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Transcranial Magnetic Stimulation for Alcoholism
N/A
Waitlist Available
Led By Brett C Ginsburg, PhD
Research Sponsored by The University of Texas Health Science Center at San Antonio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Able to attend all study appointments
Be older than 18 years old
Must not have
Females will be excluded if they are pregnant
Psychiatrically or medically unsafe to participate due to a documented diagnostic history of bipolar disorder, schizophrenia or schizoaffective disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1 month and 6 months
Awards & highlights
No Placebo-Only Group
Summary
"This trial is testing a new treatment called IR-TMS to help people who drink too much alcohol reduce their alcohol intake. Participants will receive different versions of this treatment and undergo sessions, brain scans, and
Who is the study for?
This trial is for individuals struggling with Alcohol Use Disorder (AUD) who are seeking a new treatment option. Participants must be willing to undergo brain scans, provide samples, and answer questions about their drinking habits and mental health.
What is being tested?
The study tests IR-TMS, a non-invasive procedure using magnetic fields to target brain areas linked to addiction. It aims to reduce alcohol cravings by varying the treatment across three groups in multiple sessions alongside regular monitoring through MRI scans and sample collection.
What are the potential side effects?
While the description doesn't list specific side effects, TMS can sometimes cause discomfort at the stimulation site, headache, lightheadedness or seizures in very rare cases. The intensity of these side effects may vary.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can attend all required study visits.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not pregnant.
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I do not have a history of bipolar, schizophrenia, or schizoaffective disorder.
Select...
I have a history of serious medical or neurological conditions, including seizures.
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I have had a brain injury where I was unconscious for 20 minutes or more.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 1 month and 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1 month and 6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Measure of Phosphatidylethanol (PEth) level
Secondary study objectives
Brain functional connectivity
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Active Control
Group I: Orbitofrontal cortex (OFC) IR-TMSActive Control1 Intervention
Stimulation will be delivered to either the OFC at a depth corrected intensity of 80-95 V/m, using a theta burst stimulation protocol which delivers 1,800 pulses/session. Sessions will be compressed and delivered up to 4 times per day, over the course of 2 weeks.
Group II: Left dorsolateral prefrontal cortex (L-DLPFC) IR-TMSActive Control1 Intervention
Stimulation will be delivered to the L-DLPFC at a depth corrected intensity of 80-95 V/m, using a theta burst stimulation protocol which delivers 1,800 pulses/session. Sessions will be compressed and delivered up to 4 times per day, over the course of 2 weeks.
Group III: Dorsomedial prefrontal cortex (DMPFC) IR-TMSActive Control1 Intervention
Stimulation will be delivered to either the DMPFC at a depth corrected intensity of 80-95 V/m, using a theta burst stimulation protocol which delivers 1,800 pulses/session. Sessions will be compressed and delivered up to 4 times per day, over the course of 2 weeks.
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Who is running the clinical trial?
Wellcome Leap Inc.UNKNOWN
1 Previous Clinical Trials
129 Total Patients Enrolled
The University of Texas Health Science Center at San AntonioLead Sponsor
475 Previous Clinical Trials
92,166 Total Patients Enrolled
5 Trials studying Alcoholism
412 Patients Enrolled for Alcoholism
Brett C Ginsburg, PhDPrincipal InvestigatorThe University of Texas Health Science Center at San Antonio
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