Guided rTMS therapy for treatment-resistant OCD
Personalized Brain Functional Sectors (pBFS) Guided rTMS Therapy for Treatment-resistant Obsessive-Compulsive Disorder: A Randomized, Double-Blind, Sham-controlled Trial
This study is testing a new type of brain stimulation therapy to see if it can help people with OCD who haven't found relief from other treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Changping Laboratory Academic / other |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT05964049 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of pBFS-guided rTMS therapy targeting the dorsolateral prefrontal cortex (DLPFC) in patients with treatment-resistant Obsessive-Compulsive Disorder (OCD). The approach utilizes precise targeting of neural circuitry associated with OCD symptoms, aiming to enhance the effectiveness of rTMS treatment. Participants will undergo a screening process to determine eligibility, followed by randomization into active or sham treatment groups. The hypothesis is that targeted rTMS will significantly reduce clinical symptoms in this patient population.
Who should consider this trial
Good fit: Ideal candidates are hospitalized or outpatient adults aged 18-65 with a diagnosis of OCD who have not responded adequately to previous treatments.
Not a fit: Patients with OCD who have not undergone prior treatment or those who do not meet the eligibility criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a new effective treatment option for patients suffering from treatment-resistant OCD.
How similar studies have performed: Previous studies have shown varying success with rTMS targeting different brain regions, but this specific approach using pBFS is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Hospitalized/outpatient patients aged 18-65 years (inclusive), male or female. * Meet the diagnostic criteria of DSM-5(Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition) for obsessive-compulsive disorder, and currently experiencing a first or recurrence episode. * Total Y-BOCS score ≥20 and total HAMD score \<17 before randomization. * Before randomization, patients must have received a minimum of 2 months of maintenance treatment with SSRI medication prior to randomization, or have undergone maintenance CBT treatment with inadequate response to SSRI medication (less than 50% symptom improvement), or have previously shown inadequate response (less than 50% symptom improvement) to at least one trial of SSRI medication or cognitive-behavioral therapy. Patients currently taking medication should have been on a stable dose for 8 weeks. * Voluntarily participate in the trial and sign informed consent. Able to comply with the planned visit, examination and treatment plan, and other study procedures. Exclusion Criteria: * Meet DSM-5 diagnostic criteria for other mental disorders (such as schizophrenia, schizoaffective disorder, post-traumatic stress disorder, bipolar disorder, and secondary depression, etc.); * Patients with a cardiac pacemaker, cochlear implant, or other metal foreign body and any electronic equipment implanted in the body, patients with claustrophobia and other contraindications to magnetic resonance scanning, and patients with contraindications to rTMS treatment; * History of epilepsy (presence of at least 2 uninduced seizures more than 24 hours apart, or diagnosis of the epileptic syndrome, or seizures within the past 12 months); Or currently received medications or other treatments that will lower the seizure threshold; * History of ECT, rTMS, light therapy within 3 months; * Patients with organic brain diseases (such as ischemic stroke, cerebral hemorrhage, brain tumor, etc.) and a history of severe brain trauma as judged by the researcher; * Patients with serious or unstable diseases of the cardiovascular, liver, kidney, blood, endocrine, neurological system, and other systems or organs. * Female of childbearing potential who plans to become pregnant during the trial. Female that is pregnant or breastfeeding. * Substance abuse or dependence (including alcohol, drugs, and other psychoactive substances) in the past 6 months. * First-degree relatives have bipolar affective disorder and schizophrenia. * There is a significant risk of suicide (MADRS item 3 ≥ 3). * Difficulty or inability to engage in normal communication, understand or follow instructions, and cooperate with treatment and evaluators. * Patients in any clinical trials of other drugs or physical therapy ( DBS, ECT, rTMS) within 1 month before the screening * Investigators think that was inappropriate to participate.
Where this trial is running
Beijing, Beijing
- Peking University Six Hospital — Beijing, Beijing, China (Recruiting)
Study contacts
- Study coordinator: Meiling Li, Ph.D.
- Email: meilingli@cpl.ac.cn
- Phone: 010-80726688
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.