Neural Mechanisms of the Sensorymotor Circuit in Sensory Phenomena in OCD

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorShanghai Mental Health Center

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Meet the diagnostic criteria for Obsessive-Compulsive Disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition.

Aged 18-55 years.

Score ≥16 on the Yale-Brown Obsessive Compulsive Scale, indicating moderate to severe symptoms.

Score >6 on the Sensory Phenomena Scale (SPS), indicating moderate to severe sensory phenomena.

Disqualifiers

Meeting diagnostic criteria in Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition for psychiatric disorders other than OCD or obsessive-compulsive personality disorder.

OCD symptoms so severe that required assessments cannot be completed.

Presence of severe suicidal ideation or high suicide risk.

Pregnant women or women planning pregnancy in the near future.

Trial design

Design model

Parallel

Treatments tested in this trial

  • repetitive transcranial magnetic stimulation (rTMS)

    Device

    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).

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: online groupExperimental treatment 1 intervention
Group B: off-line groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Yale-Brown Obsessive Compulsive Scale(Y-BOCS) score

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

Secondary outcomes

1

Change in Sensory Phenomena Scale (SPS) score

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
2

Change in Beck Depression Inventory(BDI) score

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
3

Change in Beck Anxiety Inventory (BAI) score

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
4

Change in Perceived Stress Scale(PSS) score

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

Other outcomes

Sponsors and contacts

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