Blended Reality Immersion for Geriatric Head Trauma: The BRIGHT Study

NCT06074328 | Completed FDA Device

• 1 other identifier: HP-00105456
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 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

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

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

  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

  7 weeks post enrollment

Study Arms (2)

No-VR Group

NO INTERVENTION

VR-Group

EXPERIMENTAL

Device: Virtual Reality Neurocognitive Exercises administered through an Oculus Headset

Interventions

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.

VR-Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

R Adams Cowley Shock Trauma Center

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Program In Trauma

Study Record Dates

• First Submitted: August 31, 2023
• First Posted: October 10, 2023
• Study Start: November 29, 2023
• Primary Completion: August 15, 2025
• Study Completion: August 15, 2025
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)