Back to resultsEfficacy and Safety of Dual-target Deep Brain Stimulation for Treatment-resistant Alcohol Use Disorder
Primary Purpose
Alcohol Use Disorder, Deep Brain Stimulation
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Dual-target deep brain stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol Use Disorder focused on measuring Alcoholism, Alcohol Drinking, Drinking Behavior, Alcohol-Related Disorders, Substance-Related Disorders, Chemically-Induced Disorders, Mental Disorders
Eligibility Criteria
Inclusion Criteria: 18 to 65 years old, no limit on sex. Meet The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for alcohol use diagnosis with more than 4 positive items. Course of alcohol use disorder ≥ 3 years. Had at least 3 failed quit drinking experiences (de-addiction treatment under medical conditions, quit drinking by oneself, quit drinking each time ≥ 1 week) 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 with other serious mental disorders (e.g. schizophrenia spectrum, depression disorder, biphasic or related disorder, etc. ) Patients who have other substance (other than tobacco) use disorders. 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. 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 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. 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.
Sites / Locations
- Second Xiangya Hospital of Central South UniversityRecruiting
- Shanghai Mental Health CenterRecruiting
- Huashan HospitalRecruiting
- Shanghai 6th People's HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dual-target deep brain stimulation
Arm Description
This is a single arm, prospective, open label clinical study, participants who fit inclusion and don't fit exclusion criteria, 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.
Outcomes
Primary Outcome Measures
Heavy 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.
Cumulated uncontrolled alcohol use days
Total days of all uncontrolled alcohol use days throughout 24 weeks
Definition: more than 3 times consecutive alcohol use (random draw) ≥ 5 standard cups
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
Cumulated uncontrolled alcohol use days: Total days of all uncontrolled alcohol use days throughout 24 weeks
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'
Secondary Outcome Measures
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.
Cumulated alcohol abstinent days
total value of 'Constant alcohol suspension' days
Subjective alcohol craving
change in alcohol urge Visual Analogue Score compared to baseline. ( 0 is no urge, 10 is extreme urge)
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).
Sleep status
Pittsburgh Sleep Quality Index score compared to baseline.
affect status
Hamilton Anxiety Scale-17 and Hamilton Depression Scale score compared to baseline.
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).
Full Information
NCT ID
NCT05884619
First Posted
May 23, 2023
Last Updated
September 8, 2023
Sponsor
Second Xiangya Hospital of Central South University
Collaborators
Shanghai Mental Health Center, Huashan Hospital, Shanghai 6th People's Hospital, SceneRay Corporation, Limited
1. Study Identification
Unique Protocol Identification Number
NCT05884619
Brief Title
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 14, 2023 (Actual)
Primary Completion Date
December 30, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Second Xiangya Hospital of Central South University
Collaborators
Shanghai Mental Health Center, Huashan Hospital, Shanghai 6th People's Hospital, SceneRay Corporation, Limited
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder, Deep Brain Stimulation
Keywords
Alcoholism, Alcohol Drinking, Drinking Behavior, Alcohol-Related Disorders, Substance-Related Disorders, Chemically-Induced Disorders, Mental Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dual-target deep brain stimulation
Arm Type
Experimental
Arm Description
This is a single arm, prospective, open label clinical study, participants who fit inclusion and don't fit exclusion criteria, 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.
Intervention Type
Device
Intervention Name(s)
Dual-target deep brain stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Heavy drinking rate
Description
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
Title
Cumulated uncontrolled alcohol use days
Description
Total days of all uncontrolled alcohol use days throughout 24 weeks
Definition: more than 3 times consecutive alcohol use (random draw) ≥ 5 standard cups
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
Cumulated uncontrolled alcohol use days: Total days of all uncontrolled alcohol use days throughout 24 weeks
Time Frame
9-32 weeks of stimulation
Title
Maximum consecutive alcohol abstinent days
Description
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
Secondary Outcome Measure Information:
Title
Alcohol use volume
Description
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
Title
Cumulated alcohol abstinent days
Description
total value of 'Constant alcohol suspension' days
Time Frame
9-32 weeks of stimulation.
