Actively Recruiting
A Randomized Clinical Trial Comparing Active Versus Sham T-PEMF Headband Treatment for Depression
Led by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital · Updated on 2025-08-26
117
Participants Needed
1
Research Sites
114 weeks
Total Duration
On this page
Sponsors
M
Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
Lead Sponsor
I
Innovation Fund Denmark
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
A Randomized Clinical Trial Comparing Active Versus Sham T-PEMF Headband Treatment for Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of moderate to severe depressive episode without psychotic symptoms according to ICD-10 criteria
- Female participants of fertile age must have a negative pregnancy test or be previously sterilized
- Female fertile participants must use safe contraception during the study
- Provided written informed consent to participate in the trial
You will not qualify if you...
- Unable to speak or understand Danish
- Current high risk of suicide (score 2 or more on HAM-D-17 item 3)
- Co-morbid substance dependence
- Bipolar affective disorder
- Psychotic illness
- Dementia or other organic brain diseases
- Presence of any implant such as pacemakers or cochlear implants
- Pregnancy in female participants
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Psychiatric Center Copenhagen
Frederiksberg, Capital Region, Denmark, 2600
Actively Recruiting
Research Team
M
Martin B. Jørgensen, MD DMSc
CONTACT
N
Nana B Sørensen, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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