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| Name | Class |
|---|---|
| Shanghai Mental Health Center | OTHER |
| Huashan Hospital | OTHER |
| Shanghai 6th People's Hospital | OTHER |
| SceneRay Corporation, Limited |
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This is a multi-center, single arm, prospective, open-label, extendable study for the efficacy and safety of dual-target deep brain stimulation for treatment-resistant alcohol use disorder.
Total of 12 subjects from two centers ( Shanghai Mental Health Center and The Second Xiangya Hospital of Central South University ) who meet inclusion and don't meet exclusion criteria are recruited to undergo neurosurgical implantation of dual-target DBS in bilateral nucleus accumbens (NAcc) and anterior limb of internal capsule (ALIC) on Day 0. The DBS system will be turned on for stimulation and parameter adjustment will be conducted on day 10-14 after implantation. The efficacy and safety evaluation will be conducted in 9-32 weeks after implantation. The indicators on efficacy are heaving drinking rate, uncontrolled alcohol consumption days, maximum consecutive alcohol abstinent days. The indicators for safety are adverse events (AE) and device related AE, serious adverse events (SAE) and device related SAE, device deficiencies (DD) and device malfunction, physical examination and vital signs, laboratory examination, ECG, imaging examination, scale evaluation and early drop out ratio due to AE.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dual-target deep brain stimulation | Experimental | This is a single arm, prospective, open label clinical study, participants who fit inclusion and don't fit exclusion criteria, completed physical anti-addiction treatments and surgical implantation standard will start DBS system stimulation and adjust parameters after 10-14 days of implantation. Then after stimulation for 9-32 weeks, they will be evaluated for treatment efficacies. This study is extendable, with agreements from participants, long term efficacy and safety follow-up study will be performed after 32 weeks ± 7 days of following, once every 2-3 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dual-target deep brain stimulation | Device | DBS electrodes will be implanted into the ALIC and the NAcc, electric stimulation of those areas are used to treat alcohol use disorder and to evaluate the efficacy and safety of DBS system. |
| Measure | Description | Time Frame |
|---|---|---|
| Heavy drinking rate | Calculation formula: 'major alcohol use' times / 56 (total observation times) * 100%; a) Marked as maximum days of 'Constant alcohol suspension' b) Note: i. Major alcohol use standard: Blow test positive and reported ≥ 5 standard cups daily over the past 3 days. 1 standard cup = 10g of pure alcohol. | 9-32 weeks of stimulation |
| Cumulated uncontrolled alcohol use days | Total days of all uncontrolled alcohol use days throughout 24 weeks
| 9-32 weeks of stimulation |
| Maximum consecutive alcohol abstinent days | Constant alcohol suspension standard: Blow test negative and no alcohol use reported over past 3 days. Marked as maximum days of 'Constant alcohol suspension' | 9-32 weeks of stimulation |
| Measure | Description | Time Frame |
|---|---|---|
| Alcohol use volume | change in monthly average alcohol use volume compared to baseline. (Record in every follow-up according to participants. Record alcohol type, amount and experience when drinking throughout 9-32 weeks after stimulation. Increased value implies worse result and reduce of alcohol use volume indicates improvement. | 9-32 weeks after stimulation |
| Measure | Description | Time Frame |
|---|---|---|
| Electrophysiology indicators | Before stimulation and parameter optimization period, DBS brain electrophysiology study will be conducted, such as electroencephalogram, target Local Field Potential; Observe instant effect to participants at stimulation onset (including instant desire change, emotional change, behavioral change of experimental psychological paradigm and change in brain electrophysiological indicators etc. ), thus to provide evidence for parameter adjustment for the study). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei Hao | Contact | +8613907484086 | weihao57@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Wei Hao | Second Xiangya Hospital of Central South University | Study Chair |
| Min Zhao | Shanghai Mental Health Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Second Xiangya Hospital of Central South University | Recruiting | Changsha | Hunan | 410011 | China |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D000428 | Alcohol Drinking |
| D004327 | Drinking Behavior |
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| INDUSTRY |
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| Cumulated alcohol abstinent days | total value of 'Constant alcohol suspension' days | 9-32 weeks of stimulation. |
| Subjective alcohol craving | change in alcohol urge Visual Analogue Score compared to baseline. ( 0 is no urge, 10 is extreme urge) | At 12, 20 and 32 weeks of stimulation |
| Alcohol withdrawal scores | change in Clinical Institute Withdrawal Assessment for Alcohol Scale (CIWA-Ar) score compared to baseline. Minimum score is 0, maximum score is 67, higher the score, alcohol withdrawal is more severe (worse outcome). | At 12, 20 and 32 weeks of stimulation |
| Sleep status | Pittsburgh Sleep Quality Index score compared to baseline. | At 12, 20 and 32 weeks of stimulation |
| affect status | Hamilton Anxiety Scale-17 and Hamilton Depression Scale score compared to baseline. | At 12, 20 and 32 weeks of stimulation |
| Social functionings | Substance Dependence Severity Scale (SDSS) score compared to baseline. Minimum score is 0, maximum score is 20, higher the score, substance dependence is more severe (worse outcome). | At 12, 20 and 32 weeks of stimulation |
| Before stimulation and parameter optimization period |
| Incidence of adverse events and related data |
| Collect security data throughout the research period, including AE, SAE, etc. |
| Positron Emission Topography imaging indicators | Before DBS implant, use Positron Emission Topography (PET) to study imaging of brain metabolism, receptor and structures. Metabolism features (DA, GABA, Glu) of brain areas including DLPFC, medial prefrontal prefrontal cortex, NAcc, dorsal striatum etc. will be the focus. Patients will be retested for PET after 6 months of implant. | Before stimulation and parameter optimization period |
| Shanghai Mental Health Center | Recruiting | Shanghai | Shanghai Municipality | 200030 | China |
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| Huashan Hospital | Recruiting | Shanghai | Shanghai Municipality | 200040 | China |
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| Shanghai 6th People's Hospital | Recruiting | Shanghai | Shanghai Municipality | 200233 | China |
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