Clinical trial NCT05786872: Efficacy and Safety of Dual-target DBS 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: UNKNOWN
Phase: NA
Conditions: Alcohol Use Disorder
Deep Brain Stimulation
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
Collaborators: name: Central South University
name: Huashan Hospital
name: Shanghai 6th People's Hospital
name: SceneRay Corporation, Limited
First posted: 2023-03-28
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 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.

Eligibility criteria: Inclusion Criteria:

* 18 to 65 years old, no limit on sex.
* Qualifies DSM-5 definition of alcohol use diagnosis, at least more than 4 terms.
* Course of alcohol use disorder ≥ 3 years.
* Tried to quit drinking (de-addiction treatment under medical conditions, quit drinking by oneself, quit drinking each time ≥ 1 week) but failed ≥ 3 times.
* 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:

* Patients who qualify DSM-5 serious mental disorder diagnosis standard (e.g. Schizophrenia spectrum, depression disorder, biphasic or related disorder, etc. )
* Patients who have other substance (tobacco excluded) abuse.
* During screening period, answered 'yes' on question 4 or 5 in suicide intention term from Columbia-Suicide Severity Rating Scale, or had significant suicide intentions 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.
* 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.
* HIV positive patients.
* Woman at pregnant or lactation period, or childbearing age woman test positive for 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.
* Patients who are participating other pharmaceutical or medical device clinical trials or have participated one in the past 3 months.
* Patients who are considered unsuitable by investigators.

Primary outcomes:
measure: Major alcohol use rate
timeFrame: 24 weeks
measure: Cumulated uncontrolled alcohol use days
timeFrame: 24 weeks
measure: Maximum consecutive alcohol suspension days
timeFrame: 24 weeks
Secondary outcomes:
measure: Alcohol use volume
timeFrame: 24 weeks
measure: Cumulated alcohol suspension days
timeFrame: 24 weeks
measure: Subjective alcohol urge
timeFrame: At 12, 20 and 32 weeks of stimulation
measure: Alcohol abstinence
timeFrame: At 12, 20 and 32 weeks of stimulation
measure: Sleep condition
timeFrame: At 12, 20 and 32 weeks of stimulation
measure: Emotion condition
timeFrame: At 12, 20 and 32 weeks of stimulation
measure: Social functions
timeFrame: At 12, 20 and 32 weeks of stimulation
Other outcomes:
measure: Brain electrophysiology study（electroencephalogram）
timeFrame: Before stimulation and parameter optimization period(1-8 weeks after stimulation)
measure: Brain electrophysiology study（Local Field Potentials）
timeFrame: Before stimulation and parameter optimization period(1-8 weeks after stimulation)
measure: PET-CT
timeFrame: Before DBS implant, after 6 months of implant.
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
Study officials:
affiliation: Shanghai Mental Health Center
name: Min Zhao
role: STUDY_CHAIR
References: