Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06276894
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-26
First Post:
2024-01-18
Brief Title:
Functional Near-Infrared Spectroscopy fNIRS Assessing Neural Activity During Virtual Reality Walking Intervention
Sponsor:
Craig Hospital
Organization:
Craig Hospital
Study Overview
Official Title:
Using Functional Near-Infrared Spectroscopy fNIRS to Assess Neural Activity During a Virtual Reality Walking Intervention A Feasibility Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
fNIRS
Brief Summary:
The purpose of this study is to evaluate the safety and feasibility of using a portable neuroimaging device called functional near-infrared spectroscopy fNIRS to successfully analyze fNIRS data in individuals with chronic TBI during treadmill training augmented with VR
Detailed Description:
Each year an estimated 29 million Americans sustain traumatic brain injuries TBI that result in emergency department visits hospitalizations and death Although there are many treatment strategies in the early weeks and months after TBI millions of individuals live with residual disability This residual chronic disability often includes significant impairments in functional abilities like mobility along with unresolved neurophysiological deficits Because better mobility is directly linked to improved quality of life and enhanced societal participation interventions designed to improve mobility in chronic TBI are essential
One candidate intervention that could improve mobility in chronic TBI is virtual reality VR VR systems are computer-based applications that allow an individual to view and dynamically interact with a simulated environment in real-time Evidence suggests that VR may enhance motor learning and ultimately neuroplasticity the ability to reorganize synaptic connections in response to learning as VR provides users with increased sensory stimulation a more immersive environment and real-time feedback VR has been used to improve balance and mobility deficits associated with multiple neurologic conditions including TBI Neuroimaging studies have found that VR engagement can activate various cortical networks including the visual cortex parietal cortex and premotor cortex among others which may impact motor outcomes Craig has been evaluating the impact of VR use in TBI since 2012 when they conducted a site-specific study evaluating VR balance training in the home in comparison to a written home exercise program Importantly it was found that both interventions elicited significant improvements in clinical measures of balance in individuals with chronic TBI but did not find between group differences
In the current Traumatic Brain Injury Model Systems TBIMS grant the investigator hypothesized that combining treadmill training TT and VR would increase cortical excitability which would concurrently enhance activation of the neuromuscular system Subsequently this intervention would improve walking balance and cognitive outcomes - as evaluated with gold standard clinical measures However more research is needed to test this hypothesis and address knowledge gaps as efficacy for TT VR has not been established specific responders to TT VR interventions have not been identified and the plausible mechanisms associated with response have not been established Specifically studies have not yet evaluated the relationship between clinical outcomes and cortical activation
To address these gaps the investigators are proposing a translational research approach Translational research integrates basic and clinical science to better understand disorders like chronic TBI and to create enhanced diagnostics and treatments to expedite recovery processes Here the investigators propose to pair a neuroscience method with clinical interventions in adults with chronic TBI Specifically they plan to use portable a neuroimaging device functional near-infrared spectroscopy fNIRS to measure neural activity during a TT VR intervention to support future research and clinical initiatives in VR
fNIRS is a neuroimaging technique that uses near-infrared light to evaluate changes in brain activity via proxy measures of oxygenated HbO and deoxygenated hemoglobin HbR Specifically following neural activity oxygen is pulled from hemoglobin resulting in an immediate increase of HbR Next the oxygen reduction elicits an increase in localized cerebral blood flow CBF - a mechanism called neurovascular coupling As CBF increases a greater concentration of HbO can be detected Both HbR and HbO have optical properties meaning that their concentrations can be measured with near-infrared light Thus fNIRS can detect localized neural activity by evaluating HbR and HbO and increases in HbO concentrations reflect site-specific increases in neural activity
In summary this proposed pilot study is designed to assess the feasibility of using portable fNIRS to measure neural activity during a TT VR intervention in adults with TBI Establishing feasibility will allow us to use fNIRS in future studies comparing different intervention types These outcomes will advance VR research and enhance the scientific understanding of clinical and physiological outcomes following VR interventions ultimately informing clinical care
One candidate intervention that could improve mobility in chronic TBI is virtual reality VR VR systems are computer-based applications that allow an individual to view and dynamically interact with a simulated environment in real-time Evidence suggests that VR may enhance motor learning and ultimately neuroplasticity the ability to reorganize synaptic connections in response to learning as VR provides users with increased sensory stimulation a more immersive environment and real-time feedback VR has been used to improve balance and mobility deficits associated with multiple neurologic conditions including TBI Neuroimaging studies have found that VR engagement can activate various cortical networks including the visual cortex parietal cortex and premotor cortex among others which may impact motor outcomes Craig has been evaluating the impact of VR use in TBI since 2012 when they conducted a site-specific study evaluating VR balance training in the home in comparison to a written home exercise program Importantly it was found that both interventions elicited significant improvements in clinical measures of balance in individuals with chronic TBI but did not find between group differences
In the current Traumatic Brain Injury Model Systems TBIMS grant the investigator hypothesized that combining treadmill training TT and VR would increase cortical excitability which would concurrently enhance activation of the neuromuscular system Subsequently this intervention would improve walking balance and cognitive outcomes - as evaluated with gold standard clinical measures However more research is needed to test this hypothesis and address knowledge gaps as efficacy for TT VR has not been established specific responders to TT VR interventions have not been identified and the plausible mechanisms associated with response have not been established Specifically studies have not yet evaluated the relationship between clinical outcomes and cortical activation
To address these gaps the investigators are proposing a translational research approach Translational research integrates basic and clinical science to better understand disorders like chronic TBI and to create enhanced diagnostics and treatments to expedite recovery processes Here the investigators propose to pair a neuroscience method with clinical interventions in adults with chronic TBI Specifically they plan to use portable a neuroimaging device functional near-infrared spectroscopy fNIRS to measure neural activity during a TT VR intervention to support future research and clinical initiatives in VR
fNIRS is a neuroimaging technique that uses near-infrared light to evaluate changes in brain activity via proxy measures of oxygenated HbO and deoxygenated hemoglobin HbR Specifically following neural activity oxygen is pulled from hemoglobin resulting in an immediate increase of HbR Next the oxygen reduction elicits an increase in localized cerebral blood flow CBF - a mechanism called neurovascular coupling As CBF increases a greater concentration of HbO can be detected Both HbR and HbO have optical properties meaning that their concentrations can be measured with near-infrared light Thus fNIRS can detect localized neural activity by evaluating HbR and HbO and increases in HbO concentrations reflect site-specific increases in neural activity
In summary this proposed pilot study is designed to assess the feasibility of using portable fNIRS to measure neural activity during a TT VR intervention in adults with TBI Establishing feasibility will allow us to use fNIRS in future studies comparing different intervention types These outcomes will advance VR research and enhance the scientific understanding of clinical and physiological outcomes following VR interventions ultimately informing clinical care
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None