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Completed

NCT Number: NCT06497413

Brain Vascular and Neurocognitive Health

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UT Arlington - Science and Engineering Innovation and Research Building

Arlington, Texas, 76010, United States

About this study

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:

  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Both men and women between the ages of 18-80 and of any race/ethnicity will be included in this study.

Exclusion criteria

  • Individuals who have donated more than 550 ml of blood within the past 8 weeks will not have blood drawn from them in this protocol. However, if they remain interested in the study, and otherwise meet the inclusion criteria, then the investigators may still opt to proceed with data collection.
  • Abnormal results from the blood screening will not impact eligibility for the study.
  • Individuals with brain injuries/surgeries in a year before the study and individuals who can not provide consent on their own will be excluded from participation.
  • Pregnant subjects, women who are breast feeding, and children (i.e. younger than 18) will not be recruited for the study. This will be assessed via self-report.
  • If a subject has any allergies to spandex/lycra, the subject will be excluded. However, latex allergies are not contraindicated.
  • Individuals with cardiac pacemakers and/or implantable cardioverter defibrillators and individuals with epilepsy will be excluded.

Treatment and study plan

transcranial photobiomodulation

Device

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.

Transcranial Photobiomodulation helmet (Neuradiant 1070 Plus) with no light administered

Device

In this condition the participants will wear the Transcranial Photobiomodulation helmet (Neuradiant 1070 Plus); however, the light will not be administered.

Primary outcomes

  1. Cerebral vasodilator function

    Time frame: Immediately before the start of the experimental or sham condition intervention. And immediately after the end of the experimental or sham condition intervention.

    This will be assessed as the increase in blood flow in the middle cerebral artery during a hypercapnic stimulus

  2. Neurocognitive function

    Time frame: Immediately before the start of the experimental or sham condition intervention. And immediately after the end of the experimental or sham condition intervention.

    This will be assessed using the NIH Toolbox which is a battery that consists of several cognitive challenges.

Sponsors and collaborators

Lead sponsor

The University of Texas at Arlington

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 11, 2024
Registry last updated
Oct 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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