4006-776-356 出国就医服务电话

免费获得国外相关药品，最快 1 个工作日回馈药物信息

出境医 / 临床实验 / The Effect of rTMS to the Prefrontal Cortex in Alcohol Use Disorder (MAGNA)

The Effect of rTMS to the Prefrontal Cortex in Alcohol Use Disorder (MAGNA)

Study Description
Brief Summary:
The goal of this study is to investigate a treatment approach for alcohol use disorder (AUD) using a novel form of brain stimulation called deep repetitive transcranial magnetic stimulation (rTMS). The investigators will be targeting frontal regions of the brain that are important for memory and decision making. These brain regions have been shown to be impaired in patients with AUD. Previous studies have mostly used rTMS to a different frontal brain region that is not as deep. These studies have shown that rTMS can reduce craving for alcohol, but there is a lack of research showing that rTMS impacts alcohol consumption.

Condition or disease Intervention/treatment Phase
Alcohol Use Disorder Device: active rTMS Behavioral: Inpatient admission Device: sham rTMS Not Applicable

Detailed Description:
This study aims to examine the effect of rTMS on alcohol drinking behavior in an observed laboratory setting. Participants with AUD will be recruited and admitted to the inpatient unit for the whole study. After a brief detoxification period, they will receive 3 weeks of rTMS while in the research unit. Before and after the 3 weeks of stimulation, participants will participate in a decision-making experiment where they can choose to have an alcoholic drink or the equivalent amount of money that the drink would cost (alcohol self-administration sessions). The investigators will examine their response to alcohol, as well as their performance on tasks that relate to impulsivity and memory. Participants will also undergo an MRI scan (with spectroscopy) before and after the stimulation period to look at changes in the medial prefrontal cortex of the brain. Participants will then meet with a study physician for 6 weeks after the study for assessments of alcohol use and medical management sessions.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: active vs. sham stimulation
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: double-blind
Primary Purpose: Treatment
Official Title: The Effect of rTMS to the Prefrontal Cortex in Alcohol Use Disorder
Actual Study Start Date : June 24, 2019
Estimated Primary Completion Date : December 30, 2022
Estimated Study Completion Date : December 30, 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: Active Stimulation
Participants will be receiving active rTMS.
 Device: active rTMS
rTMS delivers magnetic stimulation to the brain by using an electromagnet to generate a current that can penetrate the scalp and skull.

Behavioral: Inpatient admission
All subjects will be admitted to the hospital for a brief detoxification period followed by 3 weeks of abstinence.
Sham Comparator: Sham Stimulation
Participants will be receiving sham stimulation with a smaller coil housed within the rTMS device.
 Behavioral: Inpatient admission
All subjects will be admitted to the hospital for a brief detoxification period followed by 3 weeks of abstinence.

Device: sham rTMS
The sham coil setting is designed to mimic the auditory artifact and the scalp sensations evoked by the real coil, and to produce activation of facial muscles similar to the effect of a real H coil, without stimulating the brain itself.
Outcome Measures
Primary Outcome Measures :
  1. Change in the choice to self-administer alcohol in the laboratory as assessed by counting the number of drinks consumed in the 2-hour laboratory session. [ Time Frame: 4 weeks ]
    Participants will participate in alcohol self-administration sessions in which they are presented with the choice of alcohol or money. The investigators will study the change in choices to choose alcohol during these sessions. There will be one session prior to rTMS and one after 3 weeks of rTMS.

  2. Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0. [ Time Frame: 10 weeks ]
    Adverse events will be assessed in recorded in accordance with CTCAE v4.0.


Secondary Outcome Measures :
  1. Change in craving for alcohol measured using the Alcohol Urge Questionnaire (AUQ). [ Time Frame: 4 weeks ]
    This AUQ (Bohn et al. 1995) is an 8-item self report questionnaire where participants rate a seven-point Likert scale with responses ranging from "strongly disagree" to "strongly agree", and a total score is derived from the sum of these items following reverse scoring of two items. A lower score is a better outcome which represents less desire to drink. Scores range from 8-56.

  2. Change in GABA in the mPFC and ACC as measured with magnetic resonance spectroscopy (MRS). [ Time Frame: 4 weeks ]
    MRS is performed by using an MRI machine to study metabolites and neurotransmitters in the brain.

