Actively Recruiting
A Study on the Efficacy and Safety of Accelerated Transcranial Magnetic Stimulation for Obsessive-Compulsive Disorder and Its Underlying Neurological Mechanisms
Led by Shanghai Pudong New Area Mental Health Center, School of Medicine, Tongji University · Updated on 2025-09-30
20
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether individualized accelerated repetitive transcranial magnetic stimulation (rTMS) targeting the inferior frontal cortex combined with symptom provocation can relieve obsessive-compulsive disorder (OCD) symptoms in adults. The study also aims to assess the safety of rTMS applied to the right inferior frontal cortex. It focuses on adults with OCD resistant to standard treatments and seeks to answer questions about symptom relief and medical problems during rTMS treatment. Participants will receive rTMS six times daily for five consecutive days, targeting a personalized area of the inferior frontal cortex while provoking symptoms. The study involves a baseline clinic visit, treatment days, and follow-up visits on the day after treatment and four weeks later. The approach uses a non-invasive brain stimulation technique designed to assess its effects on OCD symptoms. During the study, participants will undergo evaluations including symptom severity assessments using the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) from baseline up to six months after treatment. Additional tests include safety monitoring for adverse events, depression and anxiety scales, clinical efficacy measures, neuroimaging by MRI, cognitive function tasks, and self-rated questionnaires. Participants will be closely monitored through clinic visits and various assessments over the study period.
CONDITIONS
Brief Title
Accelerated rTMS Therapeutic Approach for Refractory Obsessive-Compulsive Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Volunteer subjects with Obsessive Compulsive Disorder (OCD) according to DSM V criteria
- Without associated tics (no Gilles de la Tourette Syndrome)
- Age between 18 and 60 years
- Right-handed
- Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score of 16 or higher
- Stable medication for at least 4 weeks
- Resistant to standard treatments with partial or no sufficient response
- No systematic rTMS therapy in the past six months
- Signed informed consent
- Normal vision or corrected vision
- Capacity to complete protocol-specified tests
You will not qualify if you...
- Abnormal cognitive status (MoCA score below 24)
- Primary diagnosis other than OCD (mild depression allowed)
- Comorbid schizophrenia, psychotic disorder, bipolar disorder, substance abuse, or dependence
- Significant self-harm intent or severe suicidal tendencies within the past year
- Irreversible visual or auditory impairment preventing assessments
- Presence of metallic implants like pacemakers or stents
- Medical, psychological, social, or geographical factors compromising safety or participation
- Poor compliance
- Claustrophobia
- History of epilepsy or family history of epilepsy
- Pregnant or lactating women; negative pregnancy test and contraception required for women of childbearing potential
- Deterioration or failure of vital organ functions or unstable vital signs
- Conditions unsuitable for stimulation site such as increased intracranial or intraocular pressure, glaucoma
- History or presence of neurological disorders including cerebrovascular disease, CNS infections, Creutzfeldt-Jakob disease, Huntington's disease, Parkinson's disease, Lewy body dementia, traumatic brain injury dementia, substance-related encephalopathy, intracranial space-occupying lesions, endocrine disorders, or dementia due to vitamin deficiency or other causes
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration not specified
Participants receive individualized rTMS targeting the IFC with symptom provocation as an active treatment for Obsessive-Compulsive Disorder.
Visit schedule not specified
Duration - Up to 6 months after treatment
Participants are monitored for safety and efficacy outcomes including symptom severity and neurological assessments after completing treatment.
Visits occur up to 6 months post-treatment with assessments at baseline and follow-up timepoints
Trial Site Locations
Total: 1 location
1
Shanghai Pudong New Area Mental Health Centre
Shanghai, Shanghai Municipality, China, 200124
Actively Recruiting
Research Team
Y
Yijie Zhao
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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