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Brain Stimulation
rTMS for Alcoholism (MAGNA Trial)
N/A
Recruiting
Led By Jonathan Wai
Research Sponsored by New York State Psychiatric Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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)
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 weeks
Awards & highlights
MAGNA Trial Summary
This trial will test whether targeting a deeper brain region with rTMS can help patients with AUD by reducing alcohol consumption.
Who is the study for?
This trial is for adults aged 22-55 with moderate to severe alcohol use disorder who drink at least once a week. They must be medically healthy, without major illnesses or psychiatric conditions that could affect the study, not currently pregnant, and have no history of seizures or family epilepsy.Check my eligibility
What is being tested?
The study tests deep rTMS brain stimulation on frontal regions involved in memory and decision-making in patients with alcohol use disorder. It aims to see if this can reduce alcohol craving and consumption compared to a sham treatment.See study design
What are the potential side effects?
rTMS may cause discomfort at the stimulation site, headache, lightheadedness, or twitching facial muscles during treatment. There's also a small risk of seizure but it's generally considered safe.
MAGNA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am healthy with no history of major illnesses like heart disease or seizures.
Select...
I drink about 2 alcoholic drinks in an hour at least once a week.
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I am between 22 and 55 years old.
MAGNA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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.
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0.
Secondary outcome measures
Change in GABA in the mPFC and ACC as measured with magnetic resonance spectroscopy (MRS).
Change in abstinence from alcohol following discharge assessed with the Time Line Follow Back Interview.
Change in craving for alcohol measured using the Alcohol Urge Questionnaire (AUQ).
+1 moreMAGNA Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active StimulationExperimental Treatment2 Interventions
Participants will be receiving active rTMS.
Group II: Sham StimulationPlacebo Group2 Interventions
Participants will be receiving sham stimulation with a smaller coil housed within the rTMS device.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
active rTMS
2013
N/A
~50
Find a Location
Who is running the clinical trial?
New York State Psychiatric InstituteLead Sponsor
475 Previous Clinical Trials
153,863 Total Patients Enrolled
17 Trials studying Alcoholism
1,374 Patients Enrolled for Alcoholism
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
801 Previous Clinical Trials
1,365,241 Total Patients Enrolled
423 Trials studying Alcoholism
985,664 Patients Enrolled for Alcoholism
Jonathan WaiPrincipal Investigator - New York State Psychiatric Institute
New York State Psychiatric Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am healthy with no history of major illnesses like heart disease or seizures.You have a mental health condition, like major depression, that would make it difficult for you to take part in the study.You have a serious problem with drinking alcohol, as defined by the DSM-5.I drink about 2 alcoholic drinks in an hour at least once a week.I do not use drugs other than alcohol or nicotine, especially no sedatives or opiates.My family has a history of epilepsy.I cannot have an MRI due to metal implants not in my mouth or specific medical devices.I am not on medication that affects muscle control or increases seizure risk.You have recently attempted suicide or are currently at risk of attempting suicide.I want to follow standard treatments for alcohol use disorder.I do not have any untreated or poorly managed health conditions that could make joining a study unsafe for me.I am between 22 and 55 years old.I have had seizures before.
Research Study Groups:
This trial has the following groups:- Group 1: Active Stimulation
- Group 2: Sham Stimulation
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are being included in this experiment?
"Affirmative. The online record of clinicaltrials.gov reveals that this investigation is actively recruiting patients, with a first posting date on June 24th 2019 and the most recent modification done on November 3rd 2022. In total, 44 individuals need to be recruited from one centre for participation in the experiment."
Answered by AI
Is this investigation enrolling geriatric participants?
"This trial has a specific age range of 22 to 55 as requirements for inclusion. This is despite the fact that there are more studies with 279 and 820 participants respectively who fall outside of this demographic."
Answered by AI
Is this experiment presently seeking participants?
"Affirmative. Information found on clinicaltrials.gov suggests that this scientific study, which was added to the website on June 24th 2019, is enrolling participants at present time. The research requires 44 patients from a single medical centre."
Answered by AI
What type of individuals are deemed suitable participants in this trial?
"This scientific exploration is accepting 44 individuals between the ages of 22 and 55 afflicted with alcohol use disorder. Furthermore, they must also be medically sound and have no history of medical or neurological illnesses such as glaucoma, increased intracranial pressure, liver disease, cardiac issues or seizure disorders."
Answered by AI
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