The Effectiveness of Deep Brain Stimulation for Opioid Relapse Prevention

Ruijin Hospital6 enrolled

Overview

The nucleus accumbens (NAcc) has a significant role in the process of opiate addiction and the initiation of relapse after detoxification. There is evidence that deep brain stimulation (DBS) of the NAcc exerts a positive effect on individuals with severe heroin addiction via inhibitory action . The investigators hypothesise that bilateral stimulation of the NAcc will significantly reduce withdrawal symptoms and thus enable the patients to substantially decrease their Levomethadone usage.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Opiate Addiction

Interventions

Suzhou Sceneray® DBS SystemDEVICE

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).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Proficiency in Mandarin language * Long lasting heroin addiction (determined by diagnostic-criteria in Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition) * Duration longer than 6 months * A lack of response to long-term treatment * Capacity to provide informed consent (understanding of the study purpose and methods) * Substitution methadone treatment at a constant dose within three months prior to inclusion. Exclusion Criteria: * Clinical relevant psychiatric comorbidity (schizophrenic psychoses, bipolar affective diseases with psychotic symptoms)(MINI 6.0) * Past stereotactic neurosurgical intervention * Neurological disease (Abnormal PET-CT, MRI, EEG) * Contraindications of MRI-examination, e.g. implanted cardiac pacemaker/ heart defibrillator * Contraindications of stereotactic intervention, e.g. increased bleeding-disposition, cerebrovascular diseases (e.g. arteriovenous malfunction, aneurysms, systemic vascular diseases) * Serious and unstable organic diseases (e.g. unstable coronal heart disease) * HIV positive * Pregnancy and/or lactation

Locations (2)

Shanghai RuiJin Hospital Psychitric Department

Shanghai, Shanghai Municipality, China

RECRUITING

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China

RECRUITING

Outcomes

Primary Outcomes

Weekly urine tests

Time frame: Baseline (preoperative), 3 months, 6 months, 9 months, 12 months, 18 months, 24 months

Secondary Outcomes

Change in 10-point visual analog scale (VAS) craving score for opioid drugs

Time frame: Baseline (preoperative), 3 months, 6 months, 9 months, 12 months, 18 months, 24 months

Change in Hamilton Anxiety Scale

Time frame: Baseline (preoperative), 3 months, 6 months, 9 months, 12 months, 18 months, 24 months

Change in Hamilton Depression Scale-17

Time frame: Baseline (preoperative), 3 months, 6 months, 9 months, 12 months, 18 months, 24 months

Change in SF-36 assessment

Time frame: Baseline (preoperative), 6 months, 12 month, 24 month

Neuropsychological measures（Scores of Iowa gambling task and Model task）

Time frame: Baseline (preoperative), Intraoperative,6 months,12month,24month

Central Contacts

ChenCheng Zhang, MD

CONTACT

i@cczhang.org

Kristina Zeljic, MSc

CONTACT

zeljickristina@ion.ac.cn

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.