NCT06497413

Brain Vascular and Neurocognitive Health

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: The University of Texas at Arlington · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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, 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.

Conditions

• Cognitive Decline
• Cognitive Dysfunction
• Alzheimer Disease
• Vascular Disease, Peripheral

Interventions

Type	Name	Description
DEVICE	Transcranial Photobiomodulation	The transcranial photobiomodulation will be delivered through the Neuradiant 1070 Plus-Programmable 4-Quadrant Photobiomodulation System. This is a commercially available helmet that will be purchased from a commercially available source.
DEVICE	Transcranial Photobiomodulation helmet (Neuradiant 1070 Plus) with no light administered	In this condition the participants will wear the Transcranial Photobiomodulation helmet (Neuradiant 1070 Plus); however, the light will not be administered.

Timeline

• Start date: 2024-04-16
• Primary completion: 2025-08-31
• Completion: 2025-09-17
• First posted: 2024-07-11
• Last updated: 2025-10-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study