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
About this trial
This is an interventional supportive care trial for Traumatic Brain Injury
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
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
NCT ID
NCT06074328
First Posted
August 31, 2023
Last Updated
October 6, 2023
Sponsor
University of Maryland, Baltimore
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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