  3. Change in abstinence from alcohol following discharge assessed with the Time Line Follow Back Interview. [ Time Frame: 10 weeks ]
  4. Changes in cognitive control as measured by using the Frontal Assessment Battery (FAB). [ Time Frame: 4 weeks ]
    The FAB is a brief tool that discriminates between frontal-temporal type cognitive issues from from Alzheimer's type memory issues. Higher scores are better and scores range from 0-18.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   22 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Current moderate to severe alcohol use disorder, per DSM-5
  2. Use of alcohol which parallels or exceeds the amount alcohol that will be administered in this study (1 drinking episode per week raising BAL to 0.03 g/dl - approximately 2 drinks within an hour).
  3. Age 22-55
  4. Able to give informed consent, and comply with study procedures
  5. Medically healthy, with the absence of current or past medical or neurological illnesses (including glaucoma, increased intracranial pressure, liver disease, cardiac disease, or seizure disorders)

Exclusion Criteria:

  1. Has a contraindication to MRI, such as magnetically reactive implants, which includes metal in head except in mouth (cochlear implant, implanted brain stimulators, aneurysm clips), cardiac pacemakers, implanted neurostimulators and medication pumps, and intracardiac lines.
  2. Substance use disorder with substances other than alcohol or nicotine. The current use of sedative-hypnotics or opiates will be exclusionary
  3. Meets DSM-5 criteria for other psychiatric illness, such as major depression, that would interfere with participation.
  4. History of seizures of any type
  5. A family history of epilepsy
  6. Taking psychotropic medication that would affect resting motor threshold (such as anticonvulsants) or increase risk of seizure (especially tricyclic antidepressants of neuroleptics)
  7. Current suicide risk or a history of suicide attempt within the past 2 years
  8. Have unstable physical disorders, including those that are previously undiagnosed, untreated, inadequately treated, or active to an extent which might make participation hazardous. For example, hypertension (a resting blood pressure > 140/90), heart failure, a recent history of myocardial infarction, previous stroke, brain lesions, any history of seizures under any circumstances or low hemoglobin.
  9. Currently pregnant
  10. History of severe alcohol withdrawal requiring medical care, such as withdrawal seizures, delirium tremens, withdrawal necessitating medical detoxification.
  11. A desire to pursue standard treatment for AUD, such as a rehabilitation program or FDA approved medications for AUD
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Jonathan Wai, MD 646-774-7654 jonathan.wai@nyspi.columbia.edu

