Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Tang-Du Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NAC-VC Deep Brain Stimulation | Experimental | The contractors located in NAc and VC are ON at the same time |
|
| Placebo A | Sham Comparator | Stimulator setting is OFF |
|
| Placebo B | Experimental | The contractor located in NAc is on |
|
| Placebo C | Experimental | The contactor located in VC is on |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deep brain stimulation | Other | Stimulator setting is ON |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Craving | 10-point visual analog scale (VAS) of craving | 7 months |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gao G Dong, Doctor | Contact | +86 29-84777435 | gguodong@fmmu.edu.cn | |
| Wang X Lian, Doctor | Contact | +86 29-84777284 | tdwxlian@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Gao G Dong, Doctor | Department of neurosurgery, Tangdu Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of neurosurgery, Tangdu Hospital | Recruiting | Xi'an | Shaanxi | 710038 | China |
Not provided
| ID | Term |
|---|---|
| D016739 | Behavior, Addictive |
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D003192 | Compulsive Behavior |
| D007175 | Impulsive Behavior |
| D001519 | Behavior |
| D019973 | Alcohol-Related Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D046690 | Deep Brain Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Other | Stimulator setting is OFF |
|
| D019966 |
| Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |