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NCT06074328 · ClinicalTrials.gov registry record · NA
Blended Reality Immersion for Geriatric Head Trauma: The BRIGHT Study
A NA study of Traumatic Brain Injury, sponsored by University of Maryland, Baltimore.
- Completed
- Registry status
- NA
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT06074328: Completed NA study of Traumatic Brain Injury, sponsored by University of Maryland, Baltimore.
NCT06074328 is a NA study of Traumatic Brain Injury that has completed, run by University of Maryland, Baltimore. The registered enrollment target is 30 participants, below the 277-participant average among 171 other Traumatic Brain Injury trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06074328, a NA study of Traumatic Brain Injury, has completed, sponsored by University of Maryland, Baltimore.
- COMPLETED
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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
Conditions Studied
Interventions
- DEVICE Virtual Reality Neurocognitive Exercises administered through an Oculus Headset
Study Locations (1)
Maryland
- R Adams Cowley Shock Trauma Center - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2023-11-29 |
| Est. Completion | 2025-08-15 |
| Phase | NA |
What the finished NCT06074328 record still lists
NCT06074328 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 277-participant average among 171 other Traumatic Brain Injury trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Traumatic Brain Injury appearing as the primary indexed condition, and to 1 intervention - of which Virtual Reality Neurocognitive Exercises administered through an Oculus Headset is the first listed.
NCT06074328 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT06074328 about?
NCT06074328 is a clinical study titled "Blended Reality Immersion for Geriatric Head Trauma: The BRIGHT Study". 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 qu...
What is the current status of trial NCT06074328?
This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2023-11-29. Estimated completion is 2025-08-15.
What conditions does trial NCT06074328 study?
This clinical trial studies the following conditions: Traumatic Brain Injury.
What interventions are being tested in trial NCT06074328?
The interventions under investigation include: Virtual Reality Neurocognitive Exercises administered through an Oculus Headset (DEVICE).
Who is sponsoring clinical trial NCT06074328?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06074328 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06074328's enrollment target sits among peer trials
30 139th of 171 higher than 29 of 171 other Traumatic Brain Injury trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Traumatic Brain Injury trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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