A Randomized Clinical Trial Comparing Active Versus Sham T-PEMF Headband Treatment for Depression
Key facts
- Where
- Frederiksberg, DenmarkSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Where in Denmark
- Psychiatric Center CopenhagenFrederiksberg, DenmarkTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Trial code
- NCT06005103
- Record updated
- 26 August 2025
- Original description
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).Read full original descriptionShow less
Active Versus Sham Transcranial Pulsed Electromagnetic Field Headband Treatment for Major Depression: a Study Protocol for a Double-blinded Randomized Trial
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
Inclusion: Meeting the diagnostic criteria for moderate to severe depressive episode without psychotic symptoms according to the International Classification of Diseases and Related Health Problems 10th Revision (ICD-10)(The ICD-10 Classification of Mental and Behavioural Disorders: Diagnostic Criteria for Research 1993); Female participants: Females in the fertile age must deliver a negative pregnancy test, or previously have been sterilized; Female fertile participants: They must use safe contraceptive methods to be included in the study, and during the whole study; Has given written, informed consent to the trial.
Exclusion: The participant has any kind of implant, e.g. pacemakers or cochlear implants; Bipolar affective disorder; Psychotic illness; Dementia; Other diagnoses of organic brain disease; Inability to speak or understand the Danish language; A current high risk of suicide (a score of 2 or more on the HAM-D-17 item 3); A co-morbid substance dependence; Female participants: Pregnancy.