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| Name | Class |
|---|---|
| Suzhou Sceneray Medical Co. , Ltd | INDUSTRY |
| Shanghai Mental Health Center | OTHER |
| Institution of Neuroscience | UNKNOWN |
| National Natural Science Foundation of China |
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The nucleus accumbens (NAcc) has a significant role in the process of opiate addiction and the initiation of relapse after detoxification. There is evidence that deep brain stimulation (DBS) of the NAcc exerts a positive effect on individuals with severe heroin addiction via inhibitory action .
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Deep brain stimulation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Suzhou Sceneray® DBS System | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Weekly urine tests | Baseline (preoperative), 3 months, 6 months, 9 months, 12 months, 18 months, 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 10-point visual analog scale (VAS) craving score for opioid drugs | Baseline (preoperative), 3 months, 6 months, 9 months, 12 months, 18 months, 24 months | |
| Change in Hamilton Anxiety Scale | Baseline (preoperative), 3 months, 6 months, 9 months, 12 months, 18 months, 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ChenCheng Zhang, MD | Contact | i@cczhang.org | ||
| Kristina Zeljic, MSc | Contact | zeljickristina@ion.ac.cn |
| Name | Affiliation | Role |
|---|---|---|
| Bomin Sun, MD, PhD | Ruijin Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai RuiJin Hospital Psychitric Department | Recruiting | Shanghai | Shanghai Municipality | 200025 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21931318 | Background | 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. | |
| 23337942 | Result | 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. |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| OTHER_GOV |
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|
| Change in Hamilton Depression Scale-17 | Baseline (preoperative), 3 months, 6 months, 9 months, 12 months, 18 months, 24 months |
| Change in SF-36 assessment | Baseline (preoperative), 6 months, 12 month, 24 month |
| Neuropsychological measures（Scores of Iowa gambling task and Model task） | Baseline (preoperative), Intraoperative,6 months,12month,24month |
| Shanghai Mental Health Center | Recruiting | Shanghai | Shanghai Municipality | 200030 | China |
|
| 22281120 | Result | 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. |
| 21489407 | Result | 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. |