Clinical trial NCT06074328: Blended Reality Immersion for Geriatric Head Trauma: The BRIGHT Study
Official title: Blended Reality Immersion for Geriatric Head Trauma: The BRIGHT Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Traumatic Brain Injury
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 70
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in the immediate memory domain score on the Repeatable Battery for Neuropsychological Assessment
timeFrame: 7 weeks post enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: R Adams Cowley Shock Trauma Center
state: Maryland
Study officials:
References: