Neural Basis of Decision-Making Deficits in Traumatic Brain Injury

Summary

Background:

People with a traumatic brain injury (TBI) can have trouble making the best possible decisions. Researchers want to learn more about the parts of the brain that control decision making. They also want to know how these are different between people. This may help predict how people make decisions after TBI.

Objective:

To learn more about which parts of the brain are involved in making decisions and how decisions may be hurt after TBI.

Eligibility:

Adults age 18 to 60.

Design:

Participants will be screened with medical history and physical exam. They will also take memory, attention, concentration, and thinking tests.

Participants will do up to 2 experiments.

For Experiment 1, participants may have 3 scans:

PET: a chemical is injected through a thin tube into an arm vein. Participants lie on a bed that slides in and out of the scanner.

MRI: a strong magnetic field and radio waves take pictures of the brain. Participants lie on a table that slides in and out of a metal cylinder. It makes loud knocking noises. Participants will get earplugs. They might be asked to do a task. A coil will be placed over the head.

MEG: a cone with magnetic field detectors is lowered onto participants head.

After the scans, participants will perform a decision-making task.

For Experiment 2, participants will perform a decision-making task before and after receiving transcranial direct current stimulation (tDCS).

tDCS: wet electrode sponges are placed over participants' scalp and forehead. A current passes between the electrodes. It stimulating the brain.

Participants will return 24-48 hours later to repeat the decision-making task.

Conditions

• Traumatic Brain Injury

Interventions

DEVICE

tDCS

There is no study intervention for Experiment 1. The study intervention for Experiment 2 is tDCS. tDCS is a non-invasive brain stimulation technique that uses electrodes attached to the scalp to deliver very low intensity direct current to the brain. This intervention has been demonstrated to result in neuromodulatory effects.

DRUG

[11C] Raclopride

\[11C\] Raclopride is administered under an IND 054135. This IND is sponsored by the NIH Clinical Center and \[11C\] Raclopride is dispensed by the NIH PET Department. Quality Assurance for Radioactive Drug: \[11C\] Raclopride, is assayed for radiochemical purity under the supervision of the NIH PET Department prior to dispensing the drug for administration. Given that IND PET drugs manufactured at the NIH PET Department are used in a single site and that there is no intent for their commercialization, submission of IBs has not been required by FDA for any of the NIH Office of Research Support and Compliance-sponsored IND applications.

Sponsors & Collaborators

• Uniformed Services University of the Health Sciences

  collaborator FED

• National Institute of Neurological Disorders and Stroke (NINDS)

  lead NIH

Principal Investigators

• Leonardo G Cohen, M.D. · National Institute of Neurological Disorders and Stroke (NINDS)

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2014-11-18

Primary Completion

2024-02-13

Completion

2024-02-13

FDA Drug

Yes

Countries

• United States

Study Locations