Deep Brain Stimulation of Nucleus Accumbens for Opioid Relapse Prevention
NCT ID: NCT03424616
Last Updated: 2018-02-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2018-02-06
2020-01-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Postoperative immediate Deep brain stimulation
The addicts undergone the deep brain stimulation while the stimulation (Suzhou Sceneray® DBS System) was turned on 1-2 weeks postoperatively.
Suzhou Sceneray® DBS System
We plan to use the SceneRay 1242 (SceneRay, SuZhou, China) electrode with a diameter of 1.27 mm and 4 contacts. The SceneRay 1242 electrode combined with the SceneRay 1181 implantable pulse generator has the advantage of adaptive coverage area for the Ventral Capsule/Ventral Striatum, enabling simultaneous implantation in the nucleus accumbens (NAc; 2 ventral contacts) and the anterior limb of the internal capsule (ALIC; 2 dorsal contacts) with independently programmed parameters such as frequency, amplitude, and voltage; and remote and wireless programing, which allows for convenient and prompt adjustments in emergency situations.
Postoperative delayed Deep brain stimulation
The addicts undergone the deep brain stimulation while the stimulation (Suzhou Sceneray® DBS System) was off until 25 months postoperatively, during which the following up was kept, then the the stimulation was turned on 25 months postoperatively.
Suzhou Sceneray® DBS System
We plan to use the SceneRay 1242 (SceneRay, SuZhou, China) electrode with a diameter of 1.27 mm and 4 contacts. The SceneRay 1242 electrode combined with the SceneRay 1181 implantable pulse generator has the advantage of adaptive coverage area for the Ventral Capsule/Ventral Striatum, enabling simultaneous implantation in the nucleus accumbens (NAc; 2 ventral contacts) and the anterior limb of the internal capsule (ALIC; 2 dorsal contacts) with independently programmed parameters such as frequency, amplitude, and voltage; and remote and wireless programing, which allows for convenient and prompt adjustments in emergency situations.
Interventions
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Suzhou Sceneray® DBS System
We plan to use the SceneRay 1242 (SceneRay, SuZhou, China) electrode with a diameter of 1.27 mm and 4 contacts. The SceneRay 1242 electrode combined with the SceneRay 1181 implantable pulse generator has the advantage of adaptive coverage area for the Ventral Capsule/Ventral Striatum, enabling simultaneous implantation in the nucleus accumbens (NAc; 2 ventral contacts) and the anterior limb of the internal capsule (ALIC; 2 dorsal contacts) with independently programmed parameters such as frequency, amplitude, and voltage; and remote and wireless programing, which allows for convenient and prompt adjustments in emergency situations.
Eligibility Criteria
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Inclusion Criteria
* Moderate to severe opiates abuse disorders (fulfilled diagnostic-criteria according to DSM-5)
1. History of opiates abuse no less than 3 years
2. Failure of at least three addiction treatments ( in hospital or compulsive rehabilitation）, among which failure of methadone maintenance treatment must be met
3. completion of detoxification ( Negative urine test for morphine, methamphetamine, ketamine and buprenorphine)
* Free patient's decision/informed Consent (existing comprehensive ability in meaning, methodology and execution of the study and ability of acceptance, known the benefit and risk of the treatment)
Exclusion Criteria
* Contraindications of a MRI-examination, e.g. implanted cardiac pacemaker/heart defibrillator
* Abuse of other type of drugs
* severe cognitive impairments
* Enrollment in other clinical trials
* Stereotactic respectively neurosurgical intervention in the past
* Contraindications of a stereotactic operation, e.g. increased bleeding-disposition, cerebrovascular diseases (e.g. arteriovenous malfunction, aneurysms, systemic vascular diseases)
* Serious and instable organic diseases (e.g. instable coronal heart disease)
* tested positively for HIV
* pregnancy and/or lactation
* Severe disorders for coagulation and liver function
* Epilepsy or other severe brain trauma or neurological impairments
18 Years
50 Years
ALL
No
Sponsors
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National Institute on Drug Dependence, Peking University
UNKNOWN
Ruijin Hospital
OTHER
West China Hospital
OTHER
Nanfang Hospital, Southern Medical University
OTHER
Peking University First Hospital
OTHER
Tang-Du Hospital
OTHER
Responsible Party
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Principal Investigators
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Guodong Gao, M.D.
Role: PRINCIPAL_INVESTIGATOR
Department of neurosurgery, Tangdu Hospital
Lin Lu, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Institute on Drug Dependence, Peking University
Locations
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National Institute on Drug Dependence, Peking University
Beijing, Beijing Municipality, China
Nanfang Hospital Southern Medical University
Guangzhou, Guangdong, China
Department of neurosurgery, Tangdu Hospital
Xi'an, Shaanxi, China
Ruijin Hospital
Shanghai, Shanghai Municipality, China
West China Hospital
Chengdu, Sichuan, China
Countries
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Central Contacts
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Facility Contacts
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Jie Shi, M.D.
Role: backup
Kaijun Yang, M.D.
Role: primary
Wei Wang, M.D.
Role: primary
References
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Qu L, Ge S, Li N, Wang W, Yang K, Wu P, Wang X, Shi J. Clinical evaluation of deep brain stimulation of nucleus accumbens/anterior limb of internal capsule for opioid relapse prevention: protocol of a multicentre, prospective and double-blinded study. BMJ Open. 2019 Feb 13;9(2):e023516. doi: 10.1136/bmjopen-2018-023516.
Other Identifiers
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NAcDBSORP
Identifier Type: -
Identifier Source: org_study_id
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