Title
Subjective alcohol craving
Description
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
Title
Alcohol withdrawal scores
Description
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
Title
Sleep status
Description
Pittsburgh Sleep Quality Index score compared to baseline.
Time Frame
At 12, 20 and 32 weeks of stimulation
Title
affect status
Description
Hamilton Anxiety Scale-17 and Hamilton Depression Scale score compared to baseline.
Time Frame
At 12, 20 and 32 weeks of stimulation
Title
Social functionings
Description
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
Other Pre-specified Outcome Measures:
Title
Electrophysiology indicators
Description
Before stimulation and parameter optimization period, DBS brain electrophysiology study will be conducted, such as electroencephalogram, target Local Field Potential; Observe instant effect to participants at stimulation onset (including instant desire change, emotional change, behavioral change of experimental psychological paradigm and change in brain electrophysiological indicators etc. ), thus to provide evidence for parameter adjustment for the study).
Time Frame
Before stimulation and parameter optimization period
Title
Incidence of adverse events and related data
Description
Adverse events (AE) and device-related adverse events.
Serious adverse events (SAE) and device-related serious adverse events.
Device deficiencies and device malfunctions.
Physical examination and vital signs.
Laboratory check: blood reverse transcription (RT), prothrombin time (PT), activated partial thromboplastin time (APTT), thrombin time (TT), Fbg, liver/kidney functions, liver ultrasonic and ECG.
Imaging examination: CT or MRI.
Early drop out ratio due to adverse events.
Time Frame
Collect security data throughout the research period, including AE, SAE, etc.
Title
Positron Emission Topography imaging indicators
Description
Before DBS implant, use Positron Emission Topography (PET) to study imaging of brain metabolism, receptor and structures. Metabolism features (DA, GABA, Glu) of brain areas including DLPFC, medial prefrontal prefrontal cortex, NAcc, dorsal striatum etc. will be the focus. Patients will be retested for PET after 6 months of implant.
Time Frame
Before stimulation and parameter optimization period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 to 65 years old, no limit on sex.
Meet The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for alcohol use diagnosis with more than 4 positive items.
Course of alcohol use disorder ≥ 3 years.
Had at least 3 failed quit drinking experiences (de-addiction treatment under medical conditions, quit drinking by oneself, quit drinking each time ≥ 1 week)
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 with other serious mental disorders (e.g. schizophrenia spectrum, depression disorder, biphasic or related disorder, etc. )
Patients who have other substance (other than tobacco) use disorders.
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.
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 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.
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wei Hao
Phone
+8613907484086
Email
weihao57@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Hao
Organizational Affiliation
Second Xiangya Hospital of Central South University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Min Zhao
Organizational Affiliation
Shanghai Mental Health Center
Official's Role
Study Chair
Facility Information:
Facility Name
Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Hao
Phone
+8613907484086
Email
weihao57@163.com
First Name & Middle Initial & Last Name & Degree
Wei Hao
First Name & Middle Initial & Last Name & Degree
Mengqiang Yu
Facility Name
Shanghai Mental Health Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min Zhao
Phone
+8618017311005
Email
drminzhao@gmail.com
First Name & Middle Initial & Last Name & Degree
Min Zhao
Facility Name
Huashan Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liang Chen
Phone
+8613661882460
First Name & Middle Initial & Last Name & Degree
Liang Chen
Facility Name
Shanghai 6th People's Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200233
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wanhai Ding
Phone
+8618930170125
First Name & Middle Initial & Last Name & Degree
Wanhai Ding
12. IPD Sharing Statement
Plan to Share IPD
No
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Efficacy and Safety of Dual-target Deep Brain Stimulation for Treatment-resistant Alcohol Use Disorder
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