Shanghai Mental Health Center
Shanghai, China
NCT Number: NCT07480408
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.
Trial opening soon.
Get Notified18 year–55 year
All sexes
Interventional
Not applicable
Shanghai, China
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
OCD with abnormal sensory phenomena
OCD without abnormal sensory phenomena
Exclusion criteria
Healthy Controls Inclusion criteria
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).
Time frame: Up to 6 days
It assesses the severity of OCD symptoms. The Y-BOCS scale ranges from 0 to 40, with 0 being no symptoms and 40 being severe.
Time frame: Up to 6 days
A semi-structured scale used to assess the presence and severity of sensory phenomena occurring before or during repetitive behaviors. It consists of two parts: a symptom checklist and a severity rating.
Time frame: Up to 6 days
It consists of 21 items and uses a 0 to 3 severity scale. Total scores range from 0 to 63, with higher scores indicating more severe depression symptoms.
Time frame: Up to 6 days
It is an inventory of anxiety symptoms with 18 items that are rated on a 5-point Likert scale(0 to 4). Total scores range from 0 to 72, with higher scores indicating more severe anxiety symptoms.
Time frame: Up to 6 days
It is a 10-item, 5-point Likert scale(0 to 4) to measure the degree to which situations in one's life are appraised as stressful.The total score ranges from 0 to 40, with lower total scores representing a better outcome.
Time frame: Up to 6 days
It is a self-report instrument derived from the original 42-item OCI for assessing obsessive-compulsive symptoms. It contains 18 items divided into six subscales, each with three items, assessing six symptom dimensions: washing, obsessing, hoarding, ordering, checking, and neutralizing. Each item is rated on a 5-point scale from 0 to 4, with higher scores indicating more severe symptoms.
Time frame: Up to 6 days
This scale consists of 44 items and includes three factors: responsibility/threat estimation, perfectionism/certainty, and importance/control of thoughts.
Time frame: Up to 6 days
This scale consists of 12 items rated on a 5-point Likert scale ranging from "strongly disagree" to "strongly agree." Higher scores indicate lower tolerance of uncertainty. The scale includes two dimensions: inhibitory anxiety and prospective anxiety.
Time frame: Up to 6 days
This scale is used to assess the presence and severity of Not Just Right Experiences in individuals.
Contact information is provided by the study sponsor or research team.
Shanghai Mental Health Center
Other
Neural Mechanisms of the Insula-Supplementary Motor Area Circuit in Sensory Phenomena in Obsessive-Compulsive Disorder
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