Clinical Research Directory
Browse clinical research sites, groups, and studies.
A Randomized Clinical Trial Comparing Active Versus Sham T-PEMF Headband Treatment for Depression
Sponsor: Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
Summary
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
Official title: Active Versus Sham Transcranial Pulsed Electromagnetic Field Headband Treatment for Major Depression: a Study Protocol for a Double-blinded Randomized Trial
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
117
Start Date
2024-06-17
Completion Date
2026-08-30
Last Updated
2025-08-26
Healthy Volunteers
No
Conditions
Interventions
Treatment with MoodHeadBand (T-PEMF treatment)
The patients will receive treatment with T-PEMF using a headband containing 20 coils placed symmetrically around the head of the patient. The device delivers 55 Hz magnetic field. Duration of treatment is 30 minutes once a day for 8 weeks.
Inactive treatment with MoodHeadBand (Placebo)
Patients will use an identical device, which does not deliver T-PEMF treatment. The patients will use the headband as the active group for 30 minutes, once a day, for 8 weeks.
Locations (1)
Psychiatric Center Copenhagen
Frederiksberg, Capital Region, Denmark