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OpenTrials
Completed

NCT Number: NCT06074328

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 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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

R Adams Cowley Shock Trauma Center

Baltimore, Maryland, 21201, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual Reality Neurocognitive Exercises administered through an Oculus Headset

Device

Virtual Reality Neurocognitive Exercises administered through an Oculus Headset as a form of neurorehabilitation in patients who suffer a traumatic brain injury.

Primary outcomes

  1. Change in the immediate memory domain score on the Repeatable Battery for Neuropsychological Assessment

    Time frame: 7 weeks post enrollment

    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

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Registry information

Official study title

Blended Reality Immersion for Geriatric Head Trauma: The BRIGHT Randomized Clinical Trial

Acronym: BRIGHT

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 10, 2023
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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