RNS for Treatment-resistant Obsessive-compulsive Disorder
Recruiting · NCT06782867 · Interventional (participants receive a specific treatment) · Lead sponsor: Xuanwu Hospital, Beijing
View the official record on ClinicalTrials.gov →Interventions studied
Responsive Neurostimulation (RNS)
What this trial is about
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).
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
Exclusion criteria
- 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
1 location listed.
- Xuanwu Hospital, Capital Medical University - Beijing, China