Deep Brain Stimulation of the Nucleus Accumbens and the Ventral Anterior Internal Capsule for Severe Alcohol Addiction

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Deep Brain Stimulation of the Nucleus Accumbens and the Ventral Anterior Internal Capsule as a Novel Treatment in Severe Alcohol Addiction

Conditions
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Addiction

Intervention / Treatment
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* Other: Deep brain stimulation
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years Long lasting alcohol addiction (fulfilled diagnostic-criteria according to DSM-IV,ICD-10) At least one detoxication-treatment without a long-term period of abstinence has already taken place Long-term inpatient treatment to support abstinence have occurred Free patient's decision / Informed Consent (existing comprehensive ability in meaning, methodology and execution of the study and ability of acceptance) If prior medication, stable dosage of psychopharmacological drugs over the last three months, which shall, after checking be retained during the study Exclusion Criteria: Hospitalization for psychotic symptoms Clinical relevant psychiatric comorbidity (such as schizophrenic psychoses, bipolar affective diseases, severe personality disorder, and so on. And diagnosed by criteria according to DSM-IV,ICD-10) Contraindications of a MRI-examination, e.g. implanted cardiac pacemaker/ heart defibrillator Current and in the last six months existent paranoid-hallucinated symptomatology Foreign aggressiveness in the last six months Verbal IQ < 85 (evaluated with the Wechsler Adult Intelligence Scale- Chinese Revised (WAIS-CR) Stereotactic respectively neurosurgical intervention in the past Other neurological diseases 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NAC-VC Deep Brain Stimulation<br>The contractors located in NAc and VC are ON at the same time | Other: Deep brain stimulation<br>* Stimulator setting is ON<br>Other: Placebo<br>* Stimulator setting is OFF<br>|
| Sham Comparator: Placebo A<br>Stimulator setting is OFF | Other: Deep brain stimulation<br>* Stimulator setting is ON<br>Other: Placebo<br>* Stimulator setting is OFF<br>|
| Experimental: Placebo B<br>The contractor located in NAc is on | Other: Deep brain stimulation<br>* Stimulator setting is ON<br>Other: Placebo<br>* Stimulator setting is OFF<br>|
| Experimental: Placebo C<br>The contactor located in VC is on | Other: Deep brain stimulation<br>* Stimulator setting is ON<br>Other: Placebo<br>* Stimulator setting is OFF<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Craving | 10-point visual analog scale (VAS) of craving | 7 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alcohol Addiction;, Deep Brain Stimulation;, Nucleus Accumbens;, Ventral Anterior Internal capsule;