Helsinki improved transcranial magnetic stimulation for depression
| ISRCTN | ISRCTN46722730 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN46722730 |
| Secondary identifying numbers | HUS/1232/2021 |
- Submission date
- 26/05/2021
- Registration date
- 01/06/2021
- Last edited
- 14/02/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- 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 other depression treatments haven't been effective.
The present randomized study aims to test whether a new targeting method of repetitive transcranial magnetic stimulation (rTMS) improves outcomes in depression and to develop imaging-based targeting of TMS further.
Who can participate?
Patients referred to the Helsinki University Central Hospital for rTMS for major depressive disorder (MDD) are asked to participate.
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 2-hour meeting with a psychiatrist including an interview and definition of dose and possible targets for the treatment. A nurse delivering the treatment uses a randomized list to select the targeting method, and participants and researchers who evaluate the outcome are blind to the method. TMS is delivered 5 times a week for up to 20 sessions or remission and continued 5 more times in case of partial response.
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) in collaboration with researchers at the Aalto University and Massachusetts General Hospital (USA)
When is the study starting and how long is it expected to run for?
May 2021 to February 2025
Who is funding the study?
Finnish government funding for the health care research and the Helsinki and Uusimaa Hospital District.
Who is the main contact?
Dr Tuukka Raij, tuukka.raij@hus.fi
Contact information
Scientific
Hospital District of Helsinki and Uusimaa
Valskarinkatu 12
Helsinki
POBox 590 00290 HUS
Finland
 ORCID ID |
0000-0002-9834-5570 |
|---|---|
| Phone | +358 504285473 |
| tuukka.raij@hus.fi |
Study information
| Study design | Interventional double-blind randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | Helsinki Improved Transcranial magnetic stimulation vs treatment as usual for depression |
| Study acronym | HIT |
| Study objectives | Helsinki Improved Transcranial magnetic stimulation reduces depression symptoms more than usual Transcranial magnetic stimulation |
| Ethics approval(s) | Approved 19/05/2021, HUS Ethics committee IV (PL 705, 00029 HUS Biomedicum Helsinki 2 C 7.krs, Tukholmankatu 8 C, Helsinki, Finland; +358403594618; eettiset.toimikunnat@hus.fi), ref: HUS/1232/2021 |
| Health condition(s) or problem(s) studied | Major depressive disorder |
| Intervention | Participants are randomized 1:1 to receive transcranial magnetic theta burst stimulation with 1. Regular targeting method based on skull metrics, or 2. Individually planned targeting based on functional imaging 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 110 - 120% (or nearest tolerated) of motor threshold five times a week for maximum of 25 days. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Transcranial magnetic stimulation |
| Primary outcome measure | Current primary outcome measure as of 03/06/2021: Montgomery Åsberg Depression Rating Scale (MADRS) rated by research team psychiatrist before, and within two weeks after treatment _____ Previous primary outcome measure: Montgomery Åsberg Depression Rating Scale (MADRS) rated by research team psychiatrist before, and within one week after treatment |
| Secondary outcome measures | Current secondary outcome measures as of 03/06/2021: 1. Social and occupational functioning scale (SOFAS) rated by research team psychiatrist before and within 2 weeks after treatment 2. Self-evaluated Patient health questionnaire (PHQ-9) measured before and within 2 weeks after treatment and 6 weeks after treatment 3. Remission defined as MADRS <11 within 2 weeks after treatment (rated by research team psychiatrist) 4. Response defined as MADRS within 2 weeks after treatment >50 % less than MADRS before treatment (rated by research team psychiatrist) _____ Previous secondary outcome measures: 1. Social and occupational functioning scale (SOFAS) rated by research team psychiatrist before and within one week after treatment 2. Self-evaluated Patient health questionnaire (PHQ-9) measured before and within one week after treatment and six weeks after treatment 3. Remission defined as MADRS <11 within one week after treatment (rated by research team psychiatrist) 4. Response defined as MADRS within one week after treatment >50 % less than MADRS before treatment (rated by research team psychiatrist) |
| Overall study start date | 19/05/2021 |
| Completion date | 28/02/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Independent data monitoring group conducts interim analysis at n = 40 with stopping rules p < 0.005 or a new power calculation suggesting power < 80 % to detect group difference with p < 0.048 with n = 80 |
| Total final enrolment | 94 |
| 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 four 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—ie, 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 | 14/06/2021 |
| Date of final enrolment | 31/12/2024 |
Locations
Countries of recruitment
- Finland
Study participating centre
Valskarinkatu 12
Helsinki
PL590, 00029 HUS
Finland
Sponsor information
Hospital/treatment centre
Valskarinkatu 12
Helsinki
PL590, 00290 HUS
Finland
| Phone | +358 50 4631142 |
|---|---|
| piia.frondelius@hus.fi | |
"ROR" |
https://ror.org/020cpqb94 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 31/05/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Findings are published in congress abstracts and peer reviewed Journals. |
| 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. Psychiatric patients are unfortunately still sometimes discriminated and publishing detailed individual data collected in the present study would possess a risk of identification. |
Editorial Notes
14/02/2025: The following changes were made to the study record:
1. The recruitment end date was changed from 28/02/2025 to 31/12/2024.
2. The overall study end date was changed from 31/05/2025 to 28/02/2025.
3. Total final enrolment added.
27/12/2023: The following changes have been made:
1. The recruitment end date has been changed from 28/02/2024 to 28/02/2025.
2. The overall study end date has been changed from 31/05/2024 to 31/05/2025 and the plain English summary updated accordingly.
3. The intention to publish date has been changed from 31/12/2024 to 31/05/2026.
04/10/2022: The intention to publish date was changed from 31/12/2023 to 31/12/2024.
28/09/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/12/2022 to 28/02/2024.
2. The overall trial end date was changed from 31/12/2022 to 31/05/2024.
03/06/2021: The following changes were made to the trial record:
1. The primary outcome measure was changed.
2. The secondary outcome measures were changed.
28/05/2021: Trial's existence confirmed by HUS Ethics committee IV.
