Behavioral and Functional MRI Task Development, Implementation, and Testing



Status:Recruiting
Conditions:Psychiatric, Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 60
Updated:3/3/2019
Start Date:April 8, 2014
End Date:December 1, 2021
Contact:Reza Momenan, Ph.D.
Email:rezam@mail.nih.gov
Phone:(301) 451-6972

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Background:

- Scientists know that alcohol use disorders affect brain structure. They want to know more
about the effects of alcohol use disorders on a person s behavior. They want to develop tasks
that can be done inside a scanner that can help them better understand these effects in later
studies.

Objective:

- To develop tasks that investigate a person s behavior that can be used in later studies.

Eligibility:

- Inpatient participants of another study. They must be physically healthy right-handed
adults 18 60 years old.

- Healthy right-handed volunteers 18 60 years old.

Design:

- Participants will be screened with medical history and physical exam. They will have an
EKG to record heart activity. They will give blood and urine samples and have a
psychiatric interview.

- Participants will have between one and three visits.

- Participants will be asked about their alcohol drinking to see if they have an alcohol
use disorder.

- Participants will complete one of three simple computerized tasks either inside the
magnetic resonance imagining (MRI) scanner or outside of it.

- The MRI scanner takes pictures of the brain. The scanner is a metal cylinder.
Participants lie on a table that can slide in and out of the cylinder. They will be in
the scanner for about 60 minutes. They may have to lie still for up to 20 minutes. The
scanner makes loud knocking noises, but they will get earplugs.

Objective:

The purpose of this protocol is three-fold: 1) to develop tasks examining various cognitive,
motivational, and decision-making behaviors outside the scanner; 2) to modify, refine, and
verify the feasibility and applicability of tasks for functional magnetic resonance imaging
(fMRI) to measure intended concomitant brain activation; and 3) to examine equivalent or
surrogate signals using other devices such as electroencephalograph (EEG) and near infrared
spectrometer (NIRS) when the MR contraindication(s) are present in the participant.

Study population:

Healthy volunteers without an alcohol use disorder, and inpatient participants with alcohol
dependence as determined by the DSM-IV-TR or at least Moderate Alcohol Use Disorder as
determined by DSM-5.

Design:

The participants will pilot one or both aspects of this study depending on whether the task
is de novo or a modification to previously verified or published task.

Outcome measures:

The outcome is to develop and examine tasks that reliably measure specific cognitive,
motivational and decision-making behaviors and invoke associated brain systems and functions
in our targeted subject populations.

- INPATIENT PARTICIPANT WITH ALCOHOL DEPENDENCE:

1. We will study up to 100 male and 100 female individuals who meet criteria for
current alcohol dependence. Inpatient participants will be recruited from the
NIAAA protocol 14-AA-0181, Unit and Clinic Evaluation, Screening, Assessment, and
Management

2. INCLUSION CRITERIA:

1. Physically healthy;

2. Between 18-60 years of age (since age effects fMRI signal in ways that have
not yet been well-characterized);

3. EXCLUSION CRITERIA:

1. Are not cleared on a neuromotor examination;

2. Are currently receiving psychotropic medication;

3. Currently experiencing symptoms of withdrawal from alcohol (As determined by
the most recent measurement within the past 30 days CIWA score greater than
8).

MRI Exclusion Criteria:

1. Presence of ferromagnetic objects in the body including implanted pacemakers,
medication pumps, aneurysm clips, metallic prostheses (including metal pins and rods,
heart valves or cochlear implants), shrapnel fragments, permanent eye liner or small
metallic fragments in the eye that welders and other metal workers may have;

2. Are pregnant, as determined by a negative pregnancy test;

3. Left handed;

4. Claustrophobia;

HEALTHY VOLUNTEERS WITHOUT AN ALCOHOL USE DISORDER:

1. We will study up to 100 male and 100 female individuals who have never met criteria
for an alcohol use disorder and are between the age of 18 and 60 years and will be
recruited from the NIAAA creening protocols 98-AA-0009, Screening Evaluation for NIAAA
Protocols, and 14-AA-0181, Unit and Clinic Evaluation, Screening, Assessment, and
Management.

2. INCLUSION CRITERIA:

-Same as inpatient participants with alcohol dependence.

3. EXCLUSION CRITERIA:

- Same as inpatient participants with alcohol dependence (item 3 does not apply).
In addition, healthy control participants cannot have met DSM-IV or DSM-5
criteria for an alcohol use disorder at any time.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Phone: 800-411-1222
?
mi
from
Bethesda, MD
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