Personalized neurostimulation for treatment-resistant OCD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effects of personalized responsive neurostimulation (RNS) therapy guided by stereoelectroencephalography (SEEG) in patients suffering from treatment-resistant obsessive-compulsive disorder (TR-OCD). It aims to identify effective stimulation targets in the brain to alleviate symptoms in patients who have not responded to traditional treatments. The study will also assess neuronal activity in specific brain regions during cognitive tasks and may include optional PET scanning to observe changes in brain activity due to stimulation. The goal is to evaluate both the safety and initial efficacy of this innovative approach.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. aged 18-65;
2. able to provide written informed consent;
3. have a diagnosis of OCD according to the Statistical Manual of Mental Disorders-Fourth Edition-Text Revised (DSM-IV-TR) criteria and confirmed by the Mini-International Neuropsychiatric Interview Chinese version 5.0;
4. have failed to improve despite undergoing two distinct courses of selective serotonin reuptake inhibitors (SSRIs), each lasting a minimum of 3-6 months; have failed to yield therapeutic efficacy after the administration of the maximum dose of clomipramine for 3-6 months in a single trial; without achieving effectiveness under cognitive behaviour therapy for six months; have failed to achieve therapeutic efficacy after three months of atypical antipsychotic medications, singularly or in combination with SSRIs or clomipramine.

Exclusion Criteria:

1. presence of other psychotic disorders;
2. have a treatment history that includes electroconvulsive therapy (ECT), modified electroconvulsive therapy (MECT), transcranial direct current stimulation (tDCS), transcranial alternating current stimulation (tACS), DBS, and transcranial magnetic stimulation (TMS);
3. presents a suicide risk (defined as a HAMD-17 score of ≥3 on suicide-related items);
4. experience difficulty in effectively communicating with investigators;
5. with a history of traumatic brain injury (TBI);
6. with intracranial or cardiovascular stents;
7. substance abuse within the past six months;
8. unstable neurological or coagulation disorders;
9. women who are pregnant, lactating, or of childbearing potential who refuse the use of reliable contraception during the study;
10. have been involved in other clinical studies within three months before enrollment in this study;
11. any conditions unsuitable for conducting this study program considered by the study group.

Where it's running

• Xuanwu Hospital, Capital Medical University
  Beijing, China Recruiting

Study contacts

• Principal investigator: Hongxing Wang, MD & PhD — Xuanwu Hospital, Beijing
• Study coordinator: Hongxing Wang, MD & PhD
• Email: wanghongxing@xwh.ccmu.edu.cn
• Phone: +861083198650

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.