How brain functioning affects the results of transcranial magnetic stimulation treatment
| ISRCTN | ISRCTN18267156 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18267156 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 7111 |
| Sponsor | Hospital District of Helsinki and Uusimaa |
| Funders | Research Council of Finland, Helsinki and Uusimaa Hospital District, Government of Finland |
- Submission date
- 22/08/2025
- Registration date
- 28/08/2025
- Last edited
- 09/09/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
The symptoms of depression can be complex and vary widely between people. If you're depressed, you may feel sad, hopeless and lose interest in things you used to enjoy.
Transcranial magnetic stimulation (TMS) is a noninvasive procedure that uses magnetic fields to stimulate nerve cells in the brain to improve symptoms of depression. TMS is typically used when medication hasn't been effective.
This study aims to test whether a new TMS protocol, including individual imaging-based targeting, improves outcomes in depression.
Who can participate?
Patients aged 18 to 67 years referred to the Helsinki University Central Hospital for rTMS for major depressive disorder (MDD)
What does the study involve?
The study involves a 2-hour visit to Aalto University Advanced Magnetic Imaging Centre for magnetic resonance imaging (MRI). This is followed by a 1-2-hour meeting including definition of dose and possible targets for the treatment. A nurse uses a randomized list to select the protocol, and the participants and the researchers who evaluate the outcome will not know the method. TMS is delivered five times a week for up to 20 sessions and combined with brief cognitive tasks and questionnaires.
What are the possible benefits and risks of participating?
Possible benefits of the study include improved outcomes of rTMS treatment and risks resemble those of usual TMS treatment, including uncomfortable stimulation site sensations and a small risk of seizure.
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 2023 to May 2028
Who is funding the study?
1. Research Council of Finland
2. Finnish government funding for health care research
3. Helsinki and Uusimaa Hospital District
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
| Primary study design | Interventional |
|---|---|
| Study design | Interventional double-blind randomized controlled trial |
| Secondary study design | Randomised parallel trial |
| Study type | Participant information sheet |
| Scientific title | Effect of cognition and target model optimization on outcome of Helsinki individual transcranial magnetic stimulation treatment |
| Study acronym | HIT3 |
| Study objectives | New protocol results in better outcome than regular transcranial magnetic stimulation (TMS) |
| Ethics approval(s) |
Approved 25/06/2025, HUS regional medical research ethics committee (HUS Keskuskirjaamo, Helsinki, PO Box 200, Finland; +358 (0)403594618; eettiset.toimikunnat@hus.fi), ref: HUS/12135/2022 |
| Health condition(s) or problem(s) studied | Major depressive disorder, resistant to at least two antidepressants |
| Intervention | Participants are randomized 1:1 to receive transcranial magnetic theta burst stimulation with: 1. Regular theta burst protocol 2. New protocol including individually planned targeting Each group is further divided 1:1 to a cognitive priming task or no task. The research nurse who delivers treatment uses balanced lists for randomization, while researchers who evaluate the outcome and the patient remain blind to the treatment arm. Theta burst stimuli are delivered at 120% (or nearest tolerated) of motor threshold five times a week for 20 days. |
| Intervention type | Device |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Transcranial magnetic stimulation |
| Primary outcome measure(s) |
Severity of depression measured using the Montgomery Åsberg Depression Rating Scale (MADRS) rated before and within 2 weeks after treatment |
| Key secondary outcome measure(s) |
1. Functioning measured using the Social and Occupational Functioning Scale (SOFAS) before and within 2 weeks after treatment |
| Completion date | 31/05/2028 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 67 Years |
| Sex | All |
| Target sample size at registration | 80 |
| Key inclusion criteria | 1. Diagnosis of major depressive disorder (DSM-IV) as the principal diagnosis with Patient Health Questionnaire-9 score >14 2. Inability to tolerate antidepressant medication or unresponsiveness to minimum of 2 months trial with adequate dose of antidepressant 3. No change in antidepressive medication in 4 weeks prior to treatment |
| Key exclusion criteria | 1. Previous rTMS treatment 2. Borderline personality features exceeding 7 points in McLean Screening Instrument for Borderline Personality Disorder, or other somatic or psychiatric conditions that likely interfere with recovery from depression with TMS (an unstable medical illness, substantial neurological illness, chronic pain, psychotic disorder or current psychotic symptoms, substance abuse or dependency within last 3 months, >2 mg lorazepine equivalents benzodiazepine use daily or any anticonvulsant, or lifetime history of non-response to an adequate course - i.e., a minimum of eight treatments - of electroconvulsive therapy) 3. Patients with safety risks including active suicidality, pregnancy, magnetic metal or leads in the upper body, or history of seizures |
| Date of first enrolment | 15/09/2025 |
| Date of final enrolment | 31/12/2027 |
Locations
Countries of recruitment
- Finland
Study participating centre
PO Box 590
Helsinki
00029 HUS
Finland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
09/09/2025: Ethics approval details added.
22/08/2025: Study's existence confirmed by HUS regional medical research ethics committee.
