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Protocol Details

Neural Basis of Decision Making Deficits in Traumatic Brain Injury

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

14-N-0083

Sponsoring Institute

National Institute of Neurological Disorders and Stroke (NINDS)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18
Max Age: 60

Referral Letter Required

No

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

Traumatic Brain Injury;
Decision-Making;
Dopaminergic Network;
Brain Imaging;
Non-Invasive Brain Stimulation

Recruitment Keyword(s)

None

Condition(s)

Traumatic Brain Injury

Investigational Drug(s)

11-C-Raclopride

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Neurological Disorders and StrokeCenter for Neuroscience and Regenerative Medicine, Uniformed Services University of Health Sciences

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.

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Eligibility

INCLUSION CRITERIA

-Age 18 to 60

-Able to give consent

-Must be able to follow instructions and perform required tasks

-For healthy volunteers, absence of clinically significant abnormalities during

neurological examination

Additional Inclusion Criteria for TBI:

-History of having a sustained, traumatically induced (e.g., collision between the head and an object, or sudden acceleration/deceleration of the brain without direct

external trauma to the head) physiological disruption of brain function, as manifested by at least one of the following (based on the American Congress of Rehabilitation Medicine Criteria):

--Any period of loss of consciousness

--Any loss of memory for events immediately before or after the accident

--Focal neurological deficit(s) that may or may not be transient

--Any alteration in mental state at the time of the accident (e.g., feeling dazed, disoriented, or confused)

--Presentation to an Emergency Department within 24 hours of the injury event

--History of self-reported complaints or clinical findings related to planning or decision-making deficits

EXCLUSION CRITERIA

-Pre-existing and disabling major psychiatric (e.g., schizophrenia, bipolar disorder or post-traumatic stress disorder) or neurological disease (e.g., stroke, dementia, epilepsy, or multiple sclerosis).

-Present use of prescribed stimulants (e.g., methylphenidate or amphetamines)

-Present use of prescribed dopamine agonists/antagonists other than amantadine

-For female participants, pregnancy (for MRI and PET procedures) or nursing (for PET procedures only)

-Contraindication to PET procedures (for PET procedures only)

-Contraindication to MRI procedures as per MRI Center screening questionnaire (for MRI procedures only)

-Inability to participate in at least two of the imaging procedures (PET, MRI or MEG) due to contraindications

-Staff from our section

-For TBI patients, history of a penetrating head wound

-For healthy volunteers, history of any type of traumatically induced head injury resulting in presentation to an Emergency Department within 24 hours of the injury event


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Citations:

Agnew WF, McCreery DB. Considerations for safety in the use of extracranial stimulation for motor evoked potentials. Neurosurgery. 1987 Jan;20(1):143-7.

Bergsneider M, Hovda DA, McArthur DL, Etchepare M, Huang SC, Sehati N, Satz P, Phelps ME, Becker DP. Metabolic recovery following human traumatic brain injury based on FDG-PET: time course and relationship to neurological disability. J Head Trauma Rehabil. 2001 Apr;16(2):135-48.

Bonatti E, Zamarian L, Wagner M, Benke T, Hollosi P, Strubreither W, Delazer M. Making decisions and advising decisions in traumatic brain injury. Cogn Behav Neurol. 2008 Sep;21(3):164-75. doi: 10.1097/WNN.0b013e318184e688.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Leonardo G. Cohen, M.D.
National Institute of Neurological Disorders and Stroke (NINDS)
BG 10 RM 7D54
10 CENTER DR
BETHESDA MD 20814
(301) 496-9782
cohenl1@mail.nih.gov

Ethan Buch, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
National Institutes of Health
Building 10
Room 5S208
10 Center Drive
Bethesda, Maryland 20892
(301) 594-3979
buche@mail.nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT02169310

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