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Deep Brain Stimulation of Nucleus Accumbens for Opioid Relapse Prevention

NCT03424616 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-02-07

No results posted yet for this study

Summary

Nucleus accumbens plays important roles in the process of opiate addiction and initial of relapse after detoxification.According to the single-centered preliminary open-labeled prospective trial results, the investigators hypothesize that bilateral stimulation of the NAc will effectively reduce the relapse of the opiate dependence.

Conditions

Interventions

DEVICE

Suzhou Sceneray® DBS System

We plan to use the SceneRay 1242 (SceneRay, SuZhou, China) electrode with a diameter of 1.27 mm and 4 contacts. The SceneRay 1242 electrode combined with the SceneRay 1181 implantable pulse generator has the advantage of adaptive coverage area for the Ventral Capsule/Ventral Striatum, enabling simultaneous implantation in the nucleus accumbens (NAc; 2 ventral contacts) and the anterior limb of the internal capsule (ALIC; 2 dorsal contacts) with independently programmed parameters such as frequency, amplitude, and voltage; and remote and wireless programing, which allows for convenient and prompt adjustments in emergency situations.

Sponsors & Collaborators

  • National Institute on Drug Dependence, Peking University

    collaborator UNKNOWN

  • Ruijin Hospital

    collaborator OTHER

  • West China Hospital

    collaborator OTHER

  • Nanfang Hospital, Southern Medical University

    collaborator OTHER

  • Peking University First Hospital

    collaborator OTHER

  • Tang-Du Hospital

    lead OTHER

Principal Investigators

  • Guodong Gao, M.D. · Department of neurosurgery, Tangdu Hospital

  • Lin Lu, M.D. · National Institute on Drug Dependence, Peking University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-02-06
Primary Completion
2020-01-30
Completion
2020-01-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT03424616 on ClinicalTrials.gov