Localization of transcranial magnetic stimulation in treatment of depression

• Register: ISRCTN
• Last refreshed on: 8 January 2024
• Main ID: ISRCTN63779759
• Date of registration: 11/04/2017
• Prospective Registration: No
• Primary sponsor: Helsinki University Hospital
• Public title: Localization of transcranial magnetic stimulation in treatment of depression
• Scientific title: Imaging-based optimization of repetitive transcranial magnetic stimulation for depression
• Date of first enrolment: 01/05/2016
• Target sample size: 70
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN63779759
• Study type: Observational
• Study design: Observational cohort study (Treatment)
• Phase: Not Applicable

Countries of recruitment

Finland

Contacts

• Name: Tuukka Raij

Key inclusion & exclusion criteria

Inclusion criteria: 1. Major depressive disorder in MINI interview
2. Aged 15-60 years
Exclusion criteria: 1. Serious psychiatric or somatic illness
2. MRI/TMS contraindications

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Major depression
Mental and Behavioural Disorders
Major depression

Intervention(s)

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 me

Primary Outcome(s)

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

Secondary Outcome(s)

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

Secondary ID(s)

05012017

Source(s) of Monetary Support

Helsinki University Hospital

Ethics review

Status:
Approval date:
Contact:

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

Results

• Results available: Yes
• Date Completed: 31/01/2023