Study of Structural Imaging

Completed

• Conditions: Chemically-Induced Disorders; Alcohol Dependence; Alcohol-Related Disorders; Mental Disorders; Substance-Related Disorders

• Registration Number: NCT02564991
• Lead Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Brief Summary

Background:

The way alcohol affects brain structure has been widely studied. But the way it affects all parts of the brain is still unknown. Researchers want to use magnetic resonance imaging (MRI) scans to study brain structure and function. They hope this will help them better understand changes that happen in brain regions during treatment of alcohol use disorders.

Objectives:

To study changes in the brain by using MRI in people with and without alcohol use disorders. To study how brain changes affect gait, balance, cognitive ability, and behavior. To see how the brain recovers when alcohol use stops.

Eligibility:

People with alcohol dependence who are currently hospitalized in a particular unit at NIH.

Healthy volunteers 30 60 years old without an alcohol use disorder.

Design:

Participants will be screened under a separate protocol.

Participants will give a urine sample for a drug test and pregnancy test at each study visit. They will also have to pass a breath alcohol test.

At the first visit, participants will have an MRI. The scanner is a metal cylinder in a strong magnetic field. Participants will lie on a table that slides in and out of the cylinder.

They will do behavior and memory tasks outside the scanner.

They will have gait and balance tested. They will have to stand on both legs, stand on just one leg, and walk in a straight line. They will perform each task with eyes open, then with eyes closed.

They will have tests of memory, thinking, and problem solving.

Some participants will have a second visit. They will have another MRI and repeat some of the behavior and memory tasks.

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Detailed Description

Objective

The purpose of this protocol is to characterize cerebellar volumes and function in alcoholics and recovery of cerebellar volume and function during early abstinence. This study also investigates how cerebrocerebellar circuits contribute to cognitive and motor impairment in alcoholism.

Study Population

Healthy volunteers and Inpatient participants with alcohol use disorders.

Design

Participants will receive whole-brain structural imaging and assessment of cerebellar function at the time of admission and again at the time of discharge.

Outcome

The Primary outcome of this study is to assess recovery of cerebellar structure and function at the end of treatment compared to treatment entry measures.

Study Timeline

• Study First Submitted: 2015-09-30
• Study First Submitted QC: 2015-09-30
• Study First Posted: 2015-10-01
• Study Start: 2016-02-29
• Primary Completion: 2020-03-18
• Study Completion: 2020-03-18
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-03
• Last Update Posted: 2024-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The Primary outcome of this study is to assess recovery of cerebellar structure and function at the end of treatment compared to treatment entry measures.	Entry and End of Treatment	To assess recovery of cerebellar structure and function at the end oftreatment compared to treatment entry measures.

Trial Locations

Locations (1)

National Institutes of Health Clinical Center; 🇺🇸 Bethesda, Maryland, United States