RNS for Treatment-resistant Obsessive-compulsive Disorder

NCT06782867 | Recruiting

• 1 other identifier: RNS for TR-OCD
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Obsessive-Compulsive Disorder (OCD)

Keywords

OCD, RNS

Outcome Measures

Primary Outcomes (1)

• Yale-Brown Obsessive Compulsive Scale (Y-BOCS): the change from baseline to 1 year in the Y-BOCS total score

  The Y-BOCS scale is a clinician-rated, 10-item scale, each item rated from 0 (no symptoms) to 4 (extreme symptoms), yielding a total possible score range from 0 to 40. The total score is usually computed from the subscales for obsessions (items 1-5) and compulsions (items 6-10). The results can be interpreted based on the total score: 0-7 is sub-clinical; 8-15 is mild; 16-23 is moderate; 24-31 is severe; 32-40 is extreme.

  1 year

Secondary Outcomes (9)

• Yale-Brown Obsessive Compulsive Scale (Y-BOCS): remission, response, and partial response rate

  Week 2, Month 1, Month 3, Month 6, and Month 12

• Hamilton Anxiety Scale (HAMA): the change from baseline to 2 weeks, 1 month, 3 months, 6 months, and 1 year in the HAMA total score.

  Week 2, Month 1, Month 3, Month 6, and Month 12

• Hamilton Depression Rating Scale (HAMD-17): the changes of HAMD-17 scores and its subscales from baseline to 2 weeks, 1 month, 3 months, 6 months, and 1 year.

  Week 2, Month 1, Month 3, Month 6, and Month 12

• Pittsburgh Sleep Quality Index (PSQI): the change of PSQI from baseline to Week 2, Month 1, Month 3, Month 6, and Month 1.

  Week 2, Month 1, Month 3, Month 6, and Month 12

• Clinical Global Impression-Severity (CGI-S): the change from baseline to 2 weeks, 1 month, 3 months, 6 months, and 1 year in Clinical Global Impression-Severity (CGI-S)

  Week 2, Month 1, Month 3, Month 6, and Month 12

Study Arms (1)

treatment-resistant obsessive-compulsive disorder (TR-OCD)

EXPERIMENTAL

Patients will undergo bilateral RNS lead implantation.

Device: Responsive Neurostimulation (RNS)

Interventions

Responsive Neurostimulation (RNS) DEVICE

The RNS lead is stereotactically introduced into the target in the brain and fixed to the skull; the lead is then connected to a neurostimulator implanted subcutaneously in the subclavicular region.

treatment-resistant obsessive-compulsive disorder (TR-OCD)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, 100053, China

RECRUITING

MeSH Terms

Conditions

Obsessive-Compulsive Disorder; Raine syndrome

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Hongxing Wang, MD & PhD

  Xuanwu Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hongxing Wang, MD & PhD

CONTACT

+861083198650; wanghongxing@xwh.ccmu.edu.cn

Huang Wang, MD

CONTACT

+861083198650; wanghuang1118@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2025
• First Posted: January 20, 2025
• Study Start: February 5, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: January 20, 2025

Record last verified: 2025-01

Locations

CN (1)