Deep Brain Stimulation of Nucleus Accumbens for Methamphetamine Addiction

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 20, 2020

Interventions

  • Procedure: Bilateral surgical implantation of DBS system to NAc
    • The Medtronic, PINS and SceneRay DBS device will be utilized in the present study.

Arms, Groups and Cohorts

  • Experimental: Bilateral surgical implantation of DBS system to NAc

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

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

Participating in This Clinical Trial

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;

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ruijin Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Bomin Sun, Director of the Department of Functional Neurosurgery – Ruijin Hospital
  • Overall Contact(s)
    • Chencheng Zhang, MD, +086-18217122884, i@cczhang.org

References

Kuhn J, Moller M, Treppmann JF, Bartsch C, Lenartz D, Gruendler TO, Maarouf M, Brosig A, Barnikol UB, Klosterkotter J, Sturm V. Deep brain stimulation of the nucleus accumbens and its usefulness in severe opioid addiction. Mol Psychiatry. 2014 Feb;19(2):145-6. doi: 10.1038/mp.2012.196. Epub 2013 Jan 22. No abstract available.

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