Using a headband to treat moderate to severe depression

Active Versus Sham Transcranial Pulsed Electromagnetic Field Headband Treatment for Major Depression: a Study Protocol for a Double-blinded Randomized Trial

This study is testing whether a headband that uses magnetic fields can help people with moderate to severe depression feel better over eight weeks.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 117 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital (other)
• Locations: 1 site (Frederiksberg, Capital Region)
• Trial ID: NCT06005103 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of transcranial pulsed electromagnetic fields (T-PEMF) on patients with moderate to severe depression using a device called the MoodHeadBand (MHB). Over an 8-week period, participants will use either the active MHB or a placebo for 30 minutes daily. The study aims to assess the antidepressant effects, cognitive improvements, and potential benefits for restorative sleep associated with T-PEMF treatment. Participants will be monitored through weekly follow-ups and surveys to evaluate their depression severity and treatment response.

Who should consider this trial

Good fit: Ideal candidates are adults diagnosed with moderate to severe depression without psychotic symptoms who can provide informed consent.

Not a fit: Patients with a high risk of suicide, bipolar disorder, or other significant mental health conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a non-invasive and effective option for managing moderate to severe depression.

How similar studies have performed: Previous studies in Denmark have shown significant antidepressant effects of other T-PEMF devices, suggesting potential success for this approach.

Eligibility criteria

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

Where this trial is running

Frederiksberg, Capital Region

• Psychiatric Center Copenhagen — Frederiksberg, Capital Region, Denmark (RECRUITING)

Study contacts

• Principal investigator: Martin B. Jørgensen, MD MSc — Psychiatric Center Copenhagen
• Study coordinator: Martin B. Jørgensen, MD DMSc

Conditions: Moderate Depression, Severe Depressive Episode Without Psychotic Symptoms, Recurrent Depressive Disorder, Current Episode Moderate, Recurrent Depressive Disorder, Current Episode Severe Without Psychotic Symptoms, Randomized Controlled Trial, Depression, Transcranial Pulsed Electro-Magnetic Fields, Psychiatry