- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07635329
Home-based Vision Rehabilitation Guided by Brain Imaging (BRIGHT)
Behavioral Rehabilitation Through Image-Guided Home-based Training
The BRIGHT (Behavioral Rehabilitation Through Image-Guided Home-based Training) study aims to evaluate the effectiveness of image-guided, home-based perceptual training at improving visual performance in individuals with visual field loss.
Using a prospective, crossover design, BRIGHT combines visual behavioral testing, neuroimaging, and a home-based intervention. It aims to 1) identify neural pathways that support training-induced visual plasticity; and 2) compare the efficacy of different types of visual training delivered in a home-based setting.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Tina Liu, PhD
- Telefonnummer: 2027849920
- E-mail: tina.liu@georgetown.edu
Studiesteder
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District of Columbia
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Washington D.C., District of Columbia, Forenede Stater, 20057
- Rekruttering
- Georgetown University Medical Center
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Ledende efterforsker:
- Tina Liu, PhD
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Kontakt:
- Tina Liu, PhD
- Telefonnummer: 202-784-9949
- E-mail: vpplab@georgetown.edu
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- At least 18 years of age.
- Capable of providing informed consent and complying with study procedures.
- Unilateral or bilateral focal brain damage causing visual field loss.
- At least three months post-stroke or traumatic brain injury, or a stable brain tumor within the past year.
- Eligible for MRI based on standard safety screening.
Exclusion Criteria:
- Severe neurological or psychiatric conditions unrelated to the focal lesion that may interfere with study participation or data interpretation.
- Current or recent (within the past 6 months) drug or alcohol abuse or addiction as defined by DSM-5.
- Ocular disease or disorder.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Perceptual learning-based training using high-level visual stimuli
A 3 week at-home online perceptual learning-based training using high-level visual stimuli.
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Behavioral intervention consisting of repeated computerized visual discrimination tasks targeting higher-order visual processing
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Aktiv komparator: Perceptual learning-based training using low-level visual stimuli
A 3 week at-home online perceptual learning-based training using low-level visual stimuli.
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behavioral intervention consisting of repeated computerized visual discrimination tasks targeting low-level visual processing
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in high-level perceptual discrimination performance
Tidsramme: Week 2-4 or Week 7-9 of the study (depending on the order)
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Change in performance on an online computerized high-level perceptual discrimination task.
Participants complete a computerized high-level perceptual discrimination task during a 3-week training period (5 days per week).
Task difficulty is adaptively adjusted using a 3-up/1-down staircase procedure to estimate perceptual discrimination thresholds corresponding to approximately 75% accuracy.
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Week 2-4 or Week 7-9 of the study (depending on the order)
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Change in low-level perceptual discrimination performance
Tidsramme: Week 2-4 or Week 7-9 of the study (depending on the order)
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Change in performance on an online computerized low-level perceptual discrimination task.
Participants complete a computerized high-level perceptual discrimination task during a 3-week training period (5 days per week).
Task difficulty is adaptively adjusted using a 3-up/1-down staircase procedure to estimate perceptual discrimination thresholds corresponding to approximately 75% accuracy.
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Week 2-4 or Week 7-9 of the study (depending on the order)
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Neurologiske manifestationer
- Cerebrovaskulære lidelser
- Hjernesygdomme
- Sygdomme i centralnervesystemet
- Sygdomme i nervesystemet
- Karsygdomme
- Hjerte-kar-sygdomme
- Sår og skader
- Neoplasmer efter sted
- Neoplasmer
- Øjensygdomme
- Synsforstyrrelser
- Sensationsforstyrrelser
- Neoplasmer i nervesystemet
- Kraniocerebralt traume
- Traumer, nervesystemet
- Neoplasmer i centralnervesystemet
- Blindhed
- Hjerneskader
- Patologiske tilstande, tegn og symptomer
- Tegn og symptomer
- Hjerneskader, traumatiske
- Slag
- Neoplasmer i hjernen
- Hemianopsi
- Blindhed, kortikal
Andre undersøgelses-id-numre
- STUDY00010314
- 26CDA1590827 (Andet bevillings-/finansieringsnummer: American Heart Association)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Kliniske forsøg med High-level perceptual learning-based training
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University of Wisconsin, MadisonNational Eye Institute (NEI)Rekruttering