Neural Basis of Decision-Making Deficits in Traumatic Brain Injury

NCT02169310 | Completed Phase 1 FDA Drug

• 2 other identifiers: 14008314-N-0083
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• The primary objective of this protocol is to: quantify differences in performance on a decision-making task between TBI patients and healthy volunteers.

  The primary outcome measure for both Experiment 1 and 2 is performance in a computerized decision-making task.

  Participation may be completed over the course of a week, or longer depending on participant s schedule and testing availability. Typically, individuals complete the full study with 4-7 days.

Secondary Outcomes (1)

• The secondary objectives of this protocol are to: determine whether baseline features of mesocorticolimbic network structure and function predict subsequent decision-making performance in both TBI patients and healthy volunteers; and determine i...

  Participation may be completed over the course of a week, or longer depending on participant s schedule and testing availability. Typically, individuals complete the full study with 4-7 days.

Study Arms (2)

1

EXPERIMENTAL

up to 40 adult TBI patients between the ages of 18 and 60

Device: tDCS; Drug: [11C] Raclopride

2

ACTIVE COMPARATOR

up to 40 adult healthy volunteers between the ages of 18 and 60

Device: tDCS

Interventions

tDCS DEVICE

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.

1; 2

[11C] Raclopride DRUG

\[11C\] 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.

1

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18 to 60
• Able to give consent
• Must be able to follow instructions and perform required tasks
• Absence of clinically significant abnormalities during neurological examination
• Age 18 to 60
• Able to give consent
• Must be able to follow instructions and perform required tasks.
• 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 a healthcare provider within 24 hours of the injury event
• History of self-reported complaints or clinical findings related to planning or decision-making deficits

You may not qualify if:

• 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 participants with childbearing capacity, 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

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead
• Uniformed Services University of the Health Sciences: collaborator

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Transcranial Direct Current Stimulation; Raclopride

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques; Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Leonardo G Cohen, M.D.

  National Institute of Neurological Disorders and Stroke (NINDS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2014
• First Posted: June 23, 2014
• Study Start: November 18, 2014
• Primary Completion: February 13, 2024
• Study Completion: February 13, 2024
• Last Updated: August 22, 2025

Record last verified: 2025-08

Locations

US (1)