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

Primary Purpose

Addiction

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Deep brain stimulation
Placebo
Sponsored by
Guodong Gao
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Addiction focused on measuring Alcohol Addiction;, Deep Brain Stimulation;, Nucleus Accumbens;, Ventral Anterior Internal capsule;

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of neurosurgery, Tangdu HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Sham Comparator

Experimental

Experimental

Arm Label

NAC-VC Deep Brain Stimulation

Placebo A

Placebo B

Placebo C

Arm Description

The contractors located in NAc and VC are ON at the same time

Stimulator setting is OFF

The contractor located in NAc is on

The contactor located in VC is on

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Craving
10-point visual analog scale (VAS) of craving

Full Information

First Posted
July 26, 2012
Last Updated
August 2, 2012
Sponsor
Guodong Gao
Collaborators
Tang-Du Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01658592
Brief Title
Deep Brain Stimulation of the Nucleus Accumbens and the Ventral Anterior Internal Capsule for Severe Alcohol Addiction
Official Title
Deep Brain Stimulation of the Nucleus Accumbens and the Ventral Anterior Internal Capsule as a Novel Treatment in Severe Alcohol Addiction
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Unknown status
Study Start Date
July 2012 (undefined)
Primary Completion Date
March 2014 (Anticipated)
Study Completion Date
March 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Guodong Gao
Collaborators
Tang-Du Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Addiction
Keywords
Alcohol Addiction;, Deep Brain Stimulation;, Nucleus Accumbens;, Ventral Anterior Internal capsule;

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NAC-VC Deep Brain Stimulation
Arm Type
Experimental
Arm Description
The contractors located in NAc and VC are ON at the same time
Arm Title
Placebo A
Arm Type
Sham Comparator
Arm Description
Stimulator setting is OFF
Arm Title
Placebo B
Arm Type
Experimental
Arm Description
The contractor located in NAc is on
Arm Title
Placebo C
Arm Type
Experimental
Arm Description
The contactor located in VC is on
Intervention Type
Other
Intervention Name(s)
Deep brain stimulation
Intervention Description
Stimulator setting is ON
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Stimulator setting is OFF
Primary Outcome Measure Information:
Title
Reduction of Alcohol
Description
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
Secondary Outcome Measure Information:
Title
Craving
Description
10-point visual analog scale (VAS) of craving
Time Frame
7 months
Other Pre-specified Outcome Measures:
Title
Psychological components
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gao G Dong, Doctor
Phone
+86 29-84777435
Email
gguodong@fmmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Wang X Lian, Doctor
Phone
+86 29-84777284
Email
tdwxlian@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gao G Dong, Doctor
Organizational Affiliation
Department of neurosurgery, Tangdu Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of neurosurgery, Tangdu Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710038
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gao G Dong, Doctor
Phone
+86 29-84777435
Email
gguodong@fmmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Wang X Lian, Doctor
Phone
+86 29-84777284
Email
tdwxlian@126.com
First Name & Middle Initial & Last Name & Degree
Wang X Lian, Doctor

12. IPD Sharing Statement

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

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