An Early Prospective Study of the Traq™ Device for Characterization of Binocular Ocular Function in Normal Subjects and Subjects With Recent Traumatic Brain Injury (REB-001)
30. juli 2026 opdateret af: Rebiscan, Inc.
The early prospective study of Traq™ (an investigational binocular ophthalmic neurodiagnostic device) will measure binocular ocular functions (bilateral foveal fixation, foveal binocularity, and fovea-tracked saccadic latency) in normal subjects and those with history of mild-to moderate traumatic brain injury (mTBI).
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
An initial, single-center, prospective, non-masked, non-randomized, parallel-arm clinical study designed to collect Traq™ measurement data from normal subjects (normal arm) and subjects with a history of mild to moderate traumatic brain injury (mTBI) within the last six months (post-TBI arm) to characterize binocular ocular function measurement outcomes across the two study populations.
Undersøgelsestype
Observationel
Tilmelding (Anslået)
10
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Justin Shaka
- Telefonnummer: 857-600-0982
- E-mail: jgshaka@rebiscan.com
Studiesteder
-
-
Iowa
-
Waukee, Iowa, Forenede Stater, 50263
- Rekruttering
- Elite Eye Care/Elite Vision Therapy
-
Kontakt:
- Heidi Bell, OD
- Telefonnummer: 515-987-3937
- E-mail: heidibellod@gmail.com
-
-
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
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Eye care clinic patients
Beskrivelse
Inclusion Criteria:
- Age 12 years or older at the time of enrollment.
- Able to understand and sign an informed consent form (or with parent/guardian for subjects less than 18 years of age).
- Willing and able to complete all required study visits and test assessments.
- Subjects with no history of traumatic brain injury (normal arm).
- Subjects with a history of mild to moderate traumatic brain injury (mTBI) within the last six months, (post-TBI arm).
Exclusion Criteria:
- Concurrent participation in another drug or device clinical investigation.
- Subject with a history of eye disease which could reduce, or limit reflected polarized light from the retina, such as corneal scarring, cataract, glaucoma, degenerative retinal conditions (e.g., age-related macular degeneration, diabetic retinopathy), or other conditions which may decrease device signal reflectance.
- Subjects who are pregnant, planning to become pregnant, or are breastfeeding.
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 |
Intervention / Behandling |
|---|---|
|
Head trauma group
Subjects with history of head trauma within the prior 6 months
|
Participants will undergo non-invasive binocular ophthalmic neurodiagnostic measurements and ocular assessments.
No treatment or intervention will be administered as part of the study.
|
|
Controls
Subjects with no history of head trauma
|
Participants will undergo non-invasive binocular ophthalmic neurodiagnostic measurements and ocular assessments.
No treatment or intervention will be administered as part of the study.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Device Metrics
Tidsramme: Four individual scans through study completion: Day 0, Day 30, Day 60, Day 90.
|
A composite Traq score will be calculated on a scale of 0.00-to-2.00 at each visit. The score will be a calculated combination of the following, additional outcome measures:
|
Four individual scans through study completion: Day 0, Day 30, Day 60, Day 90.
|
|
Device Metrics
Tidsramme: Four individual scans through study completion: Day 0, Day 30, Day 60, Day 90.
|
Bilateral foveal fixation will be measured as a percentage (from 0.00-1.00%) of time in which both eyes fixate together during the scan.
|
Four individual scans through study completion: Day 0, Day 30, Day 60, Day 90.
|
|
Foveal fixation
Tidsramme: Four individual scans through study completion: Day 0, Day 30, Day 60, Day 90.
|
The device will capture each individual eye's ability to fixate as a percentage (from 0.00 to 1.00) of time during the scan.
A result will be provided for each individual eye.
|
Four individual scans through study completion: Day 0, Day 30, Day 60, Day 90.
|
|
Device outputs
Tidsramme: Four individual scans through study completion: Day 0, Day 30, Day 60, Day 90.
|
Fovea-tracked saccadic latency will be calculated in milliseconds to measure when fixation is attained and lost throughout the scan.
|
Four individual scans through study completion: Day 0, Day 30, Day 60, Day 90.
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Heidi Bell, OD, Elite Eye Car / Elite Vision Therapy
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 (Faktiske)
14. juli 2026
Primær færdiggørelse (Anslået)
1. oktober 2026
Studieafslutning (Anslået)
1. oktober 2026
Datoer for studieregistrering
Først indsendt
21. juli 2026
Først indsendt, der opfyldte QC-kriterier
30. juli 2026
Først opslået (Faktiske)
3. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
3. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
30. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- REB-001
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
UBESLUTET
IPD-planbeskrivelse
Data will be shared should legal or regulatory needs require such sharing.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ja
produkt fremstillet i og eksporteret fra U.S.A.
Ingen
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