- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01552577
The RETINA Project: Reliable Eye Tracking in Neurocognitive Assessment of Traumatic Brain Injury (RETINA)
Eye Tracking Indicators of Neurocognitive Status After Traumatic Brain Injury
연구 개요
상태
정황
상세 설명
This study will evaluate a novel method of neurocognitive assessment using computerized eye tracking. This method involves looking at targets on a computer screen while an eye-tracking system records eye movements and changes in pupil diameter in response to the presentation of the targets.
Performance on the eye tracking measures will be evaluated to identify potential effects of neural injury on cognitive performance. Data from individuals with and without a history of brain injury will be used to standardize the eye tracking measure.
Participants will also complete a short interview and several self report measures, including information about demographic characteristics, medical history, and psychological symptoms, along with a series of neuropsychological/cognitive measures that are already well established. Performance on eye tracking measures will then be compared to performance on these conventional cognitive tests to allow comparison of the different measures.
All participants will complete one visit to the laboratory at USUHS in Bethesda, MD. This visit will take approximately 2.5 hours. Participants without a history of TBI may be asked to return for a 30 minute follow-up session in order to measure the reliability of the eye tracking system. Participants with a history of TBI will complete a 10 minute telephone follow-up 6 and 12 months after their visit.
Compensation is available for civilians who are not employed by the Federal government.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Maryland
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Bethesda, Maryland, 미국, 20814
- USUHS
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria (Control Group):
- 18 years of age or older
- No history of brain injury or concussion
- Fluency and literacy in English
- Can effectively communicate verbally
- Willing and able to provide written informed consent
- Obtains signed permission to participate from supervisor and/or brigade commander (federal civilian employees and active duty military personnel only).
Exclusion Criteria (Control Group)
- Impaired or fluctuating level of consciousness / arousal
- Any medical condition that could impair cognitive abilities (e.g. muscular dystrophy, multiple sclerosis, psychosis)
- History of any neurological conditions such as brain tumor, brain infection, seizure or stroke
- Any visual impairment that is not corrected by glasses/contacts
- Motor impairment or amputation of one or both upper extremities
Inclusion Criteria (TBI Group):
- 18 years of age or older
- History of one or more brain injuries / concussion
- Fluency and literacy in English
- Can effectively communicate verbally
- Willing and able to provide written informed consent
- Obtains signed permission to participate from supervisor and/or brigade commander (federal civilian employees and active duty military personnel only).
Exclusion Criteria (TBI Group)
- Impaired or fluctuating level of consciousness / arousal
- Any medical condition that could impair cognitive abilities (e.g. muscular dystrophy, multiple sclerosis, psychosis), other than TBI
- History of any neurological conditions (such as brain tumor, brain infection, seizure or stroke) that was NOT associated with or resulting from traumatic brain injury
- Any visual impairment that is not corrected by glasses/contacts
- Motor impairment or amputation of one or both upper extremities
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
|---|
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TBI Group
Adults (civilian or military) with a history of one or more brain injuries / concussions.
|
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Control Group
Healthy adults (civilian or military) with no history of brain injury.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Performance on the eye tracking measures
기간: Baseline
|
Baseline
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
Psychological symptoms
기간: Baseline
|
Baseline
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Performance on the neurocognitive assessment battery
기간: Baseline
|
Baseline
|
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Post-concussive symptoms
기간: Baseline (and telephone follow-up, for TBI group)
|
Baseline (and telephone follow-up, for TBI group)
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Mark Ettenhofer, Ph.D, Uniformed Services University of the Health Sciences
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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