Locations
Layout table for location information
United States, New York
New York State Psychiatric Institute Recruiting
New York, New York, United States, 10032
Contact: Jonathan Wai         
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
Layout table for investigator information
Principal Investigator: Jonathan Wai New York State Psychiatric Institute
Tracking Information
First Submitted Date  ICMJE January 9, 2019
First Posted Date  ICMJE January 18, 2019
Last Update Posted Date May 24, 2021
Actual Study Start Date  ICMJE June 24, 2019
Estimated Primary Completion Date December 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 15, 2019)
  • Change in the choice to self-administer alcohol in the laboratory as assessed by counting the number of drinks consumed in the 2-hour laboratory session. [ Time Frame: 4 weeks ]
    Participants will participate in alcohol self-administration sessions in which they are presented with the choice of alcohol or money. The investigators will study the change in choices to choose alcohol during these sessions. There will be one session prior to rTMS and one after 3 weeks of rTMS.
  • Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0. [ Time Frame: 10 weeks ]
    Adverse events will be assessed in recorded in accordance with CTCAE v4.0.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2019)
  • Change in craving for alcohol measured using the Alcohol Urge Questionnaire (AUQ). [ Time Frame: 4 weeks ]
    This AUQ (Bohn et al. 1995) is an 8-item self report questionnaire where participants rate a seven-point Likert scale with responses ranging from "strongly disagree" to "strongly agree", and a total score is derived from the sum of these items following reverse scoring of two items. A lower score is a better outcome which represents less desire to drink. Scores range from 8-56.
  • Change in GABA in the mPFC and ACC as measured with magnetic resonance spectroscopy (MRS). [ Time Frame: 4 weeks ]
    MRS is performed by using an MRI machine to study metabolites and neurotransmitters in the brain.
  • Change in abstinence from alcohol following discharge assessed with the Time Line Follow Back Interview. [ Time Frame: 10 weeks ]
  • Changes in cognitive control as measured by using the Frontal Assessment Battery (FAB). [ Time Frame: 4 weeks ]
    The FAB is a brief tool that discriminates between frontal-temporal type cognitive issues from from Alzheimer's type memory issues. Higher scores are better and scores range from 0-18.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of rTMS to the Prefrontal Cortex in Alcohol Use Disorder
Official Title  ICMJE The Effect of rTMS to the Prefrontal Cortex in Alcohol Use Disorder
Brief Summary The goal of this study is to investigate a treatment approach for alcohol use disorder (AUD) using a novel form of brain stimulation called deep repetitive transcranial magnetic stimulation (rTMS). The investigators will be targeting frontal regions of the brain that are important for memory and decision making. These brain regions have been shown to be impaired in patients with AUD. Previous studies have mostly used rTMS to a different frontal brain region that is not as deep. These studies have shown that rTMS can reduce craving for alcohol, but there is a lack of research showing that rTMS impacts alcohol consumption.
Detailed Description This study aims to examine the effect of rTMS on alcohol drinking behavior in an observed laboratory setting. Participants with AUD will be recruited and admitted to the inpatient unit for the whole study. After a brief detoxification period, they will receive 3 weeks of rTMS while in the research unit. Before and after the 3 weeks of stimulation, participants will participate in a decision-making experiment where they can choose to have an alcoholic drink or the equivalent amount of money that the drink would cost (alcohol self-administration sessions). The investigators will examine their response to alcohol, as well as their performance on tasks that relate to impulsivity and memory. Participants will also undergo an MRI scan (with spectroscopy) before and after the stimulation period to look at changes in the medial prefrontal cortex of the brain. Participants will then meet with a study physician for 6 weeks after the study for assessments of alcohol use and medical management sessions.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
active vs. sham stimulation
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description:
double-blind
Primary Purpose: Treatment
Condition  ICMJE Alcohol Use Disorder
Intervention  ICMJE
  • Device: active rTMS
    rTMS delivers magnetic stimulation to the brain by using an electromagnet to generate a current that can penetrate the scalp and skull.
  • Behavioral: Inpatient admission
    All subjects will be admitted to the hospital for a brief detoxification period followed by 3 weeks of abstinence.
  • Device: sham rTMS
    The sham coil setting is designed to mimic the auditory artifact and the scalp sensations evoked by the real coil, and to produce activation of facial muscles similar to the effect of a real H coil, without stimulating the brain itself.
Study Arms  ICMJE
  • Experimental: Active Stimulation
    Participants will be receiving active rTMS.
    Interventions:
    • Device: active rTMS
    • Behavioral: Inpatient admission
  • Sham Comparator: Sham Stimulation
    Participants will be receiving sham stimulation with a smaller coil housed within the rTMS device.
    Interventions:
    • Behavioral: Inpatient admission
    • Device: sham rTMS
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 19, 2021) 		44
Original Estimated Enrollment  ICMJE
 (submitted: January 15, 2019) 		32
Estimated Study Completion Date  ICMJE December 30, 2022
Estimated Primary Completion Date December 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Current moderate to severe alcohol use disorder, per DSM-5
  2. Use of alcohol which parallels or exceeds the amount alcohol that will be administered in this study (1 drinking episode per week raising BAL to 0.03 g/dl - approximately 2 drinks within an hour).
  3. Age 22-55
  4. Able to give informed consent, and comply with study procedures
  5. Medically healthy, with the absence of current or past medical or neurological illnesses (including glaucoma, increased intracranial pressure, liver disease, cardiac disease, or seizure disorders)

Exclusion Criteria:

  1. Has a contraindication to MRI, such as magnetically reactive implants, which includes metal in head except in mouth (cochlear implant, implanted brain stimulators, aneurysm clips), cardiac pacemakers, implanted neurostimulators and medication pumps, and intracardiac lines.
  2. Substance use disorder with substances other than alcohol or nicotine. The current use of sedative-hypnotics or opiates will be exclusionary
  3. Meets DSM-5 criteria for other psychiatric illness, such as major depression, that would interfere with participation.
  4. History of seizures of any type
  5. A family history of epilepsy
  6. Taking psychotropic medication that would affect resting motor threshold (such as anticonvulsants) or increase risk of seizure (especially tricyclic antidepressants of neuroleptics)
  7. Current suicide risk or a history of suicide attempt within the past 2 years
  8. Have unstable physical disorders, including those that are previously undiagnosed, untreated, inadequately treated, or active to an extent which might make participation hazardous. For example, hypertension (a resting blood pressure > 140/90), heart failure, a recent history of myocardial infarction, previous stroke, brain lesions, any history of seizures under any circumstances or low hemoglobin.
  9. Currently pregnant
  10. History of severe alcohol withdrawal requiring medical care, such as withdrawal seizures, delirium tremens, withdrawal necessitating medical detoxification.
  11. A desire to pursue standard treatment for AUD, such as a rehabilitation program or FDA approved medications for AUD
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jonathan Wai, MD 646-774-7654 jonathan.wai@nyspi.columbia.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03809286
Other Study ID Numbers  ICMJE 7691
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jonathan Wai, New York State Psychiatric Institute
Study Sponsor  ICMJE New York State Psychiatric Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jonathan Wai New York State Psychiatric Institute
PRS Account New York State Psychiatric Institute
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

治疗医院

新药特效药

前沿医讯