Recruiting

A Randomized Clinical Trial Comparing Active Versus Sham T-PEMF Headband Treatment for Depression

ClinicalTrials.gov IDNCT06005103

PhaseNA

Enrollment117

SponsorMental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

Age18 Years

SexALL

I'm interested View official listing

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

About this study

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

Interventions

Device: Treatment 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.
Device: Inactive 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.

Primary outcomes

Inventory of Depressive Symptomatology (Self-Report) (IDS-SR) (8 weeks)

Eligibility information

Inclusion Criteria: * 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 Criteria: * 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

Study locations

Psychiatric Center Copenhagen, Frederiksberg, Capital Region 2600 Denmark

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.