NCT07480408

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
31mo left

Started May 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress5%
May 2026Dec 2028

First Submitted

Initial submission to the registry

March 13, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 18, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

March 20, 2026

Status Verified

March 1, 2026

Enrollment Period

2.7 years

First QC Date

March 13, 2026

Last Update Submit

March 18, 2026

Conditions

Obsessive - Compulsive Disorder

Keywords

obsessive-compulsive disordersensory phenomenasupplementary motor areainsulaneuromodulation

Outcome Measures

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.

    Up to 6 days

Secondary Outcomes (8)

  • Change in Sensory Phenomena Scale (SPS) score

    Up to 6 days

  • Change in Beck Depression Inventory(BDI) score

    Up to 6 days

  • Change in Beck Anxiety Inventory (BAI) score

    Up to 6 days

  • Change in Perceived Stress Scale(PSS) score

    Up to 6 days

  • Change in Obsessive-Compulsive Inventory-Revised (OCI-R) score

    Up to 6 days

  • +3 more secondary outcomes

Study Arms (2)

online group

EXPERIMENTAL

The on-line group will watch body-focused sensory videos during each rTMS session.

Device: repetitive transcranial magnetic stimulation (rTMS)

off-line group

ACTIVE COMPARATOR

The off-line group will remain at rest during each rTMS sessions.

Device: repetitive transcranial magnetic stimulation (rTMS)

Interventions

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).

off-line grouponline group

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • OCD with abnormal sensory phenomena
  • 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.
  • Right-handed.
  • Either medication-free or on stable medication for at least 8 weeks.
  • OCD without abnormal sensory phenomena
  • 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.
  • Score ≤6 on the Sensory Phenomena Scale (SPS).
  • Right-handed.
  • Either medication-free or on stable medication for at least 8 weeks.

You may not qualify if:

  • 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.
  • History of epilepsy or any medical condition that may induce seizures or intracranial hypertension.
  • Contraindications to MRI, such as metallic implants.
  • Clinically significant medical illnesses or abnormal laboratory findings.
  • Inability to complete study procedures due to severe symptoms, low cognitive functioning, or poor cooperation.
  • No current or past psychiatric disorders meeting diagnostic criteria in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition.
  • Aged 18-55 years.
  • \. Pregnant women or women planning pregnancy in the near future. 2. History of epilepsy or any medical condition that may induce seizures or intracranial hypertension.
  • \. Presence of severe suicidal ideation or high suicide risk. 4. Contraindications to MRI, such as metallic implants. 5. Clinically significant medical illnesses or abnormal laboratory findings. 6. Inability to complete study procedures due to severe symptoms, low cognitive functioning, or poor cooperation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Mental Health Center

Shanghai, China

Location

MeSH Terms

Conditions

Compulsive Personality DisorderObsessive-Compulsive Disorder

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Personality DisordersMental DisordersAnxiety Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Central Study Contacts

Jiayue Cheng, Master

CONTACT

+8602134773503chengjy_94@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 13, 2026

First Posted

March 18, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

March 20, 2026

Record last verified: 2026-03

Locations

CN(1)