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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)
Must not have
Substance use disorder with substances other than alcohol or nicotine. The current use of sedative-hypnotics or opiates will be exclusionary
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 weeks
Awards & highlights

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am healthy with no history of major illnesses like heart disease or seizures.
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not use drugs other than alcohol or nicotine, especially no sedatives or opiates.
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I cannot have an MRI due to metal implants not in my mouth or specific medical devices.
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I am not on medication that affects muscle control or increases seizure risk.
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I do not have any untreated or poorly managed health conditions that could make joining a study unsafe for me.
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I have had seizures before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
Change in GABA in the mPFC and ACC as measured with magnetic resonance spectroscopy (MRS).
Change in craving for alcohol measured using the Alcohol Urge Questionnaire (AUQ).
Changes in cognitive control as measured by using the Frontal Assessment Battery (FAB).

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
477 Previous Clinical Trials
153,984 Total Patients Enrolled
17 Trials studying Alcoholism
1,374 Patients Enrolled for Alcoholism
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
823 Previous Clinical Trials
1,161,262 Total Patients Enrolled
432 Trials studying Alcoholism
778,423 Patients Enrolled for Alcoholism
Jonathan WaiPrincipal Investigator - New York State Psychiatric Institute
New York State Psychiatric Institute

Media Library

rTMS (Brain Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT03809286 — N/A
Alcoholism Research Study Groups: Active Stimulation, Sham Stimulation
Alcoholism Clinical Trial 2023: rTMS Highlights & Side Effects. Trial Name: NCT03809286 — N/A
rTMS (Brain Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03809286 — N/A
~2 spots leftby Dec 2024
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