- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03347474
Deep Brain Stimulation of Nucleus Accumbens for Methamphetamine Addiction
October 24, 2018 updated by: Bomin Sun, Ruijin Hospital
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 Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200025
- Recruiting
- Shanghai Ruijin Hospital Functional Neurosurgery
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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;
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Bilateral surgical implantation of DBS system to NAc
|
The Medtronic, PINS and SceneRay DBS device will be utilized in the present study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline (preoperative),3 months,6 months, 12 months
|
change in Obsessive Compulsive Drug Use Scale
Time Frame: Baseline (preoperative),3 months,6 months, 12 months
|
Baseline (preoperative),3 months,6 months, 12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Side Effect
Time Frame: Baseline(preoperative),3 months, 6 months, 12months
|
Baseline(preoperative),3 months, 6 months, 12months
|
Change in the Hamilton Anxiety Scale
Time Frame: Baseline(preoperative),3 months, 6 months, 12months
|
Baseline(preoperative),3 months, 6 months, 12months
|
Change in the Hamilton Depression Scale
Time Frame: Baseline(preoperative),3 months, 6 months, 12 months
|
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
|
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
|
Baseline(preoperative),3 months,6 months, 12 months
|
Chang in Pittsburgh Sleep Quality Index
Time Frame: Baseline(preoperative),3 months,6 months, 12 months
|
Baseline(preoperative),3 months,6 months, 12 months
|
Neuropsychological measures(Scores of cognitive battery)
Time Frame: Baseline(preoperative),6 months,12 months
|
Baseline(preoperative),6 months,12 months
|
Change in Fagerstrom Test of Nicotine Dependence(FTND)
Time Frame: Baseline(preoperative),3 months,6 months, 12 months
|
Baseline(preoperative),3 months,6 months, 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 20, 2017
Primary Completion (ANTICIPATED)
September 20, 2020
Study Completion (ANTICIPATED)
December 30, 2020
Study Registration Dates
First Submitted
September 3, 2017
First Submitted That Met QC Criteria
November 15, 2017
First Posted (ACTUAL)
November 20, 2017
Study Record Updates
Last Update Posted (ACTUAL)
October 26, 2018
Last Update Submitted That Met QC Criteria
October 24, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-10-25 DBS-NAc Meth
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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