Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06648642
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-16
Brief Title:
Image-guided Robot Navigated Transcranial Magnetic Stimulation TMS for Alcohol Use Disorder AUD
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Open-label Clinical Trial of IR-TMS Image-guided Robot-navigated Transcranial Magnetic Stimulation for AUD and Development of a Neurobiological Biomarker for Craving and Relapse Validated Using a Direct Biochemical Biomarker phosphatidylethanol of Alcohol Use
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is testing a new treatment called IR-TMS image-guided robot navigated transcranial magnetic stimulation to see if it can help people who drink too much alcohol to reduce the amount they drink Participants will be placed into one of three groups each receiving a slightly different version of this treatment The study involves going through a few sessions of IR-TMS having brain scans MRI providing blood and urine samples and answering questions about their drinking and mental health These activities are part of the study and arent usually part of regular treatment for alcohol use
IR-TMS is different from regular treatments like therapy or medication because it uses magnetic fields to target specific parts of the brain The goal is to see if this treatment can help reduce the urge to drink There are other options like sticking with therapy or medication which are less intense but have been used for a longer time
IR-TMS is different from regular treatments like therapy or medication because it uses magnetic fields to target specific parts of the brain The goal is to see if this treatment can help reduce the urge to drink There are other options like sticking with therapy or medication which are less intense but have been used for a longer time
Detailed Description:
Participants with AUD will undergo accelerated IR-TMS treatments and longitudinal fMRI scanning to determine treatment effects and durability Participants will be recruited and randomized to 1 of 3 treatment target site regions 1 Left dorsolateral prefrontal cortex 2 Dorsomedial prefrontal cortex or 3 Orbitofrontal Cortex Each participants target site region will be determined by personalized fMRI connectivity maps Participants will receive up to 4 IR-TMS treatments per day for up to 10 days total 40 accelerated IR-TMS treatments in an open-label clinical trial with an adaptive treatment design-if one target site region demonstrates superior treatment responses the remaining participant sample will undergo IR-TMS treatments on that target site
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None