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Not Yet RecruitingNCT07480408

Neural Mechanisms of the Sensorymotor Circuit in Sensory Phenomena in OCD

Neural Mechanisms of the Insula-Supplementary Motor Area Circuit in Sensory Phenomena in Obsessive-Compulsive Disorder

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
120 (estimated)
Sponsor
Shanghai Mental Health Center · Academic / Other
Sex
All
Age
18 Years – 55 Years
Healthy volunteers
Accepted

Summary

The goal of this clinical study is to investigate the neural mechanisms of abnormal sensory phenomena in patients with Obsessive-Compulsive Disorder and to evaluate whether modulation of the insula-supplementary motor area circuit can improve these symptoms. The study will include adult patients with OCD (with or without sensory phenomena) and healthy volunteers. The main questions it aims to answer are: * Do patients with OCD show abnormal activity in the insula-SMA circuit compared with healthy controls? * Is this abnormality associated with the presence and severity of abnormal sensory phenomena? * Can low-frequency rTMS targeting the Supplementary Motor Area improve sensory phenomena and obsessive-compulsive symptoms? Researchers will compare an on-line rTMS group (viewing body-focused videos during stimulation) with an off-line rTMS group (resting during stimulation) to evaluate whether task engagement enhances treatment effects. Participants will: * Complete clinical assessments and behavioral tasks. * Undergo EEG and fMRI assessments. * Receive low-frequency rTMS targeting the Supplementary Motor Area. * Repeat assessments after the intervention.

Detailed description

Phase 1: This part adopts a cross-sectional design. A total of 30 patients with Obsessive-Compulsive Disorder with sensory phenomena, 30 OCD patients without sensory phenomena, and 30 healthy controls will be recruited. Clinical assessments will be conducted, including evaluation of the severity of sensory phenomena, as well as obsessive-compulsive, depressive, and anxiety symptoms. Resting-state functional magnetic resonance imaging (fMRI) and electroencephalography (EEG) data will be collected. In addition, during a body-focused video task designed to activate the insula-SMA circuit, task-based fMRI-EEG data will be simultaneously acquired. Phase 2: This part adopts a randomized parallel controlled design. Based on the 30 OCD patients with sensory phenomena included in Phase 1, an additional 30 patients will be recruited, resulting in a total of 60 OCD patients with sensory phenomena. After completing baseline clinical scale assessments, behavioral tasks, fMRI, and EEG data collection, participants will be randomly assigned to an on-line group or an off-line group. Both groups will receive low-frequency repetitive transcranial magnetic stimulation (rTMS) targeting the Supplementary Motor Area for six consecutive days, with five sessions per day. In the on-line group, participants will watch body-focused sensory videos during each stimulation session, whereas the off-line group will remain at rest during stimulation. After completion of the intervention, clinical scale assessments, behavioral tasks, and fMRI and EEG data collection will be repeated.

Conditions

Interventions

TypeNameDescription
DEVICErepetitive transcranial magnetic stimulation (rTMS)Repetitive transcranial magnetic stimulation (rTMS) will be delivered at 1 Hz with a total of 1,200 pulses per session, administered five times per day for six consecutive days. Target localization will be based on each participant's T1-weighted structural MRI, using a neuronavigation system to establish an individualized head model and identify the Supplementary Motor Area. The stimulation intensity will be set at 110% of the individual resting motor threshold (RMT).

Timeline

Start date
2026-05-01
Primary completion
2028-12-31
Completion
2028-12-31
First posted
2026-03-18
Last updated
2026-03-20

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT07480408. Inclusion in this directory is not an endorsement.