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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.
Neurocognitive conditions and diseases including cognitive dysfunction, Alzheimer's 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 function/health. Importantly, impaired cerebral vascular function/health 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 function/health. 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 (i.e. one-time) and repeated (i.e. up to 8 times in a 4-week period) exposure to tPBM on outcomes associated with elevated risk for various neurocognitive and pathophysiological conditions/diseases. These outcomes include neurocognitive function and indices cerebral blood vessel function/health. 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 function/health.
Age
18 - 80 years
Sex
ALL
Healthy Volunteers
Yes
UT Arlington - Science and Engineering Innovation and Research Building
Arlington, Texas, United States
Start Date
April 16, 2024
Primary Completion Date
August 31, 2025
Completion Date
September 17, 2025
Last Updated
October 6, 2025
24
ACTUAL participants
Transcranial Photobiomodulation
DEVICE
Transcranial Photobiomodulation helmet (Neuradiant 1070 Plus) with no light administered
DEVICE
Lead Sponsor
The University of Texas at Arlington
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04123314