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

NCT ID: NCT01658592

Last Updated: 2012-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2014-03-31

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.

Conditions

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Addiction

Keywords

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Alcohol Addiction; Deep Brain Stimulation; Nucleus Accumbens; Ventral Anterior Internal capsule;

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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NAC-VC Deep Brain Stimulation

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

Group Type EXPERIMENTAL

Deep brain stimulation

Intervention Type OTHER

Stimulator setting is ON

Placebo

Intervention Type OTHER

Stimulator setting is OFF

Placebo A

Stimulator setting is OFF

Group Type SHAM_COMPARATOR

Deep brain stimulation

Intervention Type OTHER

Stimulator setting is ON

Placebo

Intervention Type OTHER

Stimulator setting is OFF

Placebo B

The contractor located in NAc is on

Group Type EXPERIMENTAL

Deep brain stimulation

Intervention Type OTHER

Stimulator setting is ON

Placebo

Intervention Type OTHER

Stimulator setting is OFF

Placebo C

The contactor located in VC is on

Group Type EXPERIMENTAL

Deep brain stimulation

Intervention Type OTHER

Stimulator setting is ON

Placebo

Intervention Type OTHER

Stimulator setting is OFF

Interventions

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Deep brain stimulation

Stimulator setting is ON

Intervention Type OTHER

Placebo

Stimulator setting is OFF

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tang-Du Hospital

OTHER

Sponsor Role collaborator

Guodong Gao

OTHER

Sponsor Role lead

Responsible Party

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Guodong Gao

Neurosurgery Department

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Gao G Dong, Doctor

Role: PRINCIPAL_INVESTIGATOR

Department of neurosurgery, Tangdu Hospital

Locations

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Department of neurosurgery, Tangdu Hospital

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Gao G Dong, Doctor

Role: CONTACT

Phone: +86 29-84777435

Email: [email protected]

Wang X Lian, Doctor

Role: CONTACT

Phone: +86 29-84777284

Email: [email protected]

Facility Contacts

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Gao G Dong, Doctor

Role: primary

Wang X Lian, Doctor

Role: backup

Other Identifiers

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NAc-VC DBS for alcohol addict

Identifier Type: -

Identifier Source: org_study_id