Clinical trial NCT06005103: T-PEMF Headband Stimulation for Patients With Moderate to Servere Depression
Official title: A Randomized Clinical Trial Comparing Active Versus Sham T-PEMF Headband Treatment for Depression
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: 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
Cognition
Sleep
Lead sponsor: Mental Health Services in the Capital Region, Denmark
Sponsor class: OTHER
Collaborators: name: Innovation Fund Denmark
name: Danish Medical Association
name: Doctor Gerhard Linds scholarship
name: MoodHeadBand Aps
First posted: 2023-08-22
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will receive either active (A) or placebo (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. There will be two bags to choose from, one bag is designated for patients who use antidepressant drugs, the other is designated for patients who do not use antidepressant drugs at the time of inclusion in the study. 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.
Primary purpose: TREATMENT

Brief summary: 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 depressionusing 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 the time to respond to treatment differ between the active treatment and sham group
2. 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.
3. 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 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.

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

Primary outcomes:
measure: Inventory of Depressive Symptomatology (Self-Report) (IDS-SR)
timeFrame: 8 weeks
Secondary outcomes:
measure: Hamilton-D17 (HAM-D17)
timeFrame: 8 weeks
measure: Hamilton-D6 (HAM-D6)
timeFrame: 8 weeks
measure: WHO-5
timeFrame: 8 weeks
measure: Facial Expression and Recognition Test (FERT)
timeFrame: 8 weeks
measure: Emotional Categorization and Memory Test (ECMT)
timeFrame: 8 weeks
measure: Screening of cognitive impairment in Psychiatry (SCIP)
timeFrame: 8 weeks
measure: Trail Making Test B (TMT-B)
timeFrame: 8 weeks
measure: Sleep diary
timeFrame: 8 weeks
measure: Udvalget for Kliniske Undersøgelser scale (UKU-24)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Frederiksberg
country: Denmark
facility: Psychiatric Center Copenhagen
state: Capital Region
Study officials:
affiliation: Psychiatric Center Copenhagen
name: Martin B. Jørgensen, MD MSc
role: PRINCIPAL_INVESTIGATOR
References: