Blended Reality Immersion for Geriatric Head Trauma: The BRIGHT Study

Sponsor
University of Maryland, Baltimore (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06074328
Collaborator
(none)
70
2
24

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Virtual Reality Neurocognitive Exercises administered through an Oculus Headset
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Blended Reality Immersion for Geriatric Head Trauma: The BRIGHT Randomized Clinical Trial
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Oct 1, 2025
Anticipated Study Completion Date :
Oct 1, 2025

Arms and Interventions

Arm Intervention/Treatment
No Intervention: No-VR Group

Experimental: VR-Group

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Maryland, Baltimore

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Maryland, Baltimore
ClinicalTrials.gov Identifier:
NCT06074328
Other Study ID Numbers:
  • HP-00105456
First Posted:
Oct 10, 2023
Last Update Posted:
Oct 10, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 10, 2023