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Blended Reality Immersion for Geriatric Head Trauma: The BRIGHT Study

University of Maryland Baltimore (UMB) logo

University of Maryland Baltimore (UMB)

Status

Completed

Conditions

Traumatic Brain Injury

Treatments

Device: Virtual Reality Neurocognitive Exercises administered through an Oculus Headset

Study type

Interventional

Funder types

Other

Identifiers

NCT06074328
HP-00105456

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

65+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

30 participants in 2 patient groups

No-VR Group
No Intervention group
VR-Group
Experimental group
Treatment:
Device: Virtual Reality Neurocognitive Exercises administered through an Oculus Headset

Trial contacts and locations

1

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Central trial contact

Mira Ghneim

Data sourced from clinicaltrials.gov

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