The Effectiveness of Deep Brain Stimulation for Opioid Relapse Prevention

Study Overview
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Brief Summary
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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.

Official Title
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The Effectiveness of Deep Brain Stimulation for Opioid Relapse Prevention

Conditions
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Opiate Addiction

Intervention / Treatment
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* Device: Suzhou Sceneray® DBS System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Deep brain stimulation<br> | Device: Suzhou Sceneray® DBS System<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weekly urine tests |  | Baseline (preoperative), 3 months, 6 months, 9 months, 12 months, 18 months, 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 10-point visual analog scale (VAS) craving score for opioid drugs |  | Baseline (preoperative), 3 months, 6 months, 9 months, 12 months, 18 months, 24 months | 
| Change in Hamilton Anxiety Scale |  | Baseline (preoperative), 3 months, 6 months, 9 months, 12 months, 18 months, 24 months | 
| Change in Hamilton Depression Scale-17 |  | Baseline (preoperative), 3 months, 6 months, 9 months, 12 months, 18 months, 24 months | 
| Change in SF-36 assessment |  | Baseline (preoperative), 6 months, 12 month, 24 month | 
| Neuropsychological measures（Scores of Iowa gambling task and Model task） |  | Baseline (preoperative), Intraoperative,6 months,12month,24month |