A Randomized Clinical Trial Comparing Active Versus Sham T-PEMF Headband Treatment for Depression
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Moderate Depression, Severe Depressive Episode Without Psychotic Symptoms, Recurrent Depressive Disorder, Current Episode Moderate, Recurrent Depressive Disorder, Current Episode Severe Without Psychotic Symptoms
In brief
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
Key facts
- Study ID
- NCT06005103
- Run by
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- People needed
- 117
- Starts
- 2024-06-17
- Expected to finish
- 2026-08-30
- Last updated by the study team
- 2025-08-26
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
- Bipolar affective disorder.
- Psychotic illness.
- Dementia.
- Other diagnoses of organic brain disease.
- The participant has any kind of implant, e.g. pacemakers or cochlear implants.
- Female participants: Pregnancy
Where it is running
- Psychiatric Center Copenhagen — Frederiksberg, Capital Region, Denmark (enrolling)
Full record on ClinicalTrials.gov
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