Back to resultsDeep Brain Stimulation of Nucleus Accumbens for Methamphetamine Addiction
Primary Purpose
Treatment Methamphetamine Addiction
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Bilateral surgical implantation of DBS system to NAc
Sponsored by
About this trial
This is an interventional treatment trial for Treatment Methamphetamine Addiction focused on measuring Bilateral Nucleus Accumbens, Methamphetamine Addiction
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;
Sites / Locations
- Shanghai Ruijin Hospital Functional NeurosurgeryRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Bilateral surgical implantation of DBS system to NAc
Arm Description
Outcomes
Primary Outcome Measures
change in 10-point visual analog scale of carving
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
Secondary Outcome Measures
Side Effect
Change in the Hamilton Anxiety Scale
Change in the Hamilton Depression Scale
Change in the Quality of Life Assessment (SF-36)
Change in World Health Organization Quality of Life-BREF(WHO-BREF)
Chang in Pittsburgh Sleep Quality Index
Neuropsychological measures(Scores of cognitive battery)
Change in Fagerstrom Test of Nicotine Dependence(FTND)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03347474
Brief Title
Deep Brain Stimulation of Nucleus Accumbens for Methamphetamine Addiction
Official Title
Deep Brain Stimulation of Nucleus Accumbens for Methamphetamine Addiction
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 20, 2017 (Actual)
Primary Completion Date
September 20, 2020 (Anticipated)
Study Completion Date
December 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruijin Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment Methamphetamine Addiction
Keywords
Bilateral Nucleus Accumbens, Methamphetamine Addiction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All subjects will receive bilateral surgical implantation of DBS system
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bilateral surgical implantation of DBS system to NAc
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Bilateral surgical implantation of DBS system to NAc
Intervention Description
The Medtronic, PINS and SceneRay DBS device will be utilized in the present study.
Primary Outcome Measure Information:
Title
change in 10-point visual analog scale of carving
Description
The score of scale is from 0 to 10. 0 represents no carving for drug, 10 means the greatest degree of carving for drug.
Time Frame
Baseline (preoperative),3 months,6 months, 12 months
Title
change in Obsessive Compulsive Drug Use Scale
Time Frame
Baseline (preoperative),3 months,6 months, 12 months
Secondary Outcome Measure Information:
Title
Side Effect
Time Frame
Baseline（preoperative）,3 months, 6 months, 12months
Title
Change in the Hamilton Anxiety Scale
Time Frame
Baseline（preoperative）,3 months, 6 months, 12months
Title
Change in the Hamilton Depression Scale
Time Frame
Baseline（preoperative）,3 months, 6 months, 12 months
Title
Change in the Quality of Life Assessment (SF-36)
Time Frame
Baseline（preoperative）,3 months, 6 months, 12 months
Title
Change in World Health Organization Quality of Life-BREF(WHO-BREF)
Time Frame
Baseline（preoperative）,3 months,6 months, 12 months
Title
Chang in Pittsburgh Sleep Quality Index
Time Frame
Baseline（preoperative）,3 months,6 months, 12 months
Title
Neuropsychological measures(Scores of cognitive battery)
Time Frame
Baseline（preoperative）,6 months,12 months
Title
Change in Fagerstrom Test of Nicotine Dependence(FTND)
Time Frame
Baseline（preoperative）,3 months,6 months, 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chencheng Zhang, MD
Phone
+086-18217122884
Email
i@cczhang.org
Facility Information:
Facility Name
Shanghai Ruijin Hospital Functional Neurosurgery
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chencheng Zhang, MD
Phone
+086-18217122884
Email
i@cczhang.org
First Name & Middle Initial & Last Name & Degree
Yingying Zhang, MSc
Phone
+086-17602137369
Email
zhyy019@126.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
23337942
Citation
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.
Results Reference
background
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Deep Brain Stimulation of Nucleus Accumbens for Methamphetamine Addiction
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