T-PEMF Headband Stimulation for Patients With Moderate to Servere Depression

Study Overview
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Brief Summary
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This study is a blinded 8-week, randomized trial conducted to clarify whether treatment with brain stimulation for half an hour daily for eight weeks with a headband with weak pulsating electromagnetic fields (T-PEMF) can achieve a safe effect on depression compared to the same treatment with a placebo T-PEMF.

Detailed Description
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The study will take place at Psychiatric Center Copenhagen. 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. Previous Danish studies have shown a significant effect in the treatment of patients with treatment-resistant depression. There are no studies, neither in Denmark nor in the world, which demonstrate an effect on the early stages in the development of depressive disorders. The study is designed as a blinded, randomized study where active treatment is compared with inactive (sham) treatment. At the same time, possible side effects in the use of the headband (MoodHeadBand, MHB) are investigated. The project starts in May 2023. The aim is for 80 patients to be included in the study. 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 sham 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 the form of Cognitive Behavioral Therapy (CBT) in a group or individually and antidepressive medications. At the start, the clinical diagnosis is obtained and validated with a structured interview, to ensure that the diagnostic criteria for the diagnosis are present and that the exclusion criteria are not present. The degree of depression is examined with Hamilton's Depression Scale (HAM-D17), and Inventory of Depressive Symptomatology (IDS-SR). Quality of life (WHO-5) and degree of side effects (UKU-24) are included. Changes in the level of depression and side effects are measured by the Quick Inventory of Depressive Symptomatology (QIDS16-SR) every week after the start of treatment The degree of any side effects is measured at baseline and weeks 1, 2, 4, 6, and 8 by UKU-24. At the end of the treatment, the degree of depression is examined again using the HAM-D17, IDS-SR, and quality of life (WHO-5). The degree of satisfaction with the use of MHB is examined on a scale from 1-7. No significant side effects have been registered when using the same type of magnetic 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.

Official Title
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An 8-week Randomized Trial Comparing Treatment With an Active or Sham T-PEMF Headband Stimulation for Patients With Moderate to Servere Depression

Conditions
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Moderate Depression, Severe Depressive Episode Without Psychotic Symptoms, Recurrent Depressive Disorder, Current Episode Moderate, Recurrent Depressive Disorder, Current Episode Severe Without Psychotic Symptoms

Intervention / Treatment
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* Device: Transcranial Pulsed Electromagnetic Fields (T-PEMF) delivered via a headband
* Device: No treatment delivered via headband


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients will receive either active (A) or sham (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. 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.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active treatment with T-PEMF (Active)<br>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: Transcranial Pulsed Electromagnetic Fields (T-PEMF) delivered via a headband<br>* The headband will deliver a 55 Hz electromagnetic field, when plugged into a charged powerbank, if the device is programmed to deliver an active treatment.<br>* Other names: T-PEMF delivered via MoodHeadBand (MHB);|
| Sham Comparator: Inactive treatment with T-PEMF (sham)<br>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. | Device: No treatment delivered via headband<br>* The headband will be inactive and not deliver an electromagnetic field when plugged into a charged powerbank. The bulb on the control box will still be lit, when plugged to a powerbank.<br>* Other names: No treatment delivered via MoodHeadBand (MHB);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). IDS will be conducted assisted by a clinician at baseline and at the endpoint. Patients will receive a Quick-IDS via email on a weekly basis for self-report. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton-D17 (HAM-D17) | A scale measuring depressive symptoms. Will be applied at baseline and at the end point | 8 weeks | 
| Hamilton-D6 (HAM-D6) | A scale measuring depressive symptoms. Will be applied at baseline and at the end point. | 8 weeks | 
| WHO-5 | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Randomized Controlled Trial, Depression, Transcranial Pulsed Electro-Magnetic Fields (T-PEMF), Psychiatry