Evaluation of Neurocognitive Driving Rehabilitation in Virtual Environments (NeuroDRIVE) as an Adjunctive Intervention for Traumatic Brain Injury
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- VR Driving, Cognitive test, and Symptoms
研究概览
简要总结
Background:
- People with traumatic brain injury (TBI) can have problems with thinking and everyday activities. They may have a higher risk for car accidents. NeuroDRIVE uses a virtual reality driving simulator. Researchers think it can help test and improve how people think and drive after TBI.
Objective:
- To test how NeuroDRIVE affects brain performance and driving safety.
Eligibility:
- People at least 18 years old with a history of TBI and who had a driver s license at some point. They must speak, read, and write English and be physically able to drive.
Design:
- Participants will be asked to release their driving records, but they do not have to do this to be in the study.
- Visit 1: Screening physical exam.
- Visit 2: Magnetic resonance imaging (MRI) scan. Participants will lie on a table that slides into a cylinder with a strong magnetic field. A device will be placed over the head. Participants may do computer tasks during the scan.
- Participants will have tests of memory, attention, and thinking. They may be asked questions, take tests, and do simple actions.
- Visit 3: Tests of memory, attention, and thinking, plus a virtual reality driving assessment.
- Participants will be assigned to Group 1 to start NeuroDRIVE training immediately or Group 2 to start 10 weeks later.
- Visits 4 9, over 4 weeks:
- Participants will practice driving skills and mental exercises in the simulator.
- They will complete a driving questionnaire online each week.
- Visit 10: Repeat of Visit 3, with some small changes.
- Visits 11-12: Very similar to Visits 1-2. Includes MRI scan; physical exam; questionnaires; and tests of thinking, memory, and attention..
- After Visit 12: Participants will fill out a weekly driving survey online for 4 weeks.
详细描述
OBJECTIVE:
The primary objective of this study is to evaluate the NeuroDRIVE behavioral intervention for enhancement of driving abilities, cognitive abilities, and neurobehavioral symptoms after traumatic brain injury (TBI). For the purposes of this protocol, NeuroDRIVE refers to the novel combined approach of driving training and cognitive rehabilitation in a virtual reality environment. While NeuroDRIVE utilizes the VR system as the method through which the intervention is administered, NeuroDRIVE is not the VR system itself.
STUDY POPULATION:
30 adult patients with a history of mild TBI and 30 adult patients with a history of moderate-to-severe TBI. Participants will be recruited from the National Institutes of Health (NIH), WRNMMC, and the broader community.
DESIGN:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
VR Driving, Cognitive test, and Symptoms
时间窗: pre/post after 16 weeks of intervention
-Results from the Virtual Reality Driving Assessment (baseline and post- intervention Tactical scenario composite scores)-Total scores on the Neurobehavioral Symptom Inventory-Standard and scaled scores from the following cognitive assessments (from the TBI Common Data Elements identified by NINDS):--WAIS-IV Digit Span subtest--WAIS-IV Digit-Symbol--Coding subtest
次要结局
- MRI, Phenotyping, & Driving evals(Ongoing)