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Clinical Trials in China / NCT06360991
Starting soon Not applicable

DBS for Treatment-resistant Obsessive-compulsive Disorder

NCT06360991 · tracked via the Priya Life Science China tracker
Sponsor
Xuanwu Hospital, Beijing
Phase
Not applicable
Started
2024-04-20
Last updated
2024-04-11

Condition(s) studied

Obsessive-Compulsive Disorder (OCD)

Investigational drug(s) / intervention(s)

Deep brain stimulation (DBS)

Deep brain stimulation (DBS): The DBS lead is stereotactically introduced into the target in the brain (vALIC, BNST, amSTN, VC/VS, or NAc) and fixed to the skull; the lead is then connected to a neurostimulator implanted subcutaneously in the subclavicular region.

Study summary

The primary purpose of this study is to investigate the effect of deep brain stimulation (DBS) implantation targeting the anteromedial region of subthalamic nucleus (amSTN), or nucleus accumbens (NAc), or bed nucleus of the stria terminalis (BNST), or ventral capsule/ventral striatum (VC/VS), or the ventral anterior limb of the internal capsule (vALIC) in patients with treatment-resistant obsessive-compulsive disorder (TR-OCD).

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Xuanwu Hospital, Capital Medical University Beijing China

More Xuanwu Hospital, Beijing trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06360991 on ClinicalTrials.gov ↗ ← All trials in China