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NCT02169310 · ClinicalTrials.gov registry record · Phase 1
Neural Basis of Decision-Making Deficits in Traumatic Brain Injury
A Phase 1 study of Traumatic Brain Injury, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Completed
- Registry status
- Phase 1
- Development phase
- 45
- Enrollment target
- 1
- Study location
NCT02169310: Completed Phase 1 study of Traumatic Brain Injury, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
NCT02169310 is a Phase 1 study of Traumatic Brain Injury that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 45 participants, below the 277-participant average among 171 other Traumatic Brain Injury trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02169310, a Phase 1 study of Traumatic Brain Injury, has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 45 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
The primary outcome measure for both Experiment 1 and 2 is performance in a computerized decision-making task.
Conditions Studied
Interventions
- DEVICE tDCS
- DRUG [11C] Raclopride
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2014-11-18 |
| Est. Completion | 2024-02-13 |
| Phase | Phase 1 |
What the finished NCT02169310 record still lists
NCT02169310 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 277-participant average among 171 other Traumatic Brain Injury trials with a reported enrollment target (84% lower).
The record links to 1 condition, with Traumatic Brain Injury appearing as the primary indexed condition, and to 2 interventions - of which tDCS is the first listed.
NCT02169310 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT02169310 about?
NCT02169310 is a clinical study titled "Neural Basis of Decision-Making Deficits in Traumatic Brain Injury". 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 ...
What is the current status of trial NCT02169310?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2014-11-18. Estimated completion is 2024-02-13.
What conditions does trial NCT02169310 study?
This clinical trial studies the following conditions: Traumatic Brain Injury.
What interventions are being tested in trial NCT02169310?
The interventions under investigation include: tDCS (DEVICE), [11C] Raclopride (DRUG).
Who is sponsoring clinical trial NCT02169310?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02169310 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02169310's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Traumatic Brain Injury trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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