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

Not Applicable

• Conditions: Addiction
• Interventions: Other: Deep brain stimulation; Other: Placebo

• Registration Number: NCT01658592
• Lead Sponsor: Guodong Gao

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-26
• Status Verified: 2012-08
• Study First Submitted QC: 2012-08-02
• Last Update Submitted: 2012-08-02
• Study First Posted: 2012-08-07
• Last Update Posted: 2012-08-07
• Primary Completion: 2014-03
• Study Completion: 2014-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo A	Deep brain stimulation	Stimulator setting is OFF
Placebo A	Placebo	Stimulator setting is OFF
NAC-VC Deep Brain Stimulation	Deep brain stimulation	The contractors located in NAc and VC are ON at the same time
NAC-VC Deep Brain Stimulation	Placebo	The contractors located in NAc and VC are ON at the same time
Placebo B	Deep brain stimulation	The contractor located in NAc is on
Placebo B	Placebo	The contractor located in NAc is on
Placebo C	Deep brain stimulation	The contactor located in VC is on
Placebo C	Placebo	The contactor located in VC is on

Primary Outcome Measures

Name	Time	Method
Reduction of Alcohol	7 months	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.

Secondary Outcome Measures

Name	Time	Method
Craving	7 months	10-point visual analog scale (VAS) of craving

Trial Locations

Locations (1)

Department of neurosurgery, Tangdu Hospital; 🇨🇳 Xi'an, Shaanxi, China