跳至主要内容
临床试验/NCT07103200
NCT07103200招募中不适用

Evaluation of Decision-Making Fatigue After Traumatic Brain Injury (EDIFY)

University of Minnesota1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年9月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
Feasibility of using COGED and Bandit computerized assessments in evaluating Decision-Making Fatigue after TBI

研究概览

简要总结

This is a preliminary, prospective, cohort study to investigate the feasibility of using the COGED and Restless Bandit tasks after a mild to moderate traumatic brain injury as well as in healthy controls.

详细描述

This study aims to measure the effects of traumatic brain injury in the acute and subacute phases of recovery using these two noninvasive computerized assessments (COGED and bandit). All participants engaged in the study will participate in a total of three visits at Hennepin Healthcare Systems, Inc. (HHS). Each visit will consist of surveys and computerized assessments that will help researchers to understand the effects of decision-making on mental fatigue.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •for TBI Participants:
  • •Adults 18 years and older
  • •Diagnosis of a mild to moderate TBI (GCS > 8 on admission)
  • •Able to perform a computerized assessment
  • •Willing to attend all scheduled appointments
  • •Able to undergo the informed consent process
  • •Inclusion Criteria for Healthy Participants:
  • •Adults 18 years and older
  • •Able to perform a computerized assessment
  • •Willing to attend all scheduled appointments
  • •Able to undergo the informed consent process

排除标准

  • 未提供

研究组 & 干预措施

COGED

Active Comparator

The COGED task consists of the classic N-back task of working memory-based decision making, followed by a valuation phase. The N-back phase of the task allows calculation of cognitive performance of a working memory task. During valuation, participants receive titrating offers of differing amounts of money to perform different difficulty levels of the N-back. The result is an effort discounting curve used to measure the individual effort cost. Effort discounting curves show the perceived cognitive effort required to complete each level of the task relative to another (typically the 1-back).

干预措施: COGED (Behavioral)

Restless Bandit

Active Comparator

Participants are presented with three targets (decks of cards) on the screen, which they select with a mouse movement. Each of the three targets is associated with a hidden probability of reward, which drifts unpredictably and independently across trials. This encourages participants to "exploit" good options when they are available, but also occasionally to "explore "other targets, which could become better at any time. Eye Tracking is done at each visit while the participant completes the Restless Bandit tasks.

干预措施: Restless Bandit (Behavioral)

结局指标

主要结局

Feasibility of using COGED and Bandit computerized assessments in evaluating Decision-Making Fatigue after TBI

时间窗: 4 years

Feasibility will be calculated using the sum total number of patients who completed at least 80% of study procedures divided by the sum total number of patients, which is a proportion ranging from 0 to 1. We will then determine if that exceeds 0.5, with higher numbers indicating more feasible.

次要结局

  • Acceptability of using COGED and Bandit computerized assessments in evaluating Decision-Making Fatigue after TBI(4 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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