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Deep Brain Stimulation of Nucleus Accumbens for Methamphetamine Addiction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03347474
Recruitment Status : Unknown
Verified October 2018 by Bomin Sun, Ruijin Hospital.
Recruitment status was:  Recruiting
First Posted : November 20, 2017
Last Update Posted : October 26, 2018
Sponsor:
Information provided by (Responsible Party):
Bomin Sun, Ruijin Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Treatment Methamphetamine Addiction Procedure: Bilateral surgical implantation of DBS system to NAc Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
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: Deep Brain Stimulation of Nucleus Accumbens for Methamphetamine Addiction
Actual Study Start Date : September 20, 2017
Estimated Primary Completion Date : September 20, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Methamphetamine

Arms and Interventions
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Arm Intervention/treatment
Experimental: Bilateral surgical implantation of DBS system to NAc Procedure: Bilateral surgical implantation of DBS system to NAc
The Medtronic, PINS and SceneRay DBS device will be utilized in the present study.


Outcome Measures
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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 Obsessive Compulsive Drug Use Scale [ Time Frame: Baseline (preoperative),3 months,6 months, 12 months ]

Secondary Outcome Measures :
  1. Side Effect [ Time Frame: Baseline（preoperative）,3 months, 6 months, 12months ]
  2. Change in the Hamilton Anxiety Scale [ Time Frame: Baseline（preoperative）,3 months, 6 months, 12months ]
  3. Change in the Hamilton Depression Scale [ Time Frame: Baseline（preoperative）,3 months, 6 months, 12 months ]
  4. Change in the Quality of Life Assessment (SF-36) [ Time Frame: Baseline（preoperative）,3 months, 6 months, 12 months ]
  5. Change in World Health Organization Quality of Life-BREF(WHO-BREF) [ Time Frame: Baseline（preoperative）,3 months,6 months, 12 months ]
  6. Chang in Pittsburgh Sleep Quality Index [ Time Frame: Baseline（preoperative）,3 months,6 months, 12 months ]
  7. Neuropsychological measures(Scores of cognitive battery) [ 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;
Contacts and Locations
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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


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

Locations
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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
More Information
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Publications:

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Responsible Party: Bomin Sun, Director of the Department of Functional Neurosurgery, Ruijin Hospital
ClinicalTrials.gov Identifier: NCT03347474    
Other Study ID Numbers: 2018-10-25 DBS-NAc Meth
First Posted: November 20, 2017    Key Record Dates
Last Update Posted: October 26, 2018
Last Verified: October 2018

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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 Nucleus Accumbens
Methamphetamine Addiction
Additional relevant MeSH terms:
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Behavior, Addictive
Compulsive Behavior
Impulsive Behavior