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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 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.

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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.

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

FieldValue
Enrollment Target 30 participants
Start Date 2023-11-29
Est. Completion 2025-08-15
Phase NA

Sponsor

University of Maryland, Baltimore

560 total trials

What the Registry Record Tells You About NCT06074328

The ClinicalTrials.gov registry entry for NCT06074328 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 277-participant average among 171 other Traumatic Brain Injury trials with a reported enrollment target (89% lower). The listed sponsor is University of Maryland, Baltimore, which has 560 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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