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

NCT06005103 | Recruiting DMC

• 1 other identifier: 2215332
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

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

Keywords

Randomized Controlled Trial; Depression; Transcranial Pulsed Electro-Magnetic Fields (T-PEMF); Psychiatry; Cognition; Sleep

Outcome Measures

Primary Outcomes (1)

• Inventory of Depressive Symptomatology (Self-Report) (IDS-SR)

  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 Outcomes (10)

• Hamilton-D17 (HAM-D17)

  8 weeks

• Hamilton-D6 (HAM-D6)

  8 weeks

• Quick Inventory of Depressive Symptomatology

  8 weeks

• WHO-5

  8 weeks

• Facial Expression and Recognition Test (FERT)

  8 weeks

Study Arms (2)

(A) Patients diagnosed with moderate to severe depression without psychotic symptoms

EXPERIMENTAL

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)

(B) Patients diagnosed with moderate to severe depression without psychotic symptoms

SHAM COMPARATOR

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)

Interventions

Treatment with MoodHeadBand (T-PEMF treatment) DEVICE

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.

(A) Patients diagnosed with moderate to severe depression without psychotic symptoms

Inactive treatment with MoodHeadBand (Placebo) DEVICE

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.

(B) Patients diagnosed with moderate to severe depression without psychotic symptoms

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital: lead
• Innovation Fund Denmark: collaborator
• Danish Medical Association: collaborator
• Doctor Gerhard Linds scholarship: collaborator
• MoodHeadBand Aps: collaborator

Study Sites (1)

Psychiatric Center Copenhagen

Frederiksberg, Capital Region, 2600, Denmark

RECRUITING

Related Publications (1)

• Brandborg Sorensen N, Haahr U, Larsen MP, Hansen J, Nyholm S, Videbech P, Bohr T, Miskowiak KW, Martiny K, Jorgensen MB. Active versus sham transcranial pulsed electromagnetic field headband treatment for major depression: protocol for a double-blinded randomised trial. BMJ Open. 2025 Oct 20;15(10):e104474. doi: 10.1136/bmjopen-2025-104474.

  PMID: 41120157 DERIVED

MeSH Terms

Conditions

Depressive Disorder; Depression

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Martin B. Jørgensen, MD MSc

  Psychiatric Center Copenhagen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin B. Jørgensen, MD DMSc

CONTACT

23328669; Martin.Balslev.Joergensen@regionh.dk

Nana B Sørensen, MD

CONTACT

26356751; nana.brandborg.soerensen@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The patients and the research team don't know which headbands apply treatment A or B. The firm MoodHeadBand Aps was in charge of the randomization procedure, but will not know which patient receive treatment A or B. The headbands, control boxes and powerbanks are identifical. No difference can be seen or felt when the headbands are plugged into the control boxes and powerbanks. A small bulb will be lit when the controlbox is connected to a charged powerbank.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, dr. med.

Model Details: 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.

Study Record Dates

• First Submitted: August 15, 2023
• First Posted: August 22, 2023
• Study Start: June 17, 2024
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)