RNS for Treatment-resistant Obsessive-compulsive Disorder

Recruiting now · Not applicable

Conditions studied: Obsessive-Compulsive Disorder (OCD)

In brief

The purpose of this study is to investigate the effect of personalized responsive neurostimulation (RNS) therapy guided by stereoelectroencephalography (SEEG) in patients with treatment-resistant obsessive-compulsive disorder (TR-OCD).

Key facts

Study ID

NCT06782867

Run by

Xuanwu Hospital, Beijing

People needed

10

Starts

2025-02-05

Expected to finish

2029-12-31

Last updated by the study team

2025-01-20

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• aged 18-65;
• able to provide written informed consent;
• 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;
• 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.

You may not qualify if…

• presence of other psychotic disorders;
• 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);
• presents a suicide risk (defined as a HAMD-17 score of ≥3 on suicide-related items);
• experience difficulty in effectively communicating with investigators;
• with a history of traumatic brain injury (TBI);
• with intracranial or cardiovascular stents;
• substance abuse within the past six months;
• unstable neurological or coagulation disorders;
• women who are pregnant, lactating, or of childbearing potential who refuse the use of reliable contraception during the study;
• have been involved in other clinical studies within three months before enrollment in this study;
• any conditions unsuitable for conducting this study program considered by the study group.

Where it is running

• Xuanwu Hospital, Capital Medical University — Beijing, China (enrolling)

Full record on ClinicalTrials.gov

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