{
  "abstract": "Introduction A 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.",
  "authors": [
    {
      "affiliations": [
        "Copenhagen Affective Disorder Research Center (CADIC), Copenhagen Psychiatric Center, Frederiksberg Hospital, Copenhagen, Denmark",
        "Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark"
      ],
      "name": "Nana Brandborg Sørensen"
    },
    {
      "affiliations": [
        "Psychiatry Region Zealand, Region Zealand, Denmark"
      ],
      "name": "Ulrik Haahr"
    },
    {
      "affiliations": [
        "Copenhagen Affective Disorder Research Center (CADIC), Copenhagen Psychiatric Center, Frederiksberg Hospital, Copenhagen, Denmark"
      ],
      "name": "Malina Ploug Larsen"
    },
    {
      "affiliations": [
        "Psychotherapeutic Unit, CFF4, Copenhagen Psychiatric Center, Frederiksberg Hospital, Copenhagen, Denmark"
      ],
      "name": "Jørgen Hansen"
    },
    {
      "affiliations": [
        "Former Air Trafic Control Project Manager, Naviair, Copenhagen, Denmark"
      ],
      "name": "Svend Nyholm"
    },
    {
      "affiliations": [
        "Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark",
        "Center for Neuropsychiatric Depression Research, Copenhagen University Hospital – Mental Health Services CPH, Mental Health Center Glostrup, Glostrup, Denmark"
      ],
      "name": "Poul Videbech"
    },
    {
      "affiliations": [
        "Physics Department, Danish Technical University (DTU), Copenhagen, Denmark"
      ],
      "name": "Tomas Bohr"
    },
    {
      "affiliations": [
        "Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark",
        "Neurocognition and Emotion in Affective Disorders (NEAD) Centre, Psychiatric Center Copenhagen, Copenhagen, Denmark"
      ],
      "name": "Kamilla W Miskowiak"
    },
    {
      "affiliations": [
        "Copenhagen Affective Disorder Research Center (CADIC), Copenhagen Psychiatric Center, Frederiksberg Hospital, Copenhagen, Denmark",
        "Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark"
      ],
      "name": "Klaus Martiny"
    },
    {
      "affiliations": [
        "Copenhagen Affective Disorder Research Center (CADIC), Copenhagen Psychiatric Center, Frederiksberg Hospital, Copenhagen, Denmark",
        "Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark"
      ],
      "name": "Martin Balslev Jorgensen"
    }
  ],
  "title": "Active versus sham transcranial pulsed electromagnetic field headband treatment for major depression: protocol for a double-blinded randomised trial",
  "uid": "31c674ec-3925-5e74-81d9-392bb6a2df4e"
}