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
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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UNKNOWN
NA
20 participants
INTERVENTIONAL
2012-07-31
2014-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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NAC-VC Deep Brain Stimulation
The contractors located in NAc and VC are ON at the same time
Deep brain stimulation
Stimulator setting is ON
Placebo
Stimulator setting is OFF
Placebo A
Stimulator setting is OFF
Deep brain stimulation
Stimulator setting is ON
Placebo
Stimulator setting is OFF
Placebo B
The contractor located in NAc is on
Deep brain stimulation
Stimulator setting is ON
Placebo
Stimulator setting is OFF
Placebo C
The contactor located in VC is on
Deep brain stimulation
Stimulator setting is ON
Placebo
Stimulator setting is OFF
Interventions
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Deep brain stimulation
Stimulator setting is ON
Placebo
Stimulator setting is OFF
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
50 Years
ALL
No
Sponsors
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Tang-Du Hospital
OTHER
Guodong Gao
OTHER
Responsible Party
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Guodong Gao
Neurosurgery Department
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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NAc-VC DBS for alcohol addict
Identifier Type: -
Identifier Source: org_study_id
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