant effects of daily treatment using transcranial pulsed electromagnetic fields (T-PEMF) delivered by a new device called the MoodHeadBand (MHB) in patients diagnosed with moderate to severe depression without psychotic symptoms. This randomized-controlled trial aims to compare active T-PEMF treatment to a placebo device over an 8-week period. The study will also explore changes in emotional and non-emotional cognition and assess if T-PEMF improves restorative sleep in participants. Participants are randomly assigned to use either an active MoodHeadBand delivering T-PEMF or an identical placebo device that delivers no electromagnetic treatment. Both groups will use their assigned headband for 30 minutes daily at home for 8 weeks. Treatment as usual, including psychotherapy and antidepressant medications, continues alongside the study intervention. Weekly follow-ups are conducted through clinic visits, video calls, or phone calls, with participants completing weekly surveys to monitor symptoms and sleep patterns. During the study, the severity of depression will be assessed weekly using validated scales, while cognitive testing occurs at baseline, week 1, and the final visit. Researchers will measure the primary outcome using the Inventory of Depressive Symptomatology (Self-Report) at 8 weeks. Secondary measures include various depression rating scales, cognitive tests, and sleep diaries. The study also monitors possible side effects and treatment adherence throughout the participation period, which lasts 8 weeks.

A Randomized Clinical Trial Comparing Active Versus Sham T-PEMF Headband Treatment for Depression