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Deep Brain Stimulation for Alcohol Use Disorder
Study Summary
This trial studies the safety and effectiveness of a brain stimulation treatment for people with severe alcohol use disorder and liver fibrosis.
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Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am willing and able to follow the study rules and attend all required visits.I don't have conditions that prevent me from having a brain MRI or surgery.I do not speak English.I do not have any recent major health issues affecting my brain.I am looking for treatment for my alcohol use disorder.I am between 21 and 75 years old.I have tried and failed to stay sober for over a year despite treatments in the last 5 years.I have advanced liver disease from alcohol use but don't show symptoms.I have severe liver disease with symptoms like swelling in the abdomen, confusion, yellowing skin, kidney issues, or bleeding in the esophagus.
- Group 1: AUD DBS
Frequently Asked Questions
Is this research protocol accommodating individuals of twenty years and above?
"According to the restrictions listed on the trial's eligibility criteria, potential participants must be over 21 and under 75 years of age."
How many participants is the clinical trial accepting?
"Indeed, the information on clinicaltrials.gov confirms that this research trial is currently recruiting candidates. The study was initially posted to the site on January 10th 2023 and most recently updated on April 1st of the same year. Presently 3 participants are required from a single location."
Are there currently any available slots for individuals to enroll in this clinical trial?
"Affirmative, the information on clinicaltrials.gov demonstrates that this study is currently seeking volunteers. It was originally listed on January 10th 2023 and updated on April 1st of the same year. Approximately 3 participants are necessary for recruitment from a single research site."
What are the requirements for joining this medical experiment?
"This clinical trial is in search of 3 adult participants, aged between 21 and 75, afflicted with a severe Alcohol Use Disorder (AUD) (>= 6 Diagnostic and Statistical Manual-5 AUD criteria). Furthermore, these individuals must exhibit an understanding of their own condition (scoring >26 on the recognition subscale of SOCRATES V.8), show signs of advanced compensated liver damage due to alcohol consumption (as diagnosed by a hepatologist or internist via elastography at >=15kiloPascal stiffness cutoff), have unsuccessfully treated their AUD over the past 5 years despite treatment attempts including pharmacotherapy/behavioral therapy programs such as residential"
What goals is this experiment striving to fulfill?
"Over the course of 4 to 52 weeks, this study's primary outcome will be an assessment of adverse events and their associated safety/tolerance. Secondary objectives include calculating percent days abstinent in order to gauge alcohol use, analysing overall functioning through WHODAS2.0 scores before and after activation, as well as measuring change in brain metabolism by utilizing 18fluoro-Deoxy-Glucose (FDG) PET scans pre and post DBS activations."
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