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

This study is currently recruiting participants.
Verified August 2012 by Tang-Du Hospital
Sponsor:
Collaborator:
Tang-Du Hospital
Information provided by (Responsible Party):
Guodong Gao, Tang-Du Hospital
ClinicalTrials.gov Identifier:
NCT01658592
First received: July 26, 2012
Last updated: August 2, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention
Addiction
Other: Deep brain stimulation
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Deep Brain Stimulation of the Nucleus Accumbens and the Ventral Anterior Internal Capsule as a Novel Treatment in Severe Alcohol Addiction

Resource links provided by NLM:


Further study details as provided by Tang-Du Hospital:

Primary Outcome Measures:
  • Reduction of Alcohol [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]
    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:
  • Craving [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]
    10-point visual analog scale (VAS) of craving


Other Outcome Measures:
  • Psychological components [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]
    Addiction severity(ASI); Psychological components (Anxiety (BAI-21 item); Depression (BDI-21 item); Quality of life (WHOQL-Brief); Health condition(SF-36).


Estimated Enrollment: 20
Study Start Date: July 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01658592

Contacts
Contact: Gao G Dong, Doctor +86 29-84777435 gguodong@fmmu.edu.cn
Contact: Wang X Lian, Doctor +86 29-84777284 tdwxlian@126.com

Locations
China, Shaanxi
Department of neurosurgery, Tangdu Hospital Recruiting
Xi'an, Shaanxi, China, 710038
Contact: Gao G Dong, Doctor    +86 29-84777435    gguodong@fmmu.edu.cn   
Contact: Wang X Lian, Doctor    +86 29-84777284    tdwxlian@126.com   
Sub-Investigator: Wang X Lian, Doctor         
Sponsors and Collaborators
Guodong Gao
Tang-Du Hospital
Investigators
Principal Investigator: Gao G Dong, Doctor Department of neurosurgery, Tangdu Hospital
  More Information

No publications provided

Responsible Party: Guodong Gao, Neurosurgery Department, Tang-Du Hospital
ClinicalTrials.gov Identifier: NCT01658592     History of Changes
Other Study ID Numbers: NAc-VC DBS for alcohol addict
Study First Received: July 26, 2012
Last Updated: August 2, 2012
Health Authority: China: Ministry of Health

Keywords provided by Tang-Du Hospital:
Alcohol Addiction;
Deep Brain Stimulation;
Nucleus Accumbens;
Ventral Anterior Internal capsule;

Additional relevant MeSH terms:
Alcoholism
Behavior, Addictive
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Compulsive Behavior
Impulsive Behavior

ClinicalTrials.gov processed this record on April 15, 2014