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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
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.
Second Xiangya Hospital of Central South University
Changsha, Hunan, China
RECRUITINGShanghai Mental Health Center
Shanghai, Shanghai Municipality, China
RECRUITINGHuashan Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGHeavy 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.
Time frame: 9-32 weeks of stimulation
Cumulated uncontrolled alcohol use days
Total days of all uncontrolled alcohol use days throughout 24 weeks 1. Definition: more than 3 times consecutive alcohol use (random draw) ≥ 5 standard cups 2. One time uncontrolled alcohol use days: e.g. 3 times consecutive follow-up results ≥ 5 standard cups, fourth time \< 5 standard cups, then uncontrolled alcohol use days is 3 \* 3 = 9 days 3. Cumulated uncontrolled alcohol use days: Total days of all uncontrolled alcohol use days throughout 24 weeks
Time frame: 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'
Time frame: 9-32 weeks of stimulation
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.
Time frame: 9-32 weeks after stimulation
Cumulated alcohol abstinent days
total value of 'Constant alcohol suspension' days
Time frame: 9-32 weeks of stimulation.
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Shanghai 6th People's Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGSubjective alcohol craving
change in alcohol urge Visual Analogue Score compared to baseline. ( 0 is no urge, 10 is extreme urge)
Time frame: 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).
Time frame: At 12, 20 and 32 weeks of stimulation
Sleep status
Pittsburgh Sleep Quality Index score compared to baseline.
Time frame: At 12, 20 and 32 weeks of stimulation
affect status
Hamilton Anxiety Scale-17 and Hamilton Depression Scale score compared to baseline.
Time frame: 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).
Time frame: At 12, 20 and 32 weeks of stimulation