Deep Brain Stimulation of Nucleus Accumbens for Methamphetamine Addiction

Not Applicable

• Conditions: Treatment Methamphetamine Addiction
• Interventions: Procedure: Bilateral surgical implantation of DBS system to NAc

• Registration Number: NCT03347474
• Lead Sponsor: Ruijin Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-09-03
• Study Start: 2017-09-20
• Study First Submitted QC: 2017-11-15
• Study First Posted: 2017-11-20
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-24
• Last Update Posted: 2018-10-26
• Primary Completion: 2020-09-20
• Study Completion: 2020-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bilateral surgical implantation of DBS system to NAc	Bilateral surgical implantation of DBS system to NAc	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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
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
Side Effect	Baseline（preoperative）,3 months, 6 months, 12months
Change in World Health Organization Quality of Life-BREF(WHO-BREF)	Baseline（preoperative）,3 months,6 months, 12 months
Change in Fagerstrom Test of Nicotine Dependence(FTND)	Baseline（preoperative）,3 months,6 months, 12 months

Trial Locations

Locations (1)

Shanghai Ruijin Hospital Functional Neurosurgery; 🇨🇳 Shanghai, Shanghai, China