NCT06005103Recruiting
A Randomized Clinical Trial Comparing Active Versus Sham T-PEMF Headband Treatment for Depression
Active Versus Sham Transcranial Pulsed Electromagnetic Field Headband Treatment for Major Depression: a Study Protocol for a Double-blinded Randomized Trial
Source: ClinicalTrials.gov · Last updated 26 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 117 (estimated)
- First submitted
- 15 Aug 2023
- Start date
- 17 Jun 2024
- Primary completion date
- 30 Aug 2026
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Diseases
- Depression
- NCT number
- NCT06005103
What you commit to
- Study type: Interventional
- Planned participants: 117
- From 17 Jun 2024 to the primary completion date, 30 Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- The participant has any kind of implant, e.g. pacemakers or cochlear implants.
Other illness
- Bipolar affective disorder.
- Psychotic illness.
- Dementia.
- Other diagnoses of organic brain disease.
Other
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Psychiatric Center Copenhagen Coordinator of this site? Confirm its status | Frederiksberg | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.