Deep Brain Stimulation of Nucleus Accumbens for Methamphetamine Addiction

Study Overview
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Brief Summary
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The main objective of this study is to assess the efficacy of bilateral deep brain stimulation (DBS) of the Nucleus Accumbens(NAc) as a novel treatment in severe methamphetamine addiction. Our hypothesis is that bilateral DBS of the NAc will significantly reduce the craving for methamphetamine.

Official Title
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Deep Brain Stimulation of Nucleus Accumbens for Methamphetamine Addiction

Conditions
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Treatment Methamphetamine Addiction

Intervention / Treatment
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* Procedure: Bilateral surgical implantation of DBS system to NAc


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: DSM-IV-TR diagnosis of Drug addiction disorder; Age 18-65 years old; Proficiency in Mandarin language; Failure to detox more than three times; Capacity to provide informed consent (understanding of the study purpose and methods); Exclusion Criteria: Multidrug abuse and formation of addiction; Serious and unstable organic diseases (e.g. unstable coronal heart disease); Any history of seizure disorder or hemorrhagic stroke; 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); HIV positive; Pregnancy and/or lactation;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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
Intervention Model: Single Group Assignment
Interventional Model Description: All subjects will receive bilateral surgical implantation of DBS system
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bilateral surgical implantation of DBS system to NAc<br> | Procedure: Bilateral surgical implantation of DBS system to NAc<br>* The Medtronic, PINS and SceneRay DBS device will be utilized in the present study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in 10-point visual analog scale of carving | The score of scale is from 0 to 10. 0 represents no carving for drug, 10 means the greatest degree of carving for drug. | Baseline (preoperative),3 months,6 months, 12 months | 
| change in Obsessive Compulsive Drug Use Scale |  | Baseline (preoperative),3 months,6 months, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side Effect |  | Baseline（preoperative）,3 months, 6 months, 12months | 
| Change in the Hamilton Anxiety Scale |  | Baseline（preoperative）,3 months, 6 months, 12months | 
| Change in the Hamilton Depression Scale |  | Baseline（preoperative）,3 months, 6 months, 12 months | 
| Change in the Quality of Life Assessment (SF-36) |  | Baseline（preoperative）,3 months, 6 months, 12 months | 
| Change in World Health Organization Quality of Life-BREF(WHO-BREF) |  | Baseline（preoperative）,3 months,6 months, 12 months | 
| Chang in Pittsburgh Sleep Quality Index |  | Baseline（preoperative）,3 months,6 months, 12 months | 
| Neuropsychological measures(Scores of cognitive battery) |  | Baseline（preoperative）,6 months,12 months | 
| Change in Fagerstrom Test of Nicotine Dependence(FTND) |  | Baseline（preoperative）,3 months,6 months, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bilateral Nucleus Accumbens, Methamphetamine Addiction