RecruitingNot ApplicableNCT04982757

Accelerated TMS for Depression and OCD


Sponsor

Weill Medical College of Cornell University

Enrollment

500 participants

Start Date

Dec 7, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

Repetitive transcranial magnetic stimulation (rTMS) is a FDA-approved treatment for depression and Obsessive Compulsive Disorder (OCD). The goal of the study is to learn how to optimize the treatment to improve symptoms of depression and OCD. This research project will test a new accelerated 5-day accelerated rTMS protocol for treating symptoms of depression and OCD. A second goal of this study is to identify biomarkers of depression and OCD in the brain using functional magnetic resonance imaging (fMRI). This approach will predict who will benefit from TMS, determine the optimal treatment target, and improve treatment outcomes. Subjects will receive a clinical assessment of symptoms and an fMRI brain scan before and after each treatment course to measure the effect of treatment on symptom severity and on fMRI measures of functional connectivity. Participants will be randomized to receive rTMS targeting either the lateral prefrontal cortex (LPFC) or the dorsomedial prefrontal cortex (DMPFC). Participants will complete a 5-day course of rTMS delivered hourly for 10 hours per day. Participants who show a partial response to treatment but not a full response will then receive a second 5-day course. Treatment non-responders will be crossed over to receive rTMS targeting the opposite brain area. The primary hypothesis is that accelerated rTMS treatment will yield rapid improvement in symptoms for patients with depression and OCD in just 5 days, and that response rates can be further improved by adding a second 5-day treatment course.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an accelerated form of transcranial magnetic stimulation (TMS) — a non-invasive brain stimulation treatment that uses magnetic pulses to target specific brain areas — for people with treatment-resistant depression or obsessive-compulsive disorder (OCD). **You may be eligible if...** - You have been diagnosed with major depression or OCD - Your symptoms are moderate to severe on standard rating scales - You have tried at least one standard treatment (like an antidepressant or therapy) without adequate improvement, or you have refused standard treatments due to side effects - You are either not taking antidepressants or have been on a stable dose for at least 4 weeks **You may NOT be eligible if...** - You are at immediate risk of suicide - You have another major psychiatric diagnosis such as psychosis, PTSD, or bipolar disorder - You have a metal implant in your head or a pacemaker - You have a history of seizures 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.

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Interventions

DEVICEMagVenture MagPro System with Brainsight neuronavigation device

10x daily sessions of 1200 pulses of theta-burst stimulation lasting approximately ten minutes.


Locations(1)

Weill Cornell Medicine

New York, New York, United States

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NCT04982757


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