How to tell who will benefit from magnetic stimulation for depression
| ISRCTN | ISRCTN30067246 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN30067246 |
| Secondary identifying numbers | 9137 |
- Submission date
- 16/09/2025
- Registration date
- 18/09/2025
- Last edited
- 17/09/2025
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Depression symptoms can be complex and vary greatly from person to person. If you’re depressed, you may feel sad, hopeless, and lose interest in activities you once enjoyed. Transcranial magnetic stimulation (TMS) is a noninvasive procedure that uses magnetic fields to stimulate nerve cells in the brain, helping to improve depression symptoms. TMS is typically recommended when medications have not been effective. This study aims to determine whether combining brain imaging data with clinical information can predict who will benefit most from TMS treatment. A secondary goal is to investigate whether the orientation of the magnetic coil affects the treatment’s effectiveness.
Who can participate?
Patients aged 18 to 67 years referred to the Helsinki University Central Hospital for TMS for major depressive disorder (MDD).
What does the study involve?
The study includes several steps:
-A clinical interview conducted by phone or face-to-face (about 30 minutes).
-Completing digital questionnaires up to five times during the study to monitor symptoms, personality, anxiety, and functioning.
-Providing a blood sample for genetic and biological analysis, or a saliva sample that you can collect at home and mail.
-Brain imaging using Magnetoencephalography (MEG) and Magnetic Resonance Imaging (MRI), both before and after treatment. MEG measures brain activity via magnetic fields, and MRI provides detailed anatomical images. Each imaging session takes about 1 to 2 hours.
-Receiving transcranial direct current stimulation (tDCS) treatment before TMS, if you choose to.
-36 sessions of TMS treatment.
What are the possible benefits and risks of participating?
Possible benefits of the study include better outcomes from TMS treatment, as participants receive more sessions than typically offered in Finnish public health care (36 instead of 20). The risks are similar to those of standard TMS treatment and may include uncomfortable sensations at the stimulation site.
Where is the study run from?
Helsinki University Central Hospital Department of Psychiatry (Finland)
When is the study starting and how long is it expected to run for?
January 2025 to December 2028
Who is funding the study?
Business Finland
Who is the main contact?
Dr Tuukka Raij, tuukka.raij@hus.fi
Contact information
Public, Scientific, Principal Investigator
Valskarinkatu 12
PO Box 590
Helsinki
00290 HUS
Finland
 ORCID ID |
0000-0002-9834-5570 |
|---|---|
| Phone | +358 (0)504285473 |
| tuukka.raij@hus.fi |
Study information
| Study design | Longitudinal predictor study including an Interventional double-blind randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home, Hospital, Internet/virtual, Laboratory, Telephone |
| Study type | Treatment |
| Scientific title | Models of treatment response prediction in depression based on brain structure and function |
| Study objectives | A model combining clinical and brain data can predict who will benefit from TMS treatment. Positioning the coil perpendicular to the main local gyrus in the dorsolateral prefrontal cortex leads to better outcomes. |
| Ethics approval(s) |
Approved 08/07/2025, HUS regional medical research ethics committee (HUS Keskuskirjaamo, Helsinki, PO Box 200, Finland; +358 (0)403594618; eettiset.toimikunnat@hus.fi), ref: HUS/6633/2025 |
| Health condition(s) or problem(s) studied | Major depressive disorder |
