Deep Brain Stimulation of Nucleus Accumbens for Methamphetamine Addiction

Ruijin Hospital1 site in 1 country10 target enrollmentSeptember 20, 2017

ConditionsTreatment Methamphetamine Addiction

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Treatment Methamphetamine Addiction
Sponsor: Ruijin Hospital
Enrollment: 10
Locations: 1
Primary Endpoint: change in 10-point visual analog scale of carving
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 20, 2017

End Date

December 30, 2020

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Ruijin Hospital

Responsible Party

Principal Investigator

Bomin Sun

Director of the Department of Functional Neurosurgery

Ruijin Hospital

Eligibility Criteria

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;

Outcomes

Primary Outcomes

change in 10-point visual analog scale of carving

Time Frame: 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

Time Frame: Baseline (preoperative),3 months,6 months, 12 months

Secondary Outcomes

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)