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

NCT06005103 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 117

Last updated 2025-08-26

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Innovation Fund Denmark

    collaborator INDIV

  • Danish Medical Association

    collaborator OTHER

  • Doctor Gerhard Linds scholarship

    collaborator UNKNOWN

  • MoodHeadBand Aps

    collaborator UNKNOWN

  • Mental Health Services in the Capital Region, Denmark

    lead OTHER

Principal Investigators

  • Martin B. Jørgensen, MD MSc · Psychiatric Center Copenhagen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-17
Primary Completion
2026-08-30
Completion
2026-08-30

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06005103 on ClinicalTrials.gov