Ignite Creation Date:
2024-07-17 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06497413
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-06-10
Brief Title:
Brain Vascular and Neurocognitive Health
Sponsor:
The University of Texas at Arlington
Organization:
The University of Texas at Arlington
Study Overview
Official Title:
Brain Vascular and Neurocognitive Health
Status:
RECRUITING
Status Verified Date:
2024-07
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:
None
Brief Summary:
The overall research objective of this proposal is to determine the acute and chronic impact of transcranial photobiomodulation on indices of cerebral vascular health and neurocognitive function
Detailed Description:
Neurocognitive conditions and diseases including cognitive dysfunction Alzheimers disease and related dementias ADRD are among the fastest growing causes of morbidity and mortality ADRDs impact 5 million people in the United States alone and 47 million people worldwide The physiological reasons for these conditions are multifactorial but one contributing factor is impaired cerebral vascular functionhealth Importantly impaired cerebral vascular functionhealth results in cerebral hypoperfusion thereby contributing to neuronal damage and neurodegenerative processes ultimately contributing to the aforementioned neurocognitive impairments Furthermore it is critical to investigate therapeutic strategies to combat this elevated risk One promising approach is Transcranial Photobiomodulation tPBM which is a novel and non-invasive strategy that utilizes low-level laser therapy to activate intracellular enzymatic pathways leading to an increase in mitochondrial activity cerebral oxygenation and thus neural and overall brain function Importantly this approach improves cognitive function in various animal models and limited human populations Furthermore there is limited evidence to suggest that these neurocognitive improvements are in-part related to increases in cerebral blood flow and cerebral vascular functionhealth However information regarding the mechanisms and effectiveness of tPBM are still relatively unknown - which represents a critical knowledge gap in the literature
Therefore the overall research objective is of this proposal is to determine the impact of tPBM on indices of neurocognitive and cerebral vascular health The following objectives aims will be explored
1 Primary Aim - The primary endpoint is the effect of acute ie one-time and repeated ie up to 8 times in a 4-week period exposure to tPBM on outcomes associated with elevated risk for various neurocognitive and pathophysiological conditionsdiseases These outcomes include neurocognitive function and indices cerebral blood vessel functionhealth
2 It is hypothesized that both acute and repeated exposure to tPBM will have a beneficial impact on the outcome variables of neurocognitive function and indices cerebral blood vessel functionhealth
Therefore the overall research objective is of this proposal is to determine the impact of tPBM on indices of neurocognitive and cerebral vascular health The following objectives aims will be explored
1 Primary Aim - The primary endpoint is the effect of acute ie one-time and repeated ie up to 8 times in a 4-week period exposure to tPBM on outcomes associated with elevated risk for various neurocognitive and pathophysiological conditionsdiseases These outcomes include neurocognitive function and indices cerebral blood vessel functionhealth
2 It is hypothesized that both acute and repeated exposure to tPBM will have a beneficial impact on the outcome variables of neurocognitive function and indices cerebral blood vessel functionhealth
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None