Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2026-01-02 @ 1:46 AM
Study NCT ID:
NCT05048251
Status:
RECRUITING
Last Update Posted:
2024-03-15
First Post:
2021-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Individually Targeted Neuromodulation for Contamination-based OCD
Sponsor:
Mclean Hospital
Organization:
Study Overview
Official Title:
Individually Targeted Neuromodulation for Contamination-based Obsessive-compulsive Disorder
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients with obsessive-compulsive disorder (OCD) experience a wide array of different types of obsessions and compulsions. However, current treatments for OCD employ a "one size fits all" approach and are used for all patients regardless of symptom type. In this project, the investigators propose to investigate whether a novel method of transcranial magnetic stimulation specifically reduces contamination/washing symptoms - one of the most common types of OCD.
Detailed Description:
The symptoms of obsessive-compulsive disorder (OCD) appear linked to dysfunction in a cortico-striato-thalamo-cortical circuit. However, obsessions and compulsions vary widely among OCD patients, suggesting that other symptom-specific brain networks may accompany this core defect. Identifying such networks could lead to personalized treatments, improving upon current "one size fits all" approaches.
Factor analyses have found distinct symptom dimensions in OCD, but the neural systems specific to these dimensions remain unclear. Using a novel, data-driven, individual-level approach to resting-state functional connectivity magnetic resonance imaging (fcMRI), the investigators have shown that increased connectivity between right medial frontal gyrus (R MFG) and brain regions within the ventral attention network (VAN) - regions critical to reorienting attention in response to relevant external stimuli - specifically predicted the severity of contamination/washing (CONTAM) symptoms, and attenuation of this hyperconnectivity following treatment was associated with improvement in CONTAM symptoms. Based on these findings, the investigators hypothesize that decreasing R MFG-VAN connectivity via transcanial magnetic stimulation (TMS) will normalize attentional reorienting and reduce CONTAM symptoms in individuals with contamination-based OCD.
The investigators propose a two-phase program to investigate R MFG-targeted TMS as a potential intervention for contamination-based OCD. First, in the currently study, the investigators will determine the optimal TMS paradigm to decrease R MFG-VAN connectivity by administering continuous, intermittent, and sham theta burst stimulation (cTBS, iTBS, sham) to individuals with contamination-based OCD using a novel individual-level approach to target the area of R MFG most strongly correlated with VAN based on each participant's pre-treatment connectivity data. Second, the investigators will use the TMS approach identified in this study to test the links between reduced R MFG-VAN connectivity, decreased VAN activation during attentional reorienting, and reduced CONTAM symptoms in a future study using a larger sample of OCD individuals with CONTAM.
Factor analyses have found distinct symptom dimensions in OCD, but the neural systems specific to these dimensions remain unclear. Using a novel, data-driven, individual-level approach to resting-state functional connectivity magnetic resonance imaging (fcMRI), the investigators have shown that increased connectivity between right medial frontal gyrus (R MFG) and brain regions within the ventral attention network (VAN) - regions critical to reorienting attention in response to relevant external stimuli - specifically predicted the severity of contamination/washing (CONTAM) symptoms, and attenuation of this hyperconnectivity following treatment was associated with improvement in CONTAM symptoms. Based on these findings, the investigators hypothesize that decreasing R MFG-VAN connectivity via transcanial magnetic stimulation (TMS) will normalize attentional reorienting and reduce CONTAM symptoms in individuals with contamination-based OCD.
The investigators propose a two-phase program to investigate R MFG-targeted TMS as a potential intervention for contamination-based OCD. First, in the currently study, the investigators will determine the optimal TMS paradigm to decrease R MFG-VAN connectivity by administering continuous, intermittent, and sham theta burst stimulation (cTBS, iTBS, sham) to individuals with contamination-based OCD using a novel individual-level approach to target the area of R MFG most strongly correlated with VAN based on each participant's pre-treatment connectivity data. Second, the investigators will use the TMS approach identified in this study to test the links between reduced R MFG-VAN connectivity, decreased VAN activation during attentional reorienting, and reduced CONTAM symptoms in a future study using a larger sample of OCD individuals with CONTAM.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: