ArticleBMJ open2025
Active versus sham transcranial pulsed electromagnetic field headband treatment for major depression: protocol for a double-blinded randomised trial.
Article in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06005103 (Active Versus Sham Transcranial Pulsed Electromagnetic Field Headband Treatment for Major Depression), which is not on this map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Active Versus Sham Transcranial Pulsed Electromagnetic Field Headband Treatment for Major Depression: a Study Protocol for a Double-blinded Randomized Trial
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0 citing papers in PubMed.
No citing paper in PubMed yet.
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Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionA substantial number of patients with major depressive disorder experience non-remission despite treatment with psychotherapy and several antidepressant drugs. This has increased the interest in new treatment strategies, including non-invasive brain stimulation methods. This randomised controlled trial examines a new treatment method using transcranial-pulsed electromagnetic fields (T-PEMF) delivered via a MoodHeadBand (MHB). The main study objective is to examine the antidepressant effect of T-PEMF on moderate to severe depression. METHODS AND ANALYSIS: A double-blinded, randomised (1:1), sham-controlled trial with 96 participants diagnosed with moderate to severe depression without psychotic symptoms, recruited from Psychiatric Center Copenhagen. Participants receive daily 30 min at-home T-PEMF or sham treatment for 8 weeks with the MHB. Depressive symptomatology is examined using the Inventory of Depressive Symptomatology (Self-Report) (primary outcome) and Hamilton-D-17 Items Rating Scale at baseline and treatment completion. Cognitive functions are examined using a battery of emotion-laden and non-emotion-laden tests at baseline, after 1 week and at treatment completion. The participants fill out the Quick Inventory of Depressive Symptomatology (Self-Report) and sleep logs weekly. Summary statistics, generalised linear models, proc mixed models, mixed model repeated measures and Kaplan-Meier analysis will be applied as appropriate to analyse data on depressive symptoms, cognition and sleep. ETHICS AND DISSEMINATION: The Danish Medicines Agency (CIV-23-01-041987) and the Medical Research Ethics Committee (2215332) have approved the trial. The project concurs with the EU directive for medical devices 2017/745 of 5 April 2017 and the ISO 14155 standard. Participants give written informed consent before any trial-related activities. Results will be published in peer-reviewed journals and presented at relevant conferences. TRIAL REGISTRATION NUMBER: NCT06005103.
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