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Blended Reality Immersion for Geriatric Head Trauma: The BRIGHT Study (BRIGHT)

Primary Purpose

Traumatic Brain Injury

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Virtual Reality Neurocognitive Exercises administered through an Oculus Headset
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Traumatic Brain Injury

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 65 years of age or older Diagnosed with a mild traumatic brain injury Community dwelling English speaking Live within a 30 mile radius from the trauma center Active phone number Able to provide informed consent Exclusion Criteria: Known history of cognitive impairment Known history of functional impairment History of seizure disorders Medical implantable devices ( pacemaker & defibrillator) Substance use disorder Other severe traumatic injuries to the neck, chest, abdomen, spine and pelvis

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    No-VR Group

    VR-Group

    Arm Description

    Outcomes

    Primary Outcome Measures

    Change in the immediate memory domain score on the Repeatable Battery for Neuropsychological Assessment
    individually administered test measuring attention, language, visuospatial/constructional abilities, and immediate and delayed memory. The SCORES range from 40-160 with a mean and standard deviation of 100 and 15. Higher score = better outcome

    Secondary Outcome Measures

    Full Information

    First Posted
    August 31, 2023
    Last Updated
    October 6, 2023
    Sponsor
    University of Maryland, Baltimore
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06074328
    Brief Title
    Blended Reality Immersion for Geriatric Head Trauma: The BRIGHT Study
    Acronym
    BRIGHT
    Official Title
    Blended Reality Immersion for Geriatric Head Trauma: The BRIGHT Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    October 1, 2025 (Anticipated)
    Study Completion Date
    October 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Maryland, Baltimore

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Traumatic brain injury (TBI) is a major public health concern, particularly among older adults (OAs) ≥ 65 years of age. Each year in the United States, TBI results in over 600,000 emergency department visits and hospitalizations among OAs. Mild TBI (mTBI) accounts for 80% of all TBI in OAs and is quite understudied in this rapidly growing population. mTBI, is mild in name only, as it can result in dysfunction in multiple cognitive domains, including attention, processing speed, executive functioning and memory and has been shown to be associated with progressive brain atrophy and increased susceptibility to neurodegenerative disorders. Cognitive rehabilitation therapy is an evidence-based approach that can successfully improve cognitive impairment following TBI. Virtual reality (VR) is emerging as a technology that can assess cognitive impairment and provide a neurorehabilitation modality (NRM) to improve cognitive decline post TBI. Not only can VR provide a variety of environments like those encountered in real life and be adapted to varying levels and types of cognitive disability, but it can also be used safely in a patient's home with minimal equipment. Yet, despite the promise of cognitive rehabilitation using VR among OAs, very few studies to date have assessed the efficacy of VR cognitive rehabilitation in TBI. The aim of this study is to assess the effect and collect data on the efficacy and feasibility of a virtual reality application as a neurorehabilitation modality on executive functioning (attention, immediate memory, and visual-spatial skills) in OAs with mTBI. The hypothesis is that The use of VR mediated cognitive exercises post mTBI will be associated with improved executive function at 6-weeks post-randomization compared to the control group.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Traumatic Brain Injury

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    70 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    No-VR Group
    Arm Type
    No Intervention
    Arm Title
    VR-Group
    Arm Type
    Experimental
    Intervention Type
    Device
    Intervention Name(s)
    Virtual Reality Neurocognitive Exercises administered through an Oculus Headset
    Intervention Description
    Virtual Reality Neurocognitive Exercises administered through an Oculus Headset as a form of neurorehabilitation in patients who suffer a traumatic brain injury.
    Primary Outcome Measure Information:
    Title
    Change in the immediate memory domain score on the Repeatable Battery for Neuropsychological Assessment
    Description
    individually administered test measuring attention, language, visuospatial/constructional abilities, and immediate and delayed memory. The SCORES range from 40-160 with a mean and standard deviation of 100 and 15. Higher score = better outcome
    Time Frame
    7 weeks post enrollment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 65 years of age or older Diagnosed with a mild traumatic brain injury Community dwelling English speaking Live within a 30 mile radius from the trauma center Active phone number Able to provide informed consent Exclusion Criteria: Known history of cognitive impairment Known history of functional impairment History of seizure disorders Medical implantable devices ( pacemaker & defibrillator) Substance use disorder Other severe traumatic injuries to the neck, chest, abdomen, spine and pelvis

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Blended Reality Immersion for Geriatric Head Trauma: The BRIGHT Study

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