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Novel Deep Brain Stimulation in Ventral Capsule/Ventral Striatum for Methamphetamine Addiction

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ClinicalTrials.gov Identifier: NCT03347474
Recruitment Status : Recruiting
First Posted : November 20, 2017
Last Update Posted : February 28, 2018
Information provided by (Responsible Party):
Bomin Sun, Ruijin Hospital

Brief Summary:
The main objective of this study is to assess the efficacy of bilateral deep brain stimulation (DBS) of the ventral capsule/ventral striatum (VC/VS) as a novel treatment in severe methamphetamine addiction. Our hypothesis is that bilateral DBS of the VC/VS will significantly reduce the craving for methamphetamine.

Condition or disease Intervention/treatment
Treatment Methamphetamine Addiction Procedure: Bilateral surgical implantation of DBS system to VC/ VS

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Intervention Model: Single Group Assignment
Intervention Model Description: All subjects will receive bilateral surgical implantation of DBS system
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Novel Deep Brain Stimulation in Ventral Capsule/Ventral Striatum for Methamphetamine Addiction: A Pilot Study
Actual Study Start Date : September 20, 2017
Estimated Primary Completion Date : September 20, 2018
Estimated Study Completion Date : December 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Methamphetamine
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Bilateral surgical implantation of DBS system to VC/ VS
Device:Suzhou Sceneray® DBS system
Procedure: Bilateral surgical implantation of DBS system to VC/ VS
The SceneRay DBS device utilized in the present study is a double-channel device designed and manufactured by Suzhou Scene-Ray Medical Co., Ltd. The DBS system includes a dual-channel neurostimulator kit, lead kit, extension kit, clinician-operated wireless programmer, test stimulator, and patient controller. The lead (diameter =1.27 mm) contains four stimulating contacts made of platinumiridium alloy. The length of each contact is 1.5 mm, and interval spaces are 0.5 mm. This device shares the same basic principles utilized by Medtronic products, with unique wireless programming and electrode fixing designs. The amplitude (0-10 V), pulse width (60-960 ms), and frequency (1-1,600 Hz) can be programmed, and different frequencies may be utilized in the left and right hemispheres using this type of dual-channel IPG.

Primary Outcome Measures :
  1. 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.

  2. change in Addiction Severity Index(ASI) [ Time Frame: Baseline(preoperative),6 months,12 months ]

Secondary Outcome Measures :
  1. Change in the Hamilton Anxiety Scale [ Time Frame: Baseline(preoperative),3 months, 6 months, 12months ]
  2. Change in the Hamilton Depression Scale [ Time Frame: Baseline(preoperative),3 months, 6 months, 12 months ]
  3. Change in the Quality of Life Assessment (SF-36) [ Time Frame: Baseline(preoperative),3 months, 6 months, 12 months ]
  4. Change in World Health Organization Quality of Life-BREF(WHO-BREF) [ Time Frame: Baseline(preoperative),3 months,6 months, 12 months ]
  5. Chang in Pittsburgh Sleep Quality Index [ Time Frame: Baseline(preoperative),3 months,6 months, 12 months ]
  6. Neuropsychological measures(Scores of cogstate battery) [ Time Frame: Baseline(preoperative),6 months,12 months ]
  7. The Structured Clinical Interview for DSM-IV Axis II(SCID-II) [ Time Frame: Baseline(preoperative),6 months,12 months ]
  8. Change in Fagerstrom Test of Nicotine Dependence(FTND) [ Time Frame: Baseline(preoperative),3 months,6 months, 12 months ]

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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:

  • Severe suicidal tendency;
  • 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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03347474

Contact: Chencheng Zhang, MD +086-18217122884 i@cczhang.org

China, Shanghai
Shanghai Ruijin Hospital Functional Neurosurgery Recruiting
Shanghai, Shanghai, China, 200025
Contact: Chencheng Zhang, MD    +086-18217122884    i@cczhang.org   
Contact: Yingying Zhang, MSc    +086-17602137369    zhyy019@126.com   
Sponsors and Collaborators
Ruijin Hospital

Responsible Party: Bomin Sun, Director of the Department of Functional Neurosurgery, Ruijin Hospital
ClinicalTrials.gov Identifier: NCT03347474     History of Changes
Other Study ID Numbers: DBS Methamphetamine
First Posted: November 20, 2017    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bomin Sun, Ruijin Hospital:
Bilateral Ventral Capsule/ Ventral Striatum
Methamphetamine Addiction

Additional relevant MeSH terms:
Behavior, Addictive
Compulsive Behavior
Impulsive Behavior
Central Nervous System Stimulants
Physiological Effects of Drugs
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors