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The RETINA Project: Reliable Eye Tracking in Neurocognitive Assessment of Traumatic Brain Injury (RETINA)

14. december 2018 opdateret af: Mark Ettenhofer, Uniformed Services University of the Health Sciences

Eye Tracking Indicators of Neurocognitive Status After Traumatic Brain Injury

The purpose of this study is to develop and validate eye-tracking measures that can be used to evaluate neurocognitive dysfunction among individuals with traumatic brain injury (TBI).

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

183

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Maryland
      • Bethesda, Maryland, Forenede Stater, 20814
        • USUHS

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

The population to be studied will include civilians and military personnel with and without a history of traumatic brain injury / concussion.

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
TBI Group
Adults (civilian or military) with a history of one or more brain injuries / concussions.
Control Group
Healthy adults (civilian or military) with no history of brain injury.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Performance on the eye tracking measures
Tidsramme: Baseline
Baseline

Sekundære resultatmål

Resultatmål
Tidsramme
Psychological symptoms
Tidsramme: Baseline
Baseline
Performance on the neurocognitive assessment battery
Tidsramme: Baseline
Baseline
Post-concussive symptoms
Tidsramme: Baseline (and telephone follow-up, for TBI group)
Baseline (and telephone follow-up, for TBI group)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Uniformed Services University of the Health Sciences

Efterforskere

  • Ledende efterforsker: Mark Ettenhofer, Ph.D, Uniformed Services University of the Health Sciences

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2010

Primær færdiggørelse (Faktiske)

1. august 2015

Studieafslutning (Faktiske)

1. oktober 2017

Datoer for studieregistrering

Først indsendt

8. marts 2012

Først indsendt, der opfyldte QC-kriterier

12. marts 2012

Først opslået (Skøn)

13. marts 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. december 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. december 2018

Sidst verificeret

1. december 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • R072LP-SS3

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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