Actively Recruiting
Effect of Personalized Responsive Neurostimulation (RNS) Guided by Stereoelectroencephalography in Treatment-resistant Obsessive-compulsive Disorder
Led by Xuanwu Hospital, Beijing · Updated on 2025-01-20
10
Participants Needed
1
Research Sites
255 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of personalized responsive neurostimulation (RNS) therapy guided by stereoelectroencephalography (SEEG) in adults aged 18 to 65 with treatment-resistant obsessive-compulsive disorder (TR-OCD). This condition affects many patients who do not improve after standard drug treatments, and new effective therapies are needed. The study focuses on targeting specific brain areas thought to influence OCD symptoms using RNS, a promising but still limitedly studied approach. The treatment involves placing an RNS lead into targeted brain regions, such as the ventral anterior limb of the internal capsule (vALIC), bed nucleus of the stria terminalis (BNST), anterior medial subthalamic nucleus (amSTN), ventral capsule/ventral striatum (VC/VS), and nucleus accumbens (NAc). The lead is connected to a neurostimulator implanted under the skin near the collarbone. Some participants may also take part in optional additional studies involving cognitive tasks and positron emission tomography (PET) scans to observe brain activity changes caused by the stimulation. Participants will be monitored over one year, with the main outcome being the change in symptoms measured by the Yale-Brown Obsessive Compulsive Scale (Y-BOCS). Researchers will assess safety and initial effectiveness while gathering data on brain activity. The study includes detailed brain mapping with SEEG to personalize treatment and may involve various assessments, interviews, and safety checks throughout the participation period.
CONDITIONS
Official 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 and confirmed by Mini-International Neuropsychiatric Interview
- Have not improved after two distinct courses of selective serotonin reuptake inhibitors (SSRIs), each lasting 3 to 6 months
- Have not improved after maximum dose of clomipramine for 3 to 6 months in a single trial
- Have not improved after cognitive behavior therapy for six months
- Have not improved after 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 treatments including electroconvulsive therapy (ECT), modified ECT, transcranial direct or alternating current stimulation, deep brain stimulation (DBS), or transcranial magnetic stimulation (TMS)
- Suicide risk defined as a 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, lactating, or of childbearing potential who refuse reliable contraception during the study
- Participation in other clinical studies within three months before enrollment
- Any condition deemed unsuitable for the study by the research team
AI-Screening
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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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