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

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

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.

Study Overview

• Status: Unknown
• Conditions: Addiction
• Intervention / Treatment: Other: Deep brain stimulation; Other: Placebo

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gao G Dong, Doctor; Phone Number: +86 29-84777435; Email: gguodong@fmmu.edu.cn
• Study Contact Backup: Name: Wang X Lian, Doctor; Phone Number: +86 29-84777284; Email: tdwxlian@126.com

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710038
      • Recruiting
      • Department of neurosurgery, Tangdu Hospital
      • Contact: Gao G Dong, Doctor; Phone Number: +86 29-84777435; Email: gguodong@fmmu.edu.cn
      • Contact: Wang X Lian, Doctor; Phone Number: +86 29-84777284; Email: tdwxlian@126.com
      • Sub-Investigator: Wang X Lian, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psychological components	Addiction severity(ASI); Psychological components (Anxiety (BAI-21 item); Depression (BDI-21 item); Quality of life (WHOQL-Brief); Health condition(SF-36).	7 months

Collaborators and Investigators

• Sponsor: Guodong Gao
• Collaborators: Tang-Du Hospital
• Investigators: Principal Investigator: Gao G Dong, Doctor, Department of neurosurgery, Tangdu Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Anticipated): March 1, 2014
• Study Completion (Anticipated): March 1, 2014

Study Registration Dates

• First Submitted: July 26, 2012
• First Submitted That Met QC Criteria: August 2, 2012
• First Posted (Estimate): August 7, 2012

Study Record Updates

• Last Update Posted (Estimate): August 7, 2012
• Last Update Submitted That Met QC Criteria: August 2, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: Alcohol Addiction;; Deep Brain Stimulation;; Nucleus Accumbens;; Ventral Anterior Internal capsule
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Compulsive Behavior; Impulsive Behavior; Alcoholism; Behavior, Addictive
• Other Study ID Numbers: NAc-VC DBS for alcohol addict