Clinical trial NCT05884619: Efficacy and Safety of Dual-target Deep Brain Stimulation for Treatment-resistant Alcohol Use Disorder
Official title: Efficacy and Safety of Dual-target Deep Brain Stimulation for Treatment-resistant Alcohol Use Disorder: a Multi-center, Single Arm, Prospective, Open-label, Extendable Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcohol Use Disorder
Deep Brain Stimulation
Keywords: Alcoholism
Alcohol Drinking
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Lead sponsor: Second Xiangya Hospital of Central South University
Sponsor class: OTHER
Collaborators: name: Shanghai Mental Health Center
name: Huashan Hospital
name: Shanghai 6th People's Hospital
name: SceneRay Corporation, Limited
First posted: 2023-06-01
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. 18 to 65 years old, no limit on sex.
2. Meet The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for alcohol use diagnosis with more than 4 positive items.
3. Course of alcohol use disorder ≥ 3 years.
4. Had at least 3 failed quit drinking experiences (de-addiction treatment under medical conditions, quit drinking by oneself, quit drinking each time ≥ 1 week)
5. Patient and relatives agree to accept systemic treatment of this study and sign Informed Consent Form after study purpose, content, expected treatment and risk etc. are fully explained and understood.

Exclusion Criteria:

1. Patients with other serious mental disorders (e.g. schizophrenia spectrum, depression disorder, biphasic or related disorder, etc. )
2. Patients who have other substance (other than tobacco) use disorders.
3. During screening period, answered 'yes' on question 4 or 5 in suicide intention term from Columbia-Suicide Severity Rating Scale, or had significant suicidal ideations in the past 3 months, or patients who are considered by researchers to have suicide or violence risks.
4. Patients who have serious or unstable cardiovascular, respiratory, liver, kidney, hematological, endocrine, nervous system or other systemic diseases.
5. Patients who have implanted cochlear, pacemaker, cardiac defibrillator, single-sided or double-sided products of the same category, or the investigator evaluates patients have done surgeries within 6 months that can affect this study.
6. HIV positive patients.
7. Woman at pregnant or lactation period, or childbearing age woman test positive for human chorionic gonadotropin (HCG)/urine pregnancy check; or patients who can't take effective contraception measures during trial; or patients who plan to be/make pregnant 3 months after the trial starts.
8. Patients who are participating other pharmaceutical or medical device clinical trials or have participated one in the past 3 months.
9. Patients who are considered unsuitable by investigators.

Primary outcomes:
measure: Heavy drinking rate
timeFrame: 9-32 weeks of stimulation
measure: Cumulated uncontrolled alcohol use days
timeFrame: 9-32 weeks of stimulation
measure: Maximum consecutive alcohol abstinent days
timeFrame: 9-32 weeks of stimulation
Secondary outcomes:
measure: Alcohol use volume
timeFrame: 9-32 weeks after stimulation
measure: Cumulated alcohol abstinent days
timeFrame: 9-32 weeks of stimulation.
measure: Subjective alcohol craving
timeFrame: At 12, 20 and 32 weeks of stimulation
measure: Alcohol withdrawal scores
timeFrame: At 12, 20 and 32 weeks of stimulation
measure: Sleep status
timeFrame: At 12, 20 and 32 weeks of stimulation
measure: affect status
timeFrame: At 12, 20 and 32 weeks of stimulation
measure: Social functionings
timeFrame: At 12, 20 and 32 weeks of stimulation
Other outcomes:
measure: Electrophysiology indicators
timeFrame: Before stimulation and parameter optimization period
measure: Incidence of adverse events and related data
timeFrame: Collect security data throughout the research period, including AE, SAE, etc.
measure: Positron Emission Topography imaging indicators
timeFrame: Before stimulation and parameter optimization period
Locations:
city: Changsha
country: China
facility: Second Xiangya Hospital of Central South University
state: Hunan
city: Shanghai
country: China
facility: Shanghai Mental Health Center
state: Shanghai
city: Shanghai
country: China
facility: Huashan Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai 6th People's Hospital
state: Shanghai
Study officials:
affiliation: Second Xiangya Hospital of Central South University
name: Wei Hao
role: STUDY_CHAIR
affiliation: Shanghai Mental Health Center
name: Min Zhao
role: STUDY_CHAIR
References: