Functional imaging-based targeting of transcranial magnetic stimulation for treatment-resistant depression
| ISRCTN | ISRCTN11790528 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11790528 |
| Secondary identifying numbers | HUS/12135/2022 |
- Submission date
- 14/07/2023
- Registration date
- 14/08/2023
- Last edited
- 22/01/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
The symptoms of depression can vary, but the cardinal features are persistent low mood and/or inability to feel pleasure. 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.
Who can participate?
Patients whose doctors have referred them 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 targets for the treatment. A nurse delivers the treatment to each side of the forehead. S/he or the patient does not know whether the targeting is based on individual brain imaging or on average measures. Treatment visits take about 30 min 3-5 times a week up to 25 visits.
What are the possible benefits and risks of participating?
Possible benefits of the study include improved outcomes of rTMS treatment. Risks include uncomfortable stimulation site sensations and mild tiredness after treatment.
Where is the study run from?
HYKS Psykiatriakeskus, Helsinki (Finland)
When is the study starting and how long is it expected to run for?
September 2022 to May 2026
Who is funding the study?
1. Academy of Finland (Research Council of Finland), Helsinki and Uusimaa Hospital District (Finland)
2. Finnish Cultural Foundation (Suomen Kulttuurirahasto) (Finland)
3. Jalmari and Rauha Ahokas Foundation (Jalmari ja Rauha Ahokkaan Säätiö) (Finland)
Who is the main contact?
Dr Tuukka Raij, tuukka.raij@hus.fi
Contact information
Principal Investigator
HYKS Psykiatriakeskus, PL590
Helsinki
00029 HUS
Finland
 ORCID ID |
0000-0002-9834-5570 |
|---|---|
| Phone | +358504285473 |
| 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) | Hospital |
| Study type | Efficacy |
| Participant information sheet | 43951_PIS_V3_19May23.pdf |
| Scientific title | Comparison of Helsinki individual targeting and regular targeting in TMS treatment of depression |
| Study acronym | HIT2 |
| Study hypothesis | Functional imaging-based targeting results in better outcome than regular scalp measure-based targeting |
| Ethics approval(s) |
Approved 31/05/2023, HUS regional medical research ethics committee (HUS Keskuskirjaamo, Helsinki, PO Box 200, Finland; +358403594618; eettiset.toimikunnat@hus.fi), ref: HUS/12135/2022 |
| Condition | Major depressive disorder, resistant to at least two antidepressants |
| Intervention | Current interventions as of 22/01/2025: Targeting is alternated every 5th treatment session between: 1. Targeting based on group average of functional imaging 2. Targeting based on individual functional imaging The order of the targeting is randomized 1:1 according to a list for randomization. The patient and the research nurse who delivers treatment are blind to the treatment arm. Repetitive theta burst stimulation is delivered at 120% (or the nearest tolerated intensity) of the motor threshold up to five times a week for a total of 25 treatment visits. Previous interventions: Targeting is alternated every 5th treatment session between: 1. Regular targeting method based on scalp metrics 2. Individual targeting based on functional imaging The order of the targeting is randomized 1:1 according to a list for randomization. The patient and the research nurse who delivers treatment are blind to the treatment arm. Repetitive theta burst stimulation is delivered at 110% (or the nearest tolerated intensity) of the motor threshold up to five times a week for a total of 25 treatment visits. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Transcranial magnetic stimulation |
| Primary outcome measure | Depressive symptoms measured using the Beck's Depression Inventory-21 (BDI) at baseline, before 6th, 11th, 16th, and 21th and after 25th treatment visit |
| Secondary outcome measures | Depressive symptom reduction measured using a subjective Visual Analogue Scale (VAS) at baseline, before 6th, 11th, 16th, 21th and after 25th treatment visit |
| Overall study start date | 01/09/2022 |
| Overall study end date | 31/05/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 67 Years |
| Sex | Both |
| Target number of participants | 20 |
| Participant inclusion criteria | 1. Diagnosis of major depressive disorder (DSM-IV) as the principal diagnosis 2. Patient Health Questionnaire-9 score >14 3. Inability to tolerate antidepressant medication or unresponsiveness to minimum of two trials of more than 60 days with adequate dose of antidepressant 4. No change in antidepressive medication within four weeks prior to treatment |
| Participant 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 severe 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. Safety risks including active suicidality, pregnancy, magnetic metal or leads in the upper body, or history of seizures |
| Recruitment start date | 01/02/2025 |
| Recruitment end date | 31/12/2025 |
Locations
Countries of recruitment
- Finland
Study participating centre
Helsinki
PL590, 00029 HUS
Finland
Sponsor information
Hospital/treatment centre
Välskärinkatu 12, PL590
Helsinki
00029 HUS
Finland
| Phone | +358 0504631142 |
|---|---|
| piia.frondelius@hus.fi | |
| Website | https://www.helsinki.fi/fi/laaketieteellinen-tiedekunta/tutkimus/tieteenalat/psykiatrian-osasto |
"ROR" |
https://ror.org/020cpqb94 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- Suomen Akatemia, Finlands Akademi, Academy of Finland, AKA
- Location
- Finland
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Finnish Cultural Foundation, SKR
- Location
- Finland
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Jalmari and Rauha Ahokas Foundation
- Location
- Finland
Results and Publications
| Intention to publish date | 31/12/2026 |
|---|---|
| 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 publicly available due to the need to protect privacy of the participants. New researchers may however join the research group and use the data for scientific purposes. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 3 | 19/05/2023 | 11/08/2023 | No | Yes |
| Participant information sheet | version 4 | 17/12/2024 | 22/01/2025 | No | Yes |
Additional files
Editorial Notes
22/01/2025: The following changes were made to the study record:
1. Participant information sheet uploaded.
2. The scientific title was changed from 'Comparison of Helsinki individual targeting and regular targeting in bilateral TMS treatment of depression ' to 'Comparison of Helsinki individual targeting and regular targeting in TMS treatment of depression'.
3. The interventions were updated.
27/12/2023: The following changes have been made:
1. The recruitment start date has been changed from 01/09/2023 to 01/02/2025.
2. The recruitment end date has been changed from 31/12/2024 to 31/12/2025.
3. The overall study end date has been changed from 28/02/2025 to 31/05/2026 and the plain English summary updated accordingly.
4. The intention to publish date has been changed from 31/12/2025 to 31/12/2026.
11/08/2023: Study's existence confirmed by the HUS regional medical research ethics committee.
