RecruitingNot ApplicableNCT06005103

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


Sponsor

Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

Enrollment

117 participants

Start Date

Jun 17, 2024

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a wearable headband that uses gentle magnetic pulses (called T-PEMF therapy) to treat moderate-to-severe depression — comparing the real device to a fake (sham) device to see if it works. **You may be eligible if:** - You have been diagnosed with a moderate-to-severe depressive episode without psychotic symptoms - You have given written consent to participate - If you are a woman of childbearing age: you have a negative pregnancy test and use effective contraception **You may NOT be eligible if:** - You cannot speak or understand Danish - You have a high suicide risk - You have a substance use disorder, bipolar disorder, psychosis, dementia, or other brain disease - You have any implanted device such as a pacemaker or cochlear implant - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICETreatment 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.

DEVICEInactive 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

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NCT06005103


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