NCT03952455

Deep Brain Stimulation of the Bilateral Nucleus Accumbens for Patients With Methadone Maintenance Treatment

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Methadone maintenance treatment (MMT) is one of the main forms of treatments for opioid dependence. Despite its effectiveness and widespread use, people will experience withdrawal if daily dose is insufficient or missed, promoting reluctance to attempt detoxification. In addition, methadone is a full opioid agonist which can induce respiratory depression or sedation without ceiling level, so overdose usage can be fatal. Hence, an alternative therapy is needed to completely reduce the carving for drugs and to relieve the negative affective sate caused by withdrawal. Deep brain stimulation (DBS) is a reasonable treatment approach for addiction. Since 2009 the first case report emerged, the nucleus accumbens (NAc) is still the only brain target to be investigated in clinical case series of DBS for alcohol and heroin addiction. This research will mainly investigate the effectiveness and safety of NAc-DBS for patients with methadone maintenance treatment. The investigators will also explore the influence of NAc-DBS on brain activity and cognition.

Conditions

• Addiction Opiate

Interventions

Type	Name	Description
PROCEDURE	Bilateral surgical implantation of DBS system to Nucleus Accumbens	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. The contact length is 3.0 mm and the spacings between the ventral and dorsal contacts are 2 mm, 4 mm, and 4 mm, respectively, spanning a total length of 22.5 mm (3 + 2 + 3 + 4 + 3 + 4 + 3 mm, with 0.5 mm projecting from the electrode tip).

Timeline

• Start date: 2019-05-13
• Primary completion: 2021-06-01
• Completion: 2021-06-01
• First posted: 2019-05-16
• Last updated: 2020-01-10

Locations

1 site across 1 country: China