A Randomized Clinical Trial Comparing Active Versus Sham T-PEMF Headband Treatment for Depression
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Treatment with MoodHeadBand (T-PEMF treatment), Inactive treatment with MoodHeadBand (Placebo).
- Who it may be relevant to
- Registry conditions: Moderate Depression, Severe Depressive Episode Without Psychotic Symptoms, Recurrent Depressive Disorder, Current Episode Moderate, Recurrent Depressive Disorder, Current Episode Severe Without Psychotic Symptoms. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Active Versus Sham Transcranial Pulsed Electromagnetic Field Headband Treatment for Major Depression: a Study Protocol for a Double-blinded Randomized Trial
Overview
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
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.
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.
Primary outcome measures
- Inventory of Depressive Symptomatology (Self-Report) (IDS-SR) [Time frame: 8 weeks]
Secondary outcome measures (10)
- Hamilton-D17 (HAM-D17) [Time frame: 8 weeks]
- Hamilton-D6 (HAM-D6) [Time frame: 8 weeks]
- Quick Inventory of Depressive Symptomatology [Time frame: 8 weeks]
- WHO-5 [Time frame: 8 weeks]
- Facial Expression and Recognition Test (FERT) [Time frame: 8 weeks]
- Emotional Categorization and Memory Test (ECMT) [Time frame: 8 weeks]
- Screening of cognitive impairment in Psychiatry (SCIP) [Time frame: 8 weeks]
- Trail Making Test B (TMT-B) [Time frame: 8 weeks]
- Sleep diary [Time frame: 8 weeks]
- Udvalget for Kliniske Undersøgelser scale (UKU-24) [Time frame: 8 weeks]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Denmark · 1 center
- Psychiatric Center Copenhagen — Frederiksberg
Publications
- 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
Identifiers
NCT: NCT06005103 · 2215332