RNS for Treatment-resistant Obsessive-compulsive Disorder

NCT ID: NCT06782867

Last Updated: 2025-01-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-05
• Study Completion Date: 2029-12-31

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).

Detailed Description

At least 40-60% of patients with obsessive-compulsive disorder (OCD) continue to have symptoms after drug treatment. There is still a lack of effective therapies for TR-OCD. In a comprehensive survey of diverse neuromodulation therapies, targeting specific nuclei with personalized responsive neurostimulation (RNS) is the most promising treatment for OCD with apparent symptoms, but the evidence remains limited. The stimulation targets of RNS for patients with TR-OCD include vALIC, BNST, amSTN, VC/VS, and NAc. The efficacy of RNS in treating OCD is closely related to precise target localization. While stereoelectroencephalography (SEEG) brain mapping can help identify Individualized effective targets and stimulation parameters. This project plans to conduct SEEG-guided RNS on TR-OCD patients to assess the safety and initial efficacy.

Another goal of this study is to examine the neuronal activity of the vALIC, BNST, amSTN, VC/VS, and NAc, respectively. At the same time, some subjects are presented with a task involving an unexpected reward and various cognitive tasks. This separate study is an option and will not affect current study participation.

Some participants will also be invited to join a related study that involves positron emission tomography (PET) scanning to determine how the stimulation changes activity in the brain. Participation in the separate PET study is optional and will not affect current study participation.

Conditions

Obsessive-Compulsive Disorder (OCD)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Patients will undergo bilateral RNS lead implantation.

Group Type: EXPERIMENTAL

Responsive Neurostimulation (RNS)

Intervention Type: 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.

Interventions

Responsive Neurostimulation (RNS)

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xuanwu Hospital, Beijing

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hongxing Wang, MD & PhD

Role: PRINCIPAL_INVESTIGATOR

Xuanwu Hospital, Beijing

Locations

Xuanwu Hospital, Capital Medical University

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Hongxing Wang, MD & PhD

Role: CONTACT

wanghongxing@xwh.ccmu.edu.cn

+861083198650

Huang Wang, MD

Role: CONTACT

wanghuang1118@163.com

+861083198650

Facility Contacts

Hongxing Wang, MD & PhD

Role: primary

wanghongxing@xwh.ccmu.edu.cn

01083198650

Other Identifiers

RNS for TR-OCD

Identifier Type: -

Identifier Source: org_study_id