Neural Basis of Decision Making Deficits in Traumatic Brain Injury
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The primary objective of this protocol is to: quantify differences in performance on a decision-making task between TBI patients and healthy volunteers.
研究概览
简要总结
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.
详细描述
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:
- Quantify differences in performance on a decision-making task between TBI patients and healthy volunteers;
- Determine whether baseline features of mesocorticolimbic network structure and function predict subsequent decision-making performance in both TBI patients and healthy volunteers; and
- 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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1
up to 40 adult TBI patients between the ages of 18 and 60
干预措施: tDCS (Device)
1
up to 40 adult TBI patients between the ages of 18 and 60
干预措施: [11C] Raclopride (Drug)
2
up to 40 adult healthy volunteers between the ages of 18 and 60
干预措施: tDCS (Device)
结局指标
主要结局
The primary objective of this protocol is to: quantify differences in performance on a decision-making task between TBI patients and healthy volunteers.
时间窗: 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.
The primary outcome measure for both Experiment 1 and 2 is performance in a computerized decision-making task.
次要结局
- 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.)