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

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Transcranial Pulsed Electromagnetic Fields (T-PEMF) delivered via a headband
No treatment delivered via headband
Sponsored by
Mental Health Services in the Capital Region, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Moderate Depression focused on measuring Randomized Controlled Trial, Depression, Transcranial Pulsed Electro-Magnetic Fields (T-PEMF), Psychiatry

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Psychiatric Center CopenhagenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active treatment with T-PEMF (Active)

Inactive treatment with T-PEMF (sham)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Hamilton-D17 (HAM-D17)
A scale measuring depressive symptoms. Will be applied at baseline and at the end point
Hamilton-D6 (HAM-D6)
A scale measuring depressive symptoms. Will be applied at baseline and at the end point.
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).
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.

Full Information

First Posted
August 15, 2023
Last Updated
August 15, 2023
Sponsor
Mental Health Services in the Capital Region, Denmark
Collaborators
Innovation Fund Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT06005103
Brief Title
T-PEMF Headband Stimulation for Patients With Moderate to Servere Depression
Official Title
An 8-week Randomized Trial Comparing Treatment With an Active or Sham T-PEMF Headband Stimulation for Patients With Moderate to Servere Depression
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 6, 2023 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mental Health Services in the Capital Region, Denmark
Collaborators
Innovation Fund Denmark

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Neither patients nor the research team knows which headbands apply treatment A or B. The firm MoodHeadBand Aps was in charge of the randomization procedure. 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.
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active treatment with T-PEMF (Active)
Arm Type
Experimental
Arm Description
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.
Arm Title
Inactive treatment with T-PEMF (sham)
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Transcranial Pulsed Electromagnetic Fields (T-PEMF) delivered via a headband
Other Intervention Name(s)
T-PEMF delivered via MoodHeadBand (MHB)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
No treatment delivered via headband
Other Intervention Name(s)
No treatment delivered via MoodHeadBand (MHB)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Inventory of Depressive Symptomatology (Self-Report) (IDS-SR)
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Hamilton-D17 (HAM-D17)
Description
A scale measuring depressive symptoms. Will be applied at baseline and at the end point
Time Frame
8 weeks
Title
Hamilton-D6 (HAM-D6)
Description
A scale measuring depressive symptoms. Will be applied at baseline and at the end point.
Time Frame
8 weeks
Title
WHO-5
Description
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).
Time Frame
8 weeks
Title
Udvalget for Kliniske Undersøgelser scale (UKU-24)
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Martin B. Jørgensen, MD DMSc
Phone
23328669
Ext
+45
Email
Martin.Balslev.Joergensen@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Ulrik H. Haahr, MD
Phone
53765787
Ext
+45
Email
ulrik.helt.haahr@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin B. Jørgensen, MD MSc
Organizational Affiliation
Psychiatric Center Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Psychiatric Center Copenhagen
City
Frederiksberg
State/Province
Capital Region
ZIP/Postal Code
2600
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nana B. Sørensen, MD
Phone
23 26 70 81
Ext
+45
Email
nana.brandborg.soerensen@regionh.dk
First Name & Middle Initial & Last Name & Degree
Nana Brandborg B. Sørensen, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
It is not possible to share individual participant data due to GDPR. Anonymised data after publishing might be available per request.

Learn more about this trial

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

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