- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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
Przegląd badań
Status
Warunki
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Kontakty i lokalizacje
Lokalizacje studiów
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Maryland
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Bethesda, Maryland, Stany Zjednoczone, 20814
- USUHS
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Metoda próbkowania
Badana populacja
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
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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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Ramy czasowe |
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Performance on the eye tracking measures
Ramy czasowe: Baseline
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Baseline
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Miary wyników drugorzędnych
Miara wyniku |
Ramy czasowe |
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Psychological symptoms
Ramy czasowe: Baseline
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Baseline
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Performance on the neurocognitive assessment battery
Ramy czasowe: Baseline
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Baseline
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Post-concussive symptoms
Ramy czasowe: Baseline (and telephone follow-up, for TBI group)
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Baseline (and telephone follow-up, for TBI group)
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Współpracownicy i badacze
Śledczy
- Główny śledczy: Mark Ettenhofer, Ph.D, Uniformed Services University of the Health Sciences
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- R072LP-SS3
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