NCT04228744

Brief Summary

This study will evaluate the efficacy and explore the mechanism of deep brain stimulation (DBS) in the ventral internal capsule (VIC) and nucleus accumbens (NAc) for refractory obsessive-compulsive disorder (OCD).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2020

Completed
5 days until next milestone

Study Start

First participant enrolled

January 10, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 14, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

January 14, 2020

Status Verified

January 1, 2020

Enrollment Period

2 years

First QC Date

January 5, 2020

Last Update Submit

January 11, 2020

Conditions

Obsessive-Compulsive DisorderDeep Brain Stimulation

Outcome Measures

Primary Outcomes (1)

  • Change in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) score

    Y-BOCS is used to rate the severity of OCD symptoms by clinicians. Higher score means more severe OCD symptoms.

    Baseline (preoperative), 1 month, 3 months, 6 months, 12 months, 18 months

Secondary Outcomes (17)

  • Change in Yale-Brown Obsessive-Compulsive Scale-Self Report (Y-BOCS-SR) Score

    Baseline (preoperative), 1 month, 3 months, 6 months, 12 months, 18 months

  • Change in Yale-Brown Obsessive-Compulsive Scale-Second Edition (Y-BOCS-II) Score

    Baseline (preoperative), 1 month, 3 months, 6 months, 12 months, 18 months

  • Change in Obsessive-Compulsive Inventory - Revised (OCI-R) Score

    Baseline (preoperative), 1 month, 3 months, 6 months, 12 months, 18 months

  • Adverse Events

    Baseline (preoperative), 1 month, 3 months, 6 months, 12 months, 18 months

  • Changes in Hamilton Anxiety Scale Score

    Baseline (preoperative), 1 month, 3 months, 6 months, 12 months, 18 months

  • +12 more secondary outcomes

Study Arms (1)

Bilateral surgical implantation of DBS system

EXPERIMENTAL

All the participants will receive bilateral surgical implantation of DBS system to VIC and NAc. The experimenter will active the DBS system and adjust the parameters for all the participants after surgery.

Device: DBS system

Interventions

DBS systemDEVICE

The DBS device utilized in the present study includes a dual-channel neurostimulator kit, lead kit, extension kit, clinician-operated wireless programmer, test stimulator, and patient controller. The lead contains four stimulating contacts. The length of each contact is 1.5 mm, and the spacing between contacts is 1.5 mm. The participants will receive stepwise surgery. The electrodes will be implanted firstly which will be externalized for several days and then the IPG will be implanted. During externalization, the experimenters will record the local field potential and electroencephalography in resting or task-based state with conditions of sham-stimulation or active-stimulation.

Bilateral surgical implantation of DBS system

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of OCD with duration of at least 5 years;
  • Severity rated as severe to extreme illness;
  • Failed adequate trial of at least three specific serotonin reuptake inhibitor (SSRI) antidepressants;
  • Failed augmentation with antipsychotic;
  • Completed or failed to complete adequate trial of cognitive behavioural therapy for OCD;
  • Stable medication regimen for one month before surgery;
  • Signed informed consent;

You may not qualify if:

  • Hoarding as a primary symptom;
  • No other serious psychiatric disorder such as psychotic disorder;
  • Drug or substance use disorder within 6 months except nicotine;
  • Major Neurological/Medical condition;
  • High suicide risk;
  • Pregnancy or lactation;
  • Contraindications to stereotactic surgery;
  • Contraindications to MRI;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Study Officials

  • Bomin Sun, PhD

    Shanghai Jiao Tong University School of Medicine

    PRINCIPAL INVESTIGATOR

  • Valerie Voon, PhD

    University of Cambridge

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chencheng Zhang, PhD

CONTACT

+086-18217122884i@cczhang.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Functional Neurosurgery Department

Study Record Dates

First Submitted

January 5, 2020

First Posted

January 14, 2020

Study Start

January 10, 2020

Primary Completion

December 31, 2021

Study Completion

December 31, 2022

Last Updated

January 14, 2020

Record last verified: 2020-01

Locations

CN(1)