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

August 19, 2025 updated by: Martin Balslev Jørgensen, Mental Health Services in the Capital Region, Denmark

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to clarify whether daily treatment over eight weeks with weak pulsating electromagnetic fields (T-PEMF) can achieve a safe effect on depression compared to the same treatment with a placebo T-PEMF. The study will furthermore explore possible effects on cognition and the hypothesized sleep-ameliorating effect of T-PEMF. Previous Danish studies have shown a significant antidepressant effect of other T-PEMF devices in the treatment of patients with depression.

The study is designed as a blinded, randomized study where active treatment is compared with inactive (placebo) treatment. At the same time, possible side effects in the use of the headband (MoodHeadBand, MHB) are investigated.

The project was initiated June 2024. Patients consecutively referred are asked after an initial interview whether they wish to participate in the study. If they give informed consent to this, they will be randomized to active or placebo treatment. The treatment itself takes place at home, 30 minutes once a day, for 8 weeks. "Treatment as usual" takes place in parallel to the study treatment, and consists of psychotherapy in a group or individually and antidepressive medications. Follow-ups will be conducted weekly either as visits at the clinic, via videocall or as telephone calls. The participants will receive weekly surveys they are encouraged to fill out prior to the weekly follow-ups. The severity of the depression, including its symptomatology will be examined weekly during the study, the cognitive test-battery is applied at baseline, week 1 and at the final visit, the patients sleep-pattern and possible disturbances are examined via the weekly surverys.

No significant side effects have been registered when using the same type of electromagnetic field treatment in the previous Danish studies. It has also been shown that it is possible to carry out the treatment at home without significant problems.

Study Type

Interventional

Enrollment (Estimated)

117

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Denmark
    • Capital Region
      • Frederiksberg, Capital Region, Denmark, 2600
        • Recruiting
        • Psychiatric Center Copenhagen
        • Contact:
        • Sub-Investigator:
          • Nana Brandborg B. Sørensen, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: (A) Patients diagnosed with moderate to severe depression without psychotic symptoms

In total, 48 patients will be allocated to this arm.

(In total, 117 patients will be included in the study. Data for the initial 21 patients included in the study could not be used to assess the antidepressant effect, why an increased number of participants was needed to secure the power for the trial. The technical difficulties have been addressed)
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.
Sham Comparator: (B) Patients diagnosed with moderate to severe depression without psychotic symptoms

In total, 48 patients will be allocated to this arm.

(In total, 117 patients will be included in the study. Data for the initial 21 patients included in the study could not be used to assess the antidepressant effect, why an increased number of participants was needed to secure the power for the trial. The technical difficulties have been addressed)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inventory of Depressive Symptomatology (Self-Report) (IDS-SR)
Time Frame: 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).
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hamilton-D17 (HAM-D17)
Time Frame: 8 weeks
A scale measuring depressive symptoms. Will be applied at baseline and at the end point
8 weeks
Hamilton-D6 (HAM-D6)
Time Frame: 8 weeks
A scale measuring depressive symptoms. Will be applied at baseline and at the end point.
8 weeks
WHO-5
Time Frame: 8 weeks
This Well-Being Index consists of five items that are scored on a frequency response scale from "none of the time" (0) to "all of the time" (5).
8 weeks
Udvalget for Kliniske Undersøgelser scale (UKU-24)
Time Frame: 8 weeks
Side effects are assessed by the UKU-24 scale, including free text comments. Side effects will be assesed at week 1, 2, 4, 6 and at the end point.
8 weeks
Facial Expression and Recognition Test (FERT)
Time Frame: 8 weeks
A test that assesses the patients recognition of - and attention to facial expressions as a part of the cognitive test battery that explores the patients "hot" cognition.
8 weeks
Emotional Categorization and Memory Test (ECMT)
Time Frame: 8 weeks
A test that assesses the patient' self-referential memory with emotion laded words as a part of the cognitive test battery that explores the patients' "hot" cognition.
8 weeks
Screening of cognitive impairment in Psychiatry (SCIP)
Time Frame: 8 weeks
A screening tool used to assess cognitive performance in psychiatric patients. The test includes List learning, delayed list learning, verbal fluency, visuomotor tracking tests. Explores the patients' "cold" cognitive mechanisms.
8 weeks
Trail Making Test B (TMT-B)
Time Frame: 8 weeks
A test that assesses the patients' visual attention and ability to switch tasks. Explores the patients' "cold" cognitive mechanisms.
8 weeks
Sleep diary
Time Frame: 8 weeks
The diary explores the patients sleep pattern and quality of sleep.
8 weeks
Quick Inventory of Depressive Symptomatology
Time Frame: 8 weeks
A quick-version of the IDS questionnaire, that consists of 16 questions. Patients fill this assesment on a weekly basis during the study.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mental Health Services in the Capital Region, Denmark

Collaborators

Innovation Fund Denmark
Danish Medical Association
Doctor Gerhard Linds scholarship
MoodHeadBand Aps

Investigators

  • Principal Investigator: Martin B. Jørgensen, MD MSc, Psychiatric Center Copenhagen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 17, 2024

Primary Completion (Estimated)

August 30, 2026

Study Completion (Estimated)

August 30, 2026

Study Registration Dates

First Submitted

August 15, 2023

First Submitted That Met QC Criteria

August 15, 2023

First Posted (Actual)

August 22, 2023

Study Record Updates

Last Update Posted (Estimated)

August 26, 2025

Last Update Submitted That Met QC Criteria

August 19, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2215332

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

It is not possible to share individual participant data due to GDPR. Anonymised data after publishing might be available per request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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