Moderate DepressionNCT06005103
A Randomized Clinical Trial Comparing Active Versus Sham T-PEMF Headband Treatment for Depression
A study testing Treatment with MoodHeadBand (T-PEMF treatment) in people with Moderate Depression and Severe Depressive Episode Without Psychotic Symptoms, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 1 site in Denmark.
Trial 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 depression using using a new device, the MoodHeadBand (MHB). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Moderate Depression, Severe Depressive Episode Without Psychotic Symptoms, Recurrent Depressive Disorder, Current Episode Moderate
- What is being tested?
- Treatment with MoodHeadBand (T-PEMF treatment)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 117 participants
- Where
- 1 siteDenmark
- Study dates
- 17 Jun 2024to 30 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- Other diagnoses of organic brain disease.
- The participant has any kind of implant, e.g. pacemakers or cochlear implants.
- Female participants: Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Psychiatric Center Copenhagen
Frederiksberg, Capital Region, 2600
Nana B. Sørensen, MD, 23 26 70 81 ext. +45, nana.brandborg.soerensen@regionh.dk
Nana Brandborg B. Sørensen, MD
About this study
Official title: Active Versus Sham Transcranial Pulsed Electromagnetic Field Headband Treatment for Major Depression: a Study Protocol for a Double-blinded Randomized Trial
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 depression using using a new device, the MoodHeadBand (MHB).
The participants will use an active or placebo MHB for 30 minutes daily for 8 weeks.
Read more
Additionally, the following research questions will be answered:
- 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.
- If the T-PEMF treatment provides improvement in restorative sleep after 8 weeks of treatment
Read the 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 electromagnetic 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.
- Conditions
- Moderate Depression, Severe Depressive Episode Without Psychotic Symptoms, Recurrent Depressive Disorder, Current Episode Moderate, Recurrent Depressive Disorder, Current Episode Severe Without Psychotic Symptoms
- Being tested
- Treatment with MoodHeadBand (T-PEMF treatment), Inactive treatment with MoodHeadBand (Placebo)
- Keywords
- Randomized Controlled Trial, Depression, Transcranial Pulsed Electro-Magnetic Fields (T-PEMF), Psychiatry, Cognition, Sleep
- Medical subject headings
- Depressive Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment with MoodHeadBand (T-PEMF treatment)Device
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.
Inactive treatment with MoodHeadBand (Placebo)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| (A) Patients diagnosed with moderate to severe depression without psychotic symptoms | Experimental | In total, 48 patients will be allocated to this arm.
(In total, 117 patients will be included in the study. Data for the initial 21 patients included in the study could not be used to assess the antidepressant effect, why an increased number of participants was needed to secure the power for the trial. The technical difficulties have been addressed) Receives: Device: Treatment with MoodHeadBand (T-PEMF treatment) |
| (B) Patients diagnosed with moderate to severe depression without psychotic symptoms | Sham comparator | In total, 48 patients will be allocated to this arm.
(In total, 117 patients will be included in the study. Data for the initial 21 patients included in the study could not be used to assess the antidepressant effect, why an increased number of participants was needed to secure the power for the trial. The technical difficulties have been addressed) Receives: Device: Inactive treatment with MoodHeadBand (Placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 8 weeks
Secondary outcomes (10)
Hamilton-D17 (HAM-D17)
A scale measuring depressive symptoms. Will be applied at baseline and at the end point
Measured: 8 weeks
Hamilton-D6 (HAM-D6)
A scale measuring depressive symptoms. Will be applied at baseline and at the end point.
Measured: 8 weeks
Quick Inventory of Depressive Symptomatology
A quick-version of the IDS questionnaire, that consists of 16 questions. Patients fill this assesment on a weekly basis during the study.
Measured: 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).
Measured: 8 weeks
Facial Expression and Recognition Test (FERT)
A test that assesses the patients recognition of - and attention to facial expressions as a part of the cognitive test battery that explores the patients "hot" cognition.
Measured: 8 weeks
Emotional Categorization and Memory Test (ECMT)
A test that assesses the patient' self-referential memory with emotion laded words as a part of the cognitive test battery that explores the patients' "hot" cognition.
Measured: 8 weeks
Screening of cognitive impairment in Psychiatry (SCIP)
A screening tool used to assess cognitive performance in psychiatric patients. The test includes List learning, delayed list learning, verbal fluency, visuomotor tracking tests. Explores the patients' "cold" cognitive mechanisms.
Measured: 8 weeks
Trail Making Test B (TMT-B)
A test that assesses the patients' visual attention and ability to switch tasks. Explores the patients' "cold" cognitive mechanisms.
Measured: 8 weeks
Sleep diary
The diary explores the patients sleep pattern and quality of sleep.
