Accelerated rTMS Therapeutic Approach for Refractory Obsessive-Compulsive Disorder

NCT ID: NCT07198594

Last Updated: 2025-09-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-03
• Study Completion Date: 2027-12-31

Brief Summary

The goal of this clinical trial is to learn if individualized accelerated repetitive transcranial magnetic stimulation (rTMS) targeting the inferior frontal cortex combined with symptom provocation works to treat obsessive-compulsive disorders (OCD) in adults. It will also learn about the safety of rTMS over right IFC. The main questions it aims to answer are:

• Does rTMS using a new individualized IFC target relieve participants' OCD symptoms?
• What medical problems do participants have when taking rTMS?

Participants will:

• Take rTMS six times per day for 5 consecutive days
• Visit the clinic once at baseline, the day and four weeks after treatment for checkups and tests

Conditions

Obsessive Compulsive Disorder (OCD); Obsessive - Compulsive Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

rTMS

individualized rTMS targeting IFC, with symptom provocation

Group Type: EXPERIMENTAL

rTMS

Intervention Type: OTHER

individualized rTMS target the IFC with symptom provocation

Interventions

rTMS

individualized rTMS target the IFC with symptom provocation

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Volunteer subjects with Obsessive Compulsive Disorders (OCD) according to the Diagnostic and Statistical Manual of Mental Disorders (DSM V) criteria
• without associated tics ("Gilles de la Tourette" Syndrome)
• Age 18-60 years, right-handed
• Disease severity: Yale-Brown Obsessive Compulsive Scale score ≥16 for OCD patients
• Medication stable for at least 4 weeks
• Resistant patients to standard treatments: partial but insufficient response (reduction of Y-BOCS score < 35%) or lack of response to previous well conducted treatment including: optimal tolerated dose and adequate duration (> 12 weeks) of at least 2 Serotonin Reuptake Inhibitors (selective serotonin reuptake inhibitors, clomipramine), or 1 Serotonin Reuptake Inhibitors + 1 augmentation strategy (adjunction of an antipsychotic - such as risperidone or olanzapine or aripiprazole - or lithium or buspirone)
• No systematic rTMS therapy in the past six months;
• Signature of informed consent form;
• Normal vision or corrected vision;
• Capacity to complete protocol-specified tests.

Exclusion Criteria

• Abnormal cognitive status (assessed using MoCA with score <24);
• Other primary diagnosis than OCD (comorbid mild depression is tolerated)
• Comorbid diagnosis of schizophrenia/ psychotic disorder, bipolar disorder, substance abuse or dependance3)
• Significant self-harm intent or severe suicidal tendencies within the past year;
• Irreversible visual or auditory impairment preventing completion of scales or related assessments;
• Presence of metallic implants, such as pacemakers or stents;
• Any current or potential medical, psychological, social, or geographical factors compromising patient safety or study participation;
• Poor compliance;
• Claustrophobia;
• History of epilepsy or familial epilepsy
• Pregnant or lactating women (women of childbearing potential must obtain a negative pregnancy test result prior to study commencement and employ medically approved contraceptive measures);
• Deterioration or failure of vital organ function (cardiac, pulmonary, hepatic, renal, etc.); or unstable vital signs;
• Conditions unsuitable for this stimulation site, such as increased intracranial pressure, elevated intraocular pressure, or glaucoma
• History of or concomitant neurological disorders: cerebrovascular disease, central nervous system infections, Creutzfeldt-Jakob disease, Huntington's disease and Parkinson's disease, Lewy body dementia, traumatic brain injury dementia, other physical/chemical factors (drugs, alcohol, CO, etc.), significant somatic diseases (hepatic encephalopathy, pulmonary encephalopathy, etc.), intracranial space-occupying lesions (subdural haematoma, brain tumours), endocrine system disorders (thyroid disease, parathyroid disease), and dementia caused by vitamin deficiency or any other cause

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Pudong New Area Mental Health Center, School of Medicine, Tongji University

OTHER

Sponsor Role: lead

Responsible Party

zhaoyijie

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shanghai Pudong New Area Mental Health Centre

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yijie Zhao

Role: CONTACT

yj_zhao@tongji.edu.cn

+86 13585960699

Facility Contacts

Ruiqin Chen

Role: primary

chenrq@shspdjw.com

+86 13917451850

Provided Documents

Document Type: Study Protocol and Informed Consent Form

View Document

Other Identifiers

PDJW-KY-2025-017

Identifier Type: -

Identifier Source: org_study_id