| Intervention | Participants enrolled in this study will be involved for a total duration of approximately 24 to 36 weeks, depending on whether they receive both the transcranial direct current stimulation (tDCS) and repetitive transcranial magnetic stimulation (rTMS) interventions. Enrollment and Consent: Participants provide electronic informed consent via the REDCap system, a secure, web-based tool for data collection. Baseline Assessments: A clinical interview is conducted by a trained nurse or psychologist via telephone or face-to-face to confirm eligibility and assess depression symptoms using the MINI International Neuropsychiatric Interview (MINI 6.0, Finnish version) and Montgomery–Åsberg Depression Rating Scale (MADRS). Participants complete baseline digital symptom questionnaires assessing depression, anxiety, personality, and other relevant factors. Biological Sampling: Participants provide either a blood sample at HUSLAB Tullinpuomi laboratory or a saliva sample collected at home via a mailed kit for genetic and biological analyses. Brain Imaging: Magnetoencephalography (MEG) and magnetic resonance imaging (MRI) scans are performed twice—once before any intervention and once after—to assess brain function and structure. Randomisation: Participants who have consented to receive tDCS undergo 12 weeks of home-based tDCS treatment. Those who do not remit after tDCS, as well as participants who opt out of tDCS, are randomized in a 1:1 ratio to receive rTMS with two different orientations of the magnetic field (orthogonal or parallel to cortical gyri). Randomisation is performed using block randomisation via a computer program to minimize bias from temporal recruitment variations. Treatments: tDCS: Participants self-administer daily (up to 5 days/week for the first 6 weeks, then 3 days/week for the following 6 weeks) 30-minute tDCS sessions at home using a CE-marked Sooma device delivering 2 mA direct current over the dorsolateral prefrontal cortex (DLPFC). Treatment adherence and guidance are supported via a mobile application. rTMS: Administered by a trained nurse at the HUS neuromodulation unit 3–5 times per week over 12 weeks (total 36 sessions). Treatment involves 3.5-minute intermittent theta burst stimulation (iTBS) targeting the left DLPFC. Follow-Up and Assessments: Symptom questionnaires are completed digitally up to five times throughout the study: at baseline and end-points of each intervention phase, and at 12 weeks post-rTMS to monitor treatment effects and symptom changes. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Transcranial magnetic stimulation |
| Primary outcome measure | Severity of depression measured using the self-evaluated Patient health questionnaire (PHQ-9) before and within 2 weeks after treatment |
| Secondary outcome measures | 1. Remission defined as PHQ-9 < 5 within 2 weeks after treatment 2. Response defined as PHQ-9 within 2 weeks after treatment >50 % less than MADRS before treatment 3. Severity of depression measured using the Montgomery Åsberg Depression Rating Scale (MADRS) rated before and within 2 weeks after treatment |
| Overall study start date | 01/01/2025 |
| Completion date | 31/12/2028 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 67 Years |
| Sex | Both |
| Target number of participants | 100 |
| Key inclusion criteria | 1. Age 18–67 years 2. PHQ-9 score > 10 before treatment 3. Signed informed consent |
| Key exclusion criteria | 1. Safety risks, such as a concrete and imminent suicide plan, pregnancy or breastfeeding, magnetic metal parts in the upper body, or a significant risk of seizures. 2. Severe neurological conditions such as epilepsy or brain injury, as well as psychotic disorders 3. Impaired decision-making capacity 4. Those serving a prison sentence and those involved in forensic psychiatric proceedings |
| Date of first enrolment | 06/10/2025 |
| Date of final enrolment | 31/12/2027 |
Locations
Countries of recruitment
- Finland
Study participating centre
PO Box 590
Helsinki
00029 HUS
Finland
Sponsor information
Hospital/treatment centre
Välskärinkatu 12
PO Box 590
Helsinki
00029 HUS
Finland
| Phone | +358 (0)406127001 |
|---|---|
| pia.virtanen@hus.fi | |
| Website | https://www.helsinki.fi/fi/laaketieteellinen-tiedekunta/tutkimus/tieteenalat/psykiatrian-osasto |
"ROR" |
https://ror.org/020cpqb94 |
Funders
Funder type
Government
Government organisation / Local government
- Location
- Finland
Results and Publications
| Intention to publish date | 10/12/2028 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to the need to protect privacy of the participants. |
Editorial Notes
16/09/2025: Study's existence confirmed by the Hospital District of Helsinki and Uusimaa (HUS) Regional Medical Research Ethics Committee, Finland.