Measured: 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start17 Jun 2024
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Moderate DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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. An independent person tests the devices to ensure the devices function properly and to ensure that each bag contain an equal amount of active and placebo devices.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 117 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Innovation Fund Denmark, Danish Medical Association, Doctor Gerhard Linds scholarship, MoodHeadBand Aps
- Responsible party
- Principal investigator, Martin Balslev Jørgensen, Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Investigators
- Martin B. Jørgensen, MD MSc, Principal investigator, Psychiatric Center Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06005103
- Sponsor's protocol ID
- 2215332
- Status last verified
- Aug 2025
- First submitted
- 15 Aug 2023
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is not possible to share individual participant data due to GDPR. Anonymised data after publishing might be available per request.
Publications
Brandborg Sorensen N, Haahr U, Larsen MP, Hansen J, Nyholm S, Videbech P, Bohr T, Miskowiak KW, Martiny K, Jorgensen MB. Active versus sham transcranial pulsed electromagnetic field headband treatment for major depression: protocol for a double-blinded randomised trial. BMJ Open. 2025 Oct 20;15(10):e104474. doi: 10.1136/bmjopen-2025-104474.
PubMed 41120157
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Versus Sham Transcranial Pulsed Electromagnetic Field Headband Treatment for Major Depression: a Study Protocol for a Double-blinded Randomized Trial
- ClinicalTrials.gov ID
- NCT06005103
- Acronym / sponsor ID
- 2215332
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 117 participants (estimated)
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg HospitalUniversity, hospital or other
- Collaborators
- Innovation Fund Denmark, Danish Medical Association, Doctor Gerhard Linds scholarship, MoodHeadBand Aps
- Study start
- 17 Jun 2024 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 22 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 depression using 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:
- 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.
- 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 electromagnetic 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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. An independent person tests the devices to ensure the devices function properly and to ensure that each bag contain an equal amount of active and placebo devices.
| Arm | Type | Receives |
|---|---|---|
| (A) Patients diagnosed with moderate to severe depression without psychotic symptoms | Experimental | Device: Treatment with MoodHeadBand (T-PEMF treatment)In total, 48 patients will be allocated to this arm. (In total, 117 patients will be included in the study. Data for the initial 21 patients included in the study could not be used to assess the antidepressant effect, why an increased number of participants was needed to secure the power for the trial. The technical difficulties have been addressed) |
| (B) Patients diagnosed with moderate to severe depression without psychotic symptoms | Sham comparator | Device: Inactive treatment with MoodHeadBand (Placebo)In total, 48 patients will be allocated to this arm. (In total, 117 patients will be included in the study. Data for the initial 21 patients included in the study could not be used to assess the antidepressant effect, why an increased number of participants was needed to secure the power for the trial. The technical difficulties have been addressed) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment with MoodHeadBand (T-PEMF treatment)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 | (A) Patients diagnosed with moderate to severe depression without psychotic symptoms |
| Inactive treatment with MoodHeadBand (Placebo)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 | (B) Patients diagnosed with moderate to severe depression without psychotic symptoms |
Primary outcome
Inventory of Depressive Symptomatology (Self-Report) (IDS-SR)
Time frame: 8 weeks
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).
10 secondary outcomes
Hamilton-D17 (HAM-D17)
Time frame: 8 weeks
Hamilton-D6 (HAM-D6)
Time frame: 8 weeks
Quick Inventory of Depressive Symptomatology
Time frame: 8 weeks
WHO-5
Time frame: 8 weeks
Facial Expression and Recognition Test (FERT)
Time frame: 8 weeks
Emotional Categorization and Memory Test (ECMT)
Time frame: 8 weeks
Screening of cognitive impairment in Psychiatry (SCIP)
Time frame: 8 weeks
Trail Making Test B (TMT-B)
Time frame: 8 weeks
Sleep diary
Time frame: 8 weeks
Udvalget for Kliniske Undersøgelser scale (UKU-24)
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Derived from this study: PubMed 41120157Brandborg Sorensen N, Haahr U, Larsen MP, Hansen J, Nyholm S, Videbech P, Bohr T, Miskowiak KW, Martiny K, Jorgensen MB. Active versus sham transcranial pulsed electromagnetic field headband treatment for major depression: protocol for a double-blinded randomised trial. BMJ Open. 2025 Oct 20;15(10):e104474. doi: 10.1136/bmjopen-2025-104474.
- Individual participant dataSharing planned: No. It is not possible to share individual participant data due to GDPR. Anonymised data after publishing might be available per request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Martin B. Jørgensen, MD MSc principal investigator
Psychiatric Center Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment with MoodHeadBand (T-PEMF treatment) in people with Moderate Depression and Severe Depressive Episode Without Psychotic Symptoms, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martin B. Jørgensen, MD DMSc (23328669 ext. +45, Martin.Balslev.Joergensen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inventory of Depressive Symptomatology (Self-Report) (IDS-SR) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06005103, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2025.