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 fit inclusion and exclusion criteria are recruited to undergo neurosurgical implantation of dual-target Deep Brain Stimulation (DBS) in bilateral nucleus accumbens (NAcc) and anterior limb of internal capsule (ALIC) on a certain date, the DBS system will be turned on for stimulation and parameters adjusted 10-14 days after implantation, treatment purposes are evaluated after DBS system has been turned on for 9-32 weeks. Primary efficacy is evaluated by major alcohol consumption rate, uncontrolled alcohol consumption days, maximum consecutive alcohol suspension days. Safety is evaluated by 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, imageological 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
RECRUITINGMajor alcohol use rate
Calculation formula: 'major alcohol use' times / 56 (total observation times) \* 100%
Time frame: 24 weeks
Cumulated uncontrolled alcohol use days
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: 24 weeks
Maximum consecutive alcohol suspension days
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. ii. Minor alcohol use standard: No matter blow test is positive or not, alcohol use is reported over past 3 days but less than 5 standard cups. iii. Constant alcohol suspension standard: Blow test negative and no alcohol use reported over past 3 days.
Time frame: 24 weeks
Alcohol use volume
9-32 weeks after stimulation, 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: 24 weeks
Cumulated alcohol suspension days
total value of 'Constant alcohol suspension' days after 9-32 weeks of stimulation.
Time frame: 24 weeks
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Subjective alcohol urge
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 abstinence
Change in CIWA-Ar score compared to baseline.
Time frame: At 12, 20 and 32 weeks of stimulation
Sleep condition
Pittsburgh Sleep Quality Index score compared to baseline.
Time frame: At 12, 20 and 32 weeks of stimulation
Emotion condition
Hamilton Anxiety Scale-17 and Hamilton Depression Scale score compared to baseline.
Time frame: At 12, 20 and 32 weeks of stimulation
Social functions
SDSS score compared to baseline.
Time frame: At 12, 20 and 32 weeks of stimulation