Clinical Trials Directory

Trials / Unknown

UnknownNCT03424616

Deep Brain Stimulation of Nucleus Accumbens for Opioid Relapse Prevention

Deep Brain Stimulation of Nucleus Accumbens for Opioid Relapse Prevention:A Multicenter Randomized Double-Blind Sham-stimulation Controlled Clinical Trial

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
60 (estimated)
Sponsor
Tang-Du Hospital · Academic / Other
Sex
All
Age
18 Years – 50 Years
Healthy volunteers
Not accepted

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

TypeNameDescription
DEVICESuzhou Sceneray® DBS SystemWe 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.

Timeline

Start date
2018-02-06
Primary completion
2020-01-30
Completion
2020-01-30
First posted
2018-02-07
Last updated
2018-02-07

Locations

5 sites across 1 country: China

Source: ClinicalTrials.gov record NCT03424616. Inclusion in this directory is not an endorsement.