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China Refractory Obsessive-Compulsive Disorder Deep Brain Stimulation Study

NCT02398318 · Status: WITHDRAWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL

Last updated 2016-12-06

No results posted yet for this study

Summary

Refractory obsessive-compulsive disorder (OCD) is a disabling condition. Deep brain stimulation (DBS) of the nucleus accumbens is the most tested therapeutic avenue for refractory OCD. However, large scale randomized controlled trials to evaluate the effectiveness of this approach are rare.

Conditions

  • Obsessive Compulsive Disorder

Interventions

DEVICE

Bilateral Nucleus Accumbens DBS (Suzhou Sceneray)

High frequency stimulation applied using Suzhou Sceneray® DBS hardware (1120 electrode, 1180 (S) battery).

DEVICE

Sham Bilateral Nucleus Accumbens DBS

DBS system switched off.

Sponsors & Collaborators

  • Suzhou Sceneray Medical Co. , Ltd

    collaborator INDUSTRY

  • National Natural Science Foundation of China

    collaborator OTHER_GOV

  • Icahn School of Medicine at Mount Sinai

    collaborator OTHER

  • Ruijin Hospital

    lead OTHER

Principal Investigators

  • Bomin Sun, MD,PhD · Ruijin Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2016-10-31
Completion
2018-04-30

Countries

  • China

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02398318 on ClinicalTrials.gov