Neuroimaging Biomarkers for Predicting rTMS Response in OCD

Status Recruiting

Clinical Trial Summary

This study evaluates an accelerated schedule of theta-burst stimulation using a Transcranial Magnetic Stimulation (TMS) device for treatment-resistant Obsessive Compulsive Disorder (OCD). In a randomized fashion, half the participants will receive accelerated theta-burst stimulation at the dorsomedial prefrontal cortex (DMPFC), while half will receive accelerated theta-burst stimulation at the right orbitofrontal (rOFC) site.

Clinical Trial Description

Medications (SSRIs and D2 antagonists) and cognitive-behavioral therapy are the mainstays of treating OCD; however, many patients show only a partial response, and more than 25% of patients show no improvement with these treatments. Repetitive transcranial magnetic stimulation (rTMS) is a promising alternative, using powerful, focused magnetic field pulses to stimulate target brain areas. So far, at least two stimulation targets have consistent evidence of efficacy in OCD: the dorsomedial prefrontal cortex (DMPFC) and the orbitofrontal cortex (OFC). Patients often show a strong response to one target but not the other. It is not well understood why some patients respond, while others do not. The investigators previously developed methods for discovering neurophysiological subtypes of depression based on resting state functional Magnetic Resonance Imaging (fMRI) measures of functional connectivity (RSFC) in relevant brain networks; diagnosing them in individual patients; and using them to predict individual differences in rTMS response. Subsequently, motivated by recent studies characterizing individual variability in the topology of these functional networks, the investigators have optimized methods for improving the accuracy of these predictions by accounting for individual variability, stabilizing the selection of treatment-predictive features, and increasing robustness in replication samples through regularization. Here, the investigators propose applying these methods to discover novel network-based subtypes of OCD and develop prognostic neuroimaging biomarkers for predicting differential treatment response to rTMS targeting the DMPFC or OFC, which could subsequently be tested in a randomized clinical trial. ;

Study Design

Related Conditions & MeSH terms

Obsessive-Compulsive Disorder

Clinical Trial Details

NCT number	NCT04286126
Study type	Interventional
Source	Stanford University
Contact	Nick Bassano, MSW
Phone	650-497-3933
Email	nbassano@stanford.edu
Status	Recruiting
Phase	N/A
Start date	January 15, 2021
Completion date	December 15, 2025

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.