Actively Recruiting
The Effect of Responsive Neurostimulation (RNS) in Treatment-resistant Obsessive-compulsive Disorder (TR-OCD)
Led by Xuanwu Hospital, Beijing · Updated on 2025-01-20
10
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effect of personalized responsive neurostimulation (RNS) guided by stereoelectroencephalography (SEEG) in adults with treatment-resistant obsessive-compulsive disorder (TR-OCD). The study aims to assess the safety and initial impact of this approach since many patients with OCD continue to experience symptoms despite drug treatments. The research also explores brain activity in specific regions linked to OCD and offers optional additional studies involving cognitive tasks and PET scans. Participants will have bilateral RNS leads implanted in targeted brain areas, including the ventral anterior limb of the internal capsule (vALIC), bed nucleus of the stria terminalis (BNST), anterior subthalamic nucleus (amSTN), ventral capsule/ventral striatum (VC/VS), and nucleus accumbens (NAc). The leads are fixed to the skull and connected to a neurostimulator implanted under the skin near the collarbone. Some participants may choose to participate in optional cognitive tasks or PET scans to further understand brain changes due to stimulation. During the study, participants will be regularly evaluated using various scales, including the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) to measure OCD symptoms over one year. Other assessments will track anxiety, depression, sleep quality, global impression of illness severity and improvement, quality of life, mania symptoms, and safety through monitoring adverse events. These evaluations will occur at multiple points up to 12 months, helping researchers understand treatment effects and participant safety over time.
CONDITIONS
Brief Title
RNS for Treatment-resistant Obsessive-compulsive Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 65 years
- Able to provide written informed consent
- Diagnosed with obsessive-compulsive disorder (OCD) according to DSM-IV-TR criteria and confirmed by Mini-International Neuropsychiatric Interview Chinese version 5.0
- Have not improved after two courses of selective serotonin reuptake inhibitors (SSRIs) lasting 3-6 months each
- Have not achieved therapeutic effect after maximum dose of clomipramine for 3-6 months
- Have not improved with cognitive behaviour therapy for six months
- Have not responded to three months of atypical antipsychotic medications alone or combined with SSRIs or clomipramine
You will not qualify if you...
- Presence of other psychotic disorders
- History of electroconvulsive therapy (ECT), modified ECT, transcranial direct or alternating current stimulation, deep brain stimulation (DBS), or transcranial magnetic stimulation (TMS)
- Suicide risk with HAMD-17 score of 3 or higher on suicide-related items
- Difficulty communicating effectively with investigators
- History of traumatic brain injury (TBI)
- Presence of intracranial or cardiovascular stents
- Substance abuse within the past six months
- Unstable neurological or coagulation disorders
- Women who are pregnant, breastfeeding, or of childbearing potential refusing reliable contraception
- Participation in other clinical studies within three months before enrollment
- Any condition deemed unsuitable for the study by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Procedure plus recovery period as per protocol
Participants undergo bilateral implantation of responsive neurostimulation (RNS) leads in specific brain targets, with the neurostimulator implanted under the skin near the collarbone.
1 surgical implantation visit and several follow-up visits for device adjustment
Duration - Up to 12 months
Participants receive responsive neurostimulation therapy targeting treatment-resistant obsessive-compulsive disorder with ongoing symptom assessments.
Visits at Week 2, Month 1, Month 3, Month 6, and Month 12 for assessments
Trial Site Locations
Total: 1 location
1
Xuanwu Hospital, Capital Medical University
Beijing, China, 100053
Actively Recruiting
Research Team
H
Hongxing Wang, MD & PhD
H
Huang Wang, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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