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

An 8-week, two-armed, randomized-controlled trial that examines the antidepressant effect of treatment with transcranial pulsed electromagnetic fields (T-PEMF) in patients diagnosed with moderate to severe depression using using a new device, the MoodHeadBand (MHB). The participants will use an active or placebo MHB for 30 minutes daily for 8 weeks. Additionally, the following research questions will be answered: 1\. If there is a positive effect on the patients' emotional and non-emotional cognition after 8 weeks of active treatment compared to the sham group and if possible early changes in the emotional cognition can predict the treatment response after 8 weeks of treatment. 1\. If the T-PEMF treatment provides improvement in restorative sleep after 8 weeks of treatment

NCT Number	NCT06005103
Lead Sponsor	Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital Collaborators: Innovation Fund Denmark, Danish Medical Association, Doctor Gerhard Linds scholarship, MoodHeadBand Aps
Conditions	Moderate Depression, Severe Depressive Episode Without Psychotic Symptoms, Recurrent Depressive Disorder, Current Episode Moderate, Recurrent Depressive Disorder, Current Episode Severe Without Psychotic Symptoms
Enrollment	117 participants
Start Date	2024-06-17
Primary Completion	2026-08-30 (estimated)
Study Completion	2026-08-30 (estimated)
Updated on ClinicalTrials.gov	2025-08-26