Ignite Creation Date:
2024-05-06 @ 7:37 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06074328
Status:
RECRUITING
Last Update Posted:
2023-10-10
First Post:
2023-08-31
Brief Title:
Blended Reality Immersion for Geriatric Head Trauma The BRIGHT Study
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Blended Reality Immersion for Geriatric Head Trauma The BRIGHT Randomized Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BRIGHT
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 600000 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 patients 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None