A Novel Individualized Connectome-guided Approach for Precision Intermittent Theta Burst Stimulation for Depression
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Beam F3 targeted accelerated iTBS, Individualized connectome-guided accelerated iTBS.
- Who it may be relevant to
- Registry conditions: Depression. Basic parameters: from 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Singapore
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Novel Individualized Connectome-guided Approach for Precision Intermittent Theta Burst Stimulation for Depression: a Double Blind, Randomized Controlled Trial
Overview
The Investigators propose to carry out a randomized, double-blind trial to compare the clinical efficacy of an individualized connectome-guided accelerated iTBS vs an anatomically-guided (Beam F3) accelerated iTBS. The study team will recruit both inpatients and outpatients who had been referred for TMS for the treatment of depression.
Interventions
- Device Beam F3 targeted accelerated iTBS
Magpro X100, Axilium Cobot, Localite camera - Device Individualized connectome-guided accelerated iTBS
Magpro X100, Axilium Cobot, Localite camera
Primary outcome measures
- Montgomery-Åsberg Depression Rating Scale [Time frame: Baseline, immediately post treatment, 1 month and 3 months post intervention]
Secondary outcome measures (4)
- Quick Inventory of Depressive Symptomatology (16-Item) (Self-Report) [Time frame: Baseline, daily during treatment (5 days), immediately post treatment, 1 month and 3 months post intervention]
- Montreal Cognitive Assessment (MoCA) [Time frame: Baseline, immediately post treatment, 1 month and 3 months post intervention]
- EQ-5D (EuroQol) [Time frame: Baseline, immediately post treatment, 1 month and 3 months post intervention]
- Quality of Life Enjoyment and Satisfaction Questionnaire Short form (Q-LES-QS-SF) [Time frame: Baseline, immediately post treatment, 1 month and 3 months post intervention]
Eligibility criteria
Inclusion criteria
- Age ≥ 21 years.
- DSM-5 diagnosis of current Major Depressive Episode.
- Montgomery-Asberg Depression Rating Scale score of 20 or more.
- Inadequate response to an adequate trial (4 weeks) of at least one antidepressant medication.
- Able to give informed consent.
Exclusion criteria
- DSM-5 psychotic disorder
- Drug or alcohol abuse or dependence (preceding 3 months).
- Rapid clinical response required, e.g., high suicide risk.
- Significant neurological disorder, which may pose increased risks with TMS, e.g., epilepsy.
- Metal in the cranium, skull defects, pacemaker, cochlear implant, medication pump or other electronic device.
- Pregnancy.
- Unsuitable for MRI.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Singapore · 1 center
- Institute of Mental Health — Singapore
Identifiers
NCT: NCT06385223 · DSRB 2023/00680