Efficacy and Safety of Dual-target DBS for Treatment-resistant Alcohol Use Disorder

Shanghai Mental Health Center

Status: Enrolling

Conditions: Deep Brain Stimulation; Alcohol Use Disorder

Treatments: Device: dual-target deep brain stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05786872

MZhao-012

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

12 participants in 1 patient group

dual-target deep brain stimulation

Experimental group

Description:

This is a single arm, prospective, open label clinical study, participants who fit inclusion/exclusion standards, 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.

Treatment:

Device: dual-target deep brain stimulation