Personalized neurostimulation for treatment-resistant OCD

The Effect of Responsive Neurostimulation (RNS) in Treatment-resistant Obsessive-compulsive Disorder (TR-OCD)

This study is testing a new brain stimulation therapy for people with obsessive-compulsive disorder who haven't found relief from other treatments to see if it can help reduce their symptoms.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Xuanwu Hospital, Beijing (other)
• Locations: 1 site (Beijing)
• Trial ID: NCT06782867 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-65 with a diagnosis of OCD who have not responded to multiple standard treatments.

Not a fit: Patients with other psychotic disorders or those who have undergone electroconvulsive therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could provide a new treatment option for patients with treatment-resistant OCD, potentially improving their quality of life.

How similar studies have performed: While there is limited evidence for the efficacy of RNS in OCD, similar neuromodulation approaches have shown promise in other conditions.

Eligibility criteria

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 this trial is running

Beijing

• 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

Conditions: Obsessive-Compulsive Disorder, OCD, RNS