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Neural Basis of Decision-Making Deficits in Traumatic Brain Injury

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ClinicalTrials.gov Identifier: NCT02169310
Recruitment Status : Recruiting
First Posted : June 23, 2014
Last Update Posted : August 16, 2018
Sponsor:
Collaborator:
Uniformed Services University of the Health Sciences
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )

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.

Condition or disease
Traumatic Brain Injury

Detailed Description:

Objectives

Deficits in decision-making are commonly found in individuals after traumatic brain injury (TBI) and can have a severe negative impact on quality of life. Converging evidence from both animal model and human studies suggest that decision-making deficits are linked with abnormal mesocorticolimbic network structure and function, and could potentially be mitigated through interventions that improve function within these neuronal circuits. The objectives of this protocol are to: (1) quantify differences in performance on a decision-making task between TBI patients and healthy volunteers; (2) determine whether baseline features of mesocorticolimbic network structure and function predict subsequent decision-making performance in both TBI patients and healthy volunteers; and (3) determine if facilitatory transcranial direct current stimulation (tDCS) applied over the dorsolateral prefrontal cortex (dlPFC), a mesocorticolimbic network region crucially involved in decision-making, improves decision-making after TBI.

Study Population

Up to 40 healthy adult volunteers and 40 TBI patients will be recruited under the protocol to participate in up to two experiments.

Design

We plan to accomplish the two objectives listed above within two experiments. Experiment 1 examines performance differences between TBI patients and healthy volunteers on a decision-making task, and explores whether baseline features of mesocorticolimbic network structure and function predict subsequent decision-making performance in TBI patients and healthy volunteers. Experiment 2, a proof-of-principle study, uses a sham-controlled, double-blind experimental design to examine whether facilitatory tDCS, a non-invasive intervention used recently to augment a range of cognitive functions, enhances decision-making performance in the same cohort of TBI patients and healthy volunteers.

Outcome Measures

The primary outcome measure for both Experiment 1 and 2 is performance in a computerized decision-making task. Secondary outcome measures will include quantitative estimates of structural and functional mesocorticolimbic network features, including MRI-based structural and functional connectivity, MEG-based functional dynamics, baseline dlPFC GABA concentration measured with magnetic resonance spectroscopy (MRS) imaging, dopamine D2 receptor binding potential within mesocorticolimbic subcortical nuclei measured with [11C]raclopride PET (Experiment 1). Multimodal data fusion modeling will be used to explore the predictive relationship between baseline mesocorticolimbic network states and decision-making task performance within a unified state-space framework (Experiment 1), as well as the ability of these network states to predict inter-individual differences in the effects of tDCS on decision-making task performance (Experiment 2).


Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Neural Basis of Decision Making Deficits in Traumatic Brain Injury
Study Start Date : June 19, 2014
Estimated Primary Completion Date : August 3, 2019
Estimated Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Performance in a computerized decision making task. [ Time Frame: Immediately after intervention; Up to 2 days post intervention ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02169310


Contacts
Contact: Ethan Buch, Ph.D. (301) 594-3979 buche@mail.nih.gov
Contact: Leonardo G Cohen, M.D. (301) 496-9782 cohenl1@mail.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
Sponsors and Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
Uniformed Services University of the Health Sciences
Investigators
Principal Investigator: Leonardo G Cohen, M.D. National Institute of Neurological Disorders and Stroke (NINDS)

Additional Information:
Publications:
Responsible Party: National Institute of Neurological Disorders and Stroke (NINDS)
ClinicalTrials.gov Identifier: NCT02169310     History of Changes
Other Study ID Numbers: 140083
14-N-0083
First Posted: June 23, 2014    Key Record Dates
Last Update Posted: August 16, 2018
Last Verified: March 22, 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) ):
Traumatic Brain Injury
Decision-Making
Dopaminergic Network
Brain Imaging
Non-Invasive Brain Stimulation

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System