An interventional study of Deep brain stimulation and Placebo in Addiction, sponsored by Guodong Gao. Status unknown at 1 site in China. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2012-08-07.
Sponsored by Guodong Gao · Not applicable, Interventional, and Treatment
The main objective of this study is to assess the efficacy of bilateral deep brain stimulation (DBS) of the nucleus accumbens (NAc) and the ventral anterior internal capsule (VC) as a novel treatment in severe alcohol addiction. The included patients have been treated so far with drugs that inhibits alcohol, or psychological behavior training.
Our hypothesis is that bilateral NAc-VC DBS will significantly reduce the craving for alcohol and thus enable the patients to decrease their alcohol intake substantially.
The nucleus accumbens (NAc) is considered associating with addiction. The ventral anterior internal capsule(VC) is proved a effective target to obsessive compulsive disorder(OCD). Like other addiction behaviors most alcohol addicts contain obsessive compulsive symptom. We explored an operation method, that is, in the Leksell stereotactic positioning system take VC as the point of entry, take NAc as the point of target, then make sure that the distance between entry and target points are included in the four contacts of electrode of DBS. When stimulator is ON the investigators can adjust parameters so that the coverage of electrode contains both Vc and NAc. The investigators suppose that bilateral NAc-VC DBS will significantly reduce the craving for alcohol and thus enable the patients to decrease their alcohol intake substantially.
1,606 studies on the registry are indexed under Alcoholism; 329 are open to participants now.
This study's planned enrollment of 20 is below the median of 87 across 1,371 interventional studies indexed under Alcoholism.
Browse Alcoholism studies →This is the only study on the registry with Guodong Gao as lead sponsor.
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Exclusion Criteria:
The contractors located in NAc and VC are ON at the same time
Other: Deep brain stimulation · Other: Placebo
Stimulator setting is OFF
Other: Deep brain stimulation · Other: Placebo
The contractor located in NAc is on
Other: Deep brain stimulation · Other: Placebo
The contactor located in VC is on
Other: Deep brain stimulation · Other: Placebo
Stimulator setting is ON
Stimulator setting is OFF
Reduction of Alcohol
Reduction of the dosage of alcohol(all kinds of liquor were converted into pure alcohol) comparing baseline and the particular ward rounds during and at the end of the crossover-design.
Time frame: 7 months
Craving
10-point visual analog scale (VAS) of craving
Time frame: 7 months
Psychological components
Addiction severity(ASI); Psychological components (Anxiety (BAI-21 item); Depression (BDI-21 item); Quality of life (WHOQL-Brief); Health condition(SF-36).
Time frame: 7 months
This study is status unknown, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.
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