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RNS for Treatment-resistant Obsessive-compulsive Disorder
RECRUITINGN/ASponsored by Xuanwu Hospital, Beijing
Actively Recruiting
PhaseN/A
SponsorXuanwu Hospital, Beijing
Started2025-02-05
Est. completion2028-12-31
Eligibility
Age18 Years – 65 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06782867
Summary
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).
Eligibility
Age: 18 Years – 65 YearsHealthy volunteers accepted
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.
Conditions2
AnxietyObsessive Compulsive Disorder (OCD)
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Actively Recruiting
PhaseN/A
SponsorXuanwu Hospital, Beijing
Started2025-02-05
Est. completion2028-12-31
Eligibility
Age18 Years – 65 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06782867