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Studies

Interventional Recruiting

NCT06005103 on ClinicalTrials.gov

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

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

  • Sponsor: Mental Health Services
  • Collaborators: Innovation Fund Denmark, Danish Medical Association, Doctor Gerhard Linds scholarship, MoodHeadBand Aps
  • Enrollment: 117 (Estimated)
  • Study start: 2024-06-17 (Actual)
  • Primary completion: 2026-08-30 (Estimated)
  • Study completion: 2026-08-30 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • InterventionModelDescription: Patients will receive either active (A) or placebo (B) treatment with the T-PEMF technology using af headband designed for this. The headbands will be chosen randomly from a bag containing a mix of headbands applying either treatment A or B. There will be two bags to choose from, one bag is designated for patients who use antidepressant drugs, the other is designated for patients who do not use antidepressant drugs at the time of inclusion in the study. The firm MoodHeadBand Aps was in control of the randomization procedure, making sure that each bag contained the same amount of headbands applying treatment A and B. An independent person tests the devices to ensure the devices function properly and to ensure that each bag contain an equal amount of active and placebo devices.
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • PrimaryPurpose: Treatment

Brief 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

Conditions

  • Moderate Depression
  • Severe Depressive Episode Without Psychotic Symptoms
  • Recurrent Depressive Disorder, Current Episode Moderate
  • Recurrent Depressive Disorder, Current Episode Severe Without Psychotic Symptoms

Intervention / Treatment

  • Device: Treatment with MoodHeadBand (T-PEMF treatment)
  • Device: Inactive treatment with MoodHeadBand (Placebo)

Primary Outcome Measures

  • Inventory of Depressive Symptomatology (Self-Report) (IDS-SR) (8 weeks)
    The IDS-SR is a 30-item self-report scale for measuring depressive symptoms, with satisfying psychometric features and good correlations with Hamilton-D17 (HAM-D17).

Countries

Denmark

Locations and Investigators

  • Psychiatric Center Copenhagen, Frederiksberg, Denmark (Recruiting)
    • Nana B. Sørensen, MD
    • Nana Brandborg B. Sørensen, MD

Study Officials

  • Martin B. Jørgensen, MD MSc (Principal Investigator) — Psychiatric Center Copenhagen