NCT02169310

Neural Basis of Decision-Making Deficits in Traumatic Brain Injury

Neural Basis of Decision Making Deficits in Traumatic Brain Injury

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: National Institute of Neurological Disorders and Stroke (NINDS) · NIH
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Detailed description

Study Description: 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. Objectives: 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. Endpoints: Primary Endpoint: The primary outcome measure for both Experiment 1 and 2 is performance in a computerized decision-making task. Secondary Endpoints: Secondary outcome measures will include quantitative estimates of structural and functional mesocorticolimbic network features, including MRI-based structural and functional connectivity, MEG-based functional connectivity, 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 features and decision-making task performance within a unified state-space framework (Experiment 1), as well as the ability of these network features to predict inter-individual differences in the effects of tDCS on decision-making task performance (Experiment 2).

Conditions

• Traumatic Brain Injury

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2014-11-18
• Primary completion: 2024-02-13
• Completion: 2024-02-13
• First posted: 2014-06-23
• Last updated: 2025-08-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study