Submission date
26/01/2017
Registration date
11/04/2017
Last edited
27/12/2023
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
✓ Retrospectively registered
? Protocol not yet added
? SAP not yet added
? Results not yet added and study completed for more than 1 year
? Raw data not yet added
✓ Study completed

Plain English Summary

Background and study aims
Major depressive disorder (MDD) is one of the most common mental health conditions in the world. The symptoms can vary greatly from person to person, but they generally include low mood, problems with sleeping and/or eating, and a general loss of interest in life. Treatment often relies heavily on antidepressant medications, which work by increasing the activity and levels of a group of chemicals in the brain (neurotransmitters) and talking therapy. Repetitive transcranial magnetic stimulation (rTMS) is a relatively new treatment of depression. It involves using magnetic fields to stimulate brain cells in order to improve the symptoms of depression. Studies have shown that this treatment can produce changes in the brain that have been found to be related to mood regulation. This study is looking at the effects of targeting rTMS on a particular area of the brain.

Who can participate?
Patients with MDD aged between 15 and 60 years old.

What does the study involve?
All participants receive transcranial magnetic stimulation (rTMS) as a part of their normal care. During the first and sixth week of their treatment, participants are interviewed and asked to complete a questionnaire in order to assess the severity of their depression symptoms and their functioning, in order to find out whether the rTMS treatment has made any different to their condition.

What are the possible benefits and risks of participating?
There are no direct benefits involved with participating in this study. Strong magnetic fields used in MRI and TMS are a risk for patients with magnetic objects or medical devices in the body and so patients with these are unable to take part. There are no other notable risks involved with participating.

Where is the study run from?
Helsinki University Hospital (Finland)

When is the study starting and how long is it expected to run for?
January 2015 to January 2019

Who is funding the study?
Helsinki University Hospital (Finland)

Who is the main contact?
Dr Tuukka Raij

Study website

Contact information

Type

Scientific

Contact name

Dr Tuukka Raij

ORCID ID

http://orcid.org/0000-0002-9834-5570

Contact details

PL 348
Helsinki
00029 HUS
Finland

Additional identifiers

EudraCT/CTIS number

IRAS number

ClinicalTrials.gov number

Protocol/serial number

05012017

Study information

Scientific title

Imaging-based optimization of repetitive transcranial magnetic stimulation for depression

Acronym

Study hypothesis

Effectiviness of rTMS treatment of depression depends on E-field location in the left dorsolateral cortical region.

Ethics approval(s)

Helsinki University Hospital Ethics Committee for gynaecology and obstetrics, pediatrics and psychiatry, 11/06/2015, ref: 215/13/03/03/2015

Study design

Observational cohort study

Primary study design

Observational

Secondary study design

Cohort study

Study setting(s)

Hospital

Study type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Major depression

Intervention

The brain stimulation treatment and whole-head MRI is part of the normal clinical care of the patients. For the study purposes, location of the stimulating coil is registered to enable computation of stimulation-induced electric fields and to compare the cortical distribution of the fields with treatment response. Patients admitted to the Helsinki University Central Hospital (HUCH) Aurora neuromodulation unit for treatment of MDD with repetitive transcranial magnetic stimulation (rTMS) are first contacted by phone to inquire about their interest in participating in the study. At the first study visit, participants sign informed consent, fill in the patient health questionnaire-9 (phq-9, assessing symptoms of depression), and are evaluated by the study psychiatrist. The evaluation includes the Mini-International Neuropsychiatric Interview (MINI) for diagnostics, Montgomery–Åsberg Depression Rating Scale (MADRS), Social and Occupational Functioning Assessment Scale (SOFAS), and determination of the patient's TMS motor threshold, which is used to customize the rTMS intensity. TMS coil is placed over the EEG electrode location F5 situated over the left dorsolateral prefrontal cortex, and a mark for the coil position is saved in the neuronavigation system. On the subsequent 23 visits, rTMS is applied at the marked position using a TMS neuronavigation system. Exact coil position with respect to the anatomical MRI is recorded during all TMS sessions. TMS is given with a Magstim Rapid stimulator at 110-120% of motor threshold, (4-second trains of 40 pulses at 10 Hz, interleaved with 26-s waiting periods), on 3-5 times days per week at weeks 1-4, on two days at week 5, and once at week 6. At the end of the last rTMS visit at week 6 the participants again fill in the phq-9 and meet the psychiatrist for MADRS and SOFAS assessments. There is no follow-up in the study.

Intervention type

Device

Pharmaceutical study type(s)

Phase

Not Applicable

Drug/device/biological/vaccine name(s)

Transcranial magnetic stimulation

Primary outcome measure

Depression severity is measured using the Montgomery-Åsberg Depression Rating Scale (MADRS) total at week 1 and 6.

Secondary outcome measures

1. Depression severity is measured using The Patient Health Questionnaire (PHQ-9) at week 1 and 6
2. Functioning is measured using Social and Occupational Functioning Assessment Scale (SOFAS) at week 1 and 6

Overall study start date

01/01/2015

Overall study end date

31/01/2023

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Major depressive disorder in MINI interview
2. Aged 15-60 years

Participant type(s)

Patient

Age group

Mixed

Lower age limit

15 Years

Upper age limit

60 Years

Sex

Both

Target number of participants

70

Participant exclusion criteria

1. Serious psychiatric or somatic illness
2. MRI/TMS contraindications

Recruitment start date

01/05/2016

Recruitment end date

31/10/2022

Locations

Countries of recruitment

Finland

Study participating centre

Helsinki University Hospital
Aurora ECT unit
Helsinki
00029 HUS
Finland

Sponsor information

Organisation

Helsinki University Hospital

Sponsor details

PL590
Helsinki
00029 HUS
Finland

Sponsor type

Hospital/treatment centre

Website

http://www.hus.fi/en/Pages/default.aspx

ROR

https://ror.org/02e8hzf44

Funders

Funder type

Hospital/treatment centre

Funder name

Helsinki University Hospital

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in an international peer reviewed journal.

Intention to publish date

31/05/2025

Individual participant data (IPD) sharing plan

The datasets generated during and/or analysed during the current study are not expected to be made available to protect patient identity.

IPD sharing plan summary

Not expected to be made available

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?

Additional files

Editorial Notes

27/12/2023: The intention to publish date has been changed from 31/12/2023 to 31/05/2025. 09/01/2019: The following changes have been made: 1. The recruitment end date has been updated from 31/12/2018 to 31/10/2022. 2. The overall trial end date has been updated from 31/01/2019 to 31/01/2023. 3. The intention to publish date has been updated from 31/12/2020 to 31/12/2023.