- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03809286
The Effect of rTMS to the Prefrontal Cortex in Alcohol Use Disorder (MAGNA)
February 1, 2024 updated by: Jonathan Wai, New York State Psychiatric Institute
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Estimated)
44
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jonathan Wai, MD
- Phone Number: 646-774-7654
- Email: jonathan.wai@nyspi.columbia.edu
Study Locations
-
-
New York
-
New York, New York, United States, 10032
- Recruiting
- New York State Psychiatric Institute
-
Contact:
- Jonathan Wai
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
22 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Current moderate to severe alcohol use disorder, per DSM-5
- 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).
- Age 22-55
- Able to give informed consent, and comply with study procedures
- 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:
- 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.
- Substance use disorder with substances other than alcohol or nicotine. The current use of sedative-hypnotics or opiates will be exclusionary
- Meets DSM-5 criteria for other psychiatric illness, such as major depression, that would interfere with participation.
- History of seizures of any type
- A family history of epilepsy
- Taking psychotropic medication that would affect resting motor threshold (such as anticonvulsants) or increase risk of seizure (especially tricyclic antidepressants of neuroleptics)
- Current suicide risk or a history of suicide attempt within the past 2 years
- 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.
- Currently pregnant
- History of severe alcohol withdrawal requiring medical care, such as withdrawal seizures, delirium tremens, withdrawal necessitating medical detoxification.
- A desire to pursue standard treatment for AUD, such as a rehabilitation program or FDA approved medications for AUD
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Active Stimulation
Participants will be receiving active rTMS.
|
rTMS delivers magnetic stimulation to the brain by using an electromagnet to generate a current that can penetrate the scalp and skull.
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.
|
All subjects will be admitted to the hospital for a brief detoxification period followed by 3 weeks of abstinence.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
4 weeks
|
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.
|
10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
4 weeks
|
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.
|
4 weeks
|
Change in abstinence from alcohol following discharge assessed with the Time Line Follow Back Interview.
Time Frame: 10 weeks
|
10 weeks
|
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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.
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jonathan Wai, New York State Psychiatric Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 24, 2019
Primary Completion (Estimated)
December 30, 2024
Study Completion (Estimated)
December 30, 2024
Study Registration Dates
First Submitted
January 9, 2019
First Submitted That Met QC Criteria
January 15, 2019
First Posted (Actual)
January 18, 2019
Study Record Updates
Last Update Posted (Actual)
February 2, 2024
Last Update Submitted That Met QC Criteria
February 1, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 7691
- 1K23AA028295 (U.S. NIH Grant/Contract)
- 5R21AA026049 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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