RecruitingNot ApplicableNCT06341803

Personalized Transcranial Magnetic Stimulation Treatment for Depression


Sponsor

Institute of Mental Health, Singapore

Enrollment

20 participants

Start Date

Mar 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This proposal seeks to conduct a pragmatic single arm, open label pilot implementation to validate our individualized functional Magnetic Resonance Imaging (fMRI) connectome-guided localization approach for accelerated TMS among Asian patients with depression. Participants will be patients with Major Depressive Disorder not responding to standard treatment, with no exclusions to fMRI or transcranial magnetic stimulation (TMS) (essentially metal implants in the head) and willing to participate in the pilot. All participants will undergo MRI scans before and after the accelerated TMS treatment. The multi-session hierarchical Bayesian model (MS-HBM) approach will be used to estimate individualized connectome-guided target locations. Patients will undergo accelerated TMS applied to individualized connectome-guided target locations (based on the MS-HBM approach). Patients will undergo 10 sessions (each session lasting 10 min) spread out over 10 hours each day for 5 consecutive working days. All clinical outcome data will be collected for each patient by a pre-defined questionnaire at four time points: at baseline, post-treatment, 1 month and 3 months during follow-up. The clinical outcome data will be analyzed using linear regression or repeated analysis of variance (ANOVA) after adjusting for baseline clinical characteristics and socio-demographics. Trajectories of the clinical outcome data at baseline, post-treatment and all follow-up time points will be plotted and compared with time series statistical analysis models with the other clinical and socio-demographic characteristics included as confounders.


Eligibility

Min Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a personalized form of transcranial magnetic stimulation (TMS) — a non-invasive brain stimulation technique — that is tailored to each individual's brain scan to treat depression that hasn't responded to antidepressant medication. **You may be eligible if...** - You are 21 years of age or older - You have been diagnosed with a current major depressive episode - You have a moderately high depression score on a clinical scale (MADRS ≥ 20) - You have not responded well to at least one adequate trial of an antidepressant - You are able to give informed consent **You may NOT be eligible if...** - You have a psychotic disorder (like schizophrenia) - You have had drug or alcohol problems in the past 3 months - You are at high immediate risk of suicide - You have epilepsy or another significant neurological condition - You have metal in your skull, a pacemaker, cochlear implant, or medication pump - You are pregnant - You are unable to undergo MRI Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEIndividually Neuronavigated accelerated intermittent theta burst stimulation with Magpro X100

MagproX 100 and Axilium Cobot with Localite camera


Locations(1)

Institute of Mental Health

Singapore, Singapore

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06341803


Related Trials