The Effectiveness of Deep Brain Stimulation for Opioid Relapse Prevention
NCT ID: NCT02440152
Last Updated: 2017-06-29
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
PHASE2/PHASE3
6 participants
INTERVENTIONAL
2017-02-01
2021-07-31
Brief Summary
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The investigators hypothesise that bilateral stimulation of the NAcc will significantly reduce withdrawal symptoms and thus enable the patients to substantially decrease their Levomethadone usage.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Deep brain stimulation
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. The contact length is 3.0 mm and the spacings between the ventral and dorsal contacts are 2 mm, 4 mm, and 4 mm, respectively, spanning a total length of 22.5 mm (3 + 2 + 3 + 4 + 3 + 4 + 3 mm, with 0.5 mm projecting from the electrode tip).
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. The contact length is 3.0 mm and the spacings between the ventral and dorsal contacts are 2 mm, 4 mm, and 4 mm, respectively, spanning a total length of 22.5 mm (3 + 2 + 3 + 4 + 3 + 4 + 3 mm, with 0.5 mm projecting from the electrode tip).
Eligibility Criteria
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Inclusion Criteria
* Long lasting heroin addiction (determined by diagnostic-criteria in Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition)
* Duration longer than 6 months
* A lack of response to long-term treatment
* Capacity to provide informed consent (understanding of the study purpose and methods)
* Substitution methadone treatment at a constant dose within three months prior to inclusion.
Exclusion Criteria
* 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)
* Serious and unstable organic diseases (e.g. unstable coronal heart disease)
* HIV positive
* Pregnancy and/or lactation
18 Years
60 Years
ALL
No
Sponsors
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Suzhou Sceneray Medical Co. , Ltd
INDUSTRY
Shanghai Mental Health Center
OTHER
Institution of Neuroscience
UNKNOWN
National Natural Science Foundation of China
OTHER_GOV
Ruijin Hospital
OTHER
Responsible Party
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Bomin Sun
Department of Functional Neurosurgery
Principal Investigators
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Bomin Sun, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Ruijin Hospital
Locations
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Shanghai RuiJin Hospital Psychitric Department
Shanghai, Shanghai Municipality, China
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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Luigjes J, van den Brink W, Feenstra M, van den Munckhof P, Schuurman PR, Schippers R, Mazaheri A, De Vries TJ, Denys D. Deep brain stimulation in addiction: a review of potential brain targets. Mol Psychiatry. 2012 Jun;17(6):572-83. doi: 10.1038/mp.2011.114. Epub 2011 Sep 20.
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.
Valencia-Alfonso CE, Luigjes J, Smolders R, Cohen MX, Levar N, Mazaheri A, van den Munckhof P, Schuurman PR, van den Brink W, Denys D. Effective deep brain stimulation in heroin addiction: a case report with complementary intracranial electroencephalogram. Biol Psychiatry. 2012 Apr 15;71(8):e35-7. doi: 10.1016/j.biopsych.2011.12.013. Epub 2012 Jan 26. No abstract available.
Zhou H, Xu J, Jiang J. Deep brain stimulation of nucleus accumbens on heroin-seeking behaviors: a case report. Biol Psychiatry. 2011 Jun 1;69(11):e41-2. doi: 10.1016/j.biopsych.2011.02.012. Epub 2011 Apr 13. No abstract available.
Other Identifiers
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2014-15
Identifier Type: -
Identifier Source: org_study_id
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