Brain Vascular and Neurocognitive Health

NCT ID: NCT06497413

Last Updated: 2025-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-16
• Study Completion Date: 2025-09-17

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, 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Transcranial Photobiomodulation

Transcranial Photobiomodulation (tPBM) is a novel and non-invasive strategy that utilizes a helmet that delivers 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.

Group Type: EXPERIMENTAL

Transcranial Photobiomodulation

Intervention Type: 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.

Sham condition

In this condition the participants will wear the Transcranial Photobiomodulation (tPBM) headgear; however, no light will be delivered.

Group Type: PLACEBO_COMPARATOR

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

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The University of Texas at Arlington

OTHER

Sponsor Role: lead

Responsible Party

Matthew Brothers

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert M Brothers, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Texas at Arlington

Locations

UT Arlington - Science and Engineering Innovation and Research Building

Arlington, Texas, United States

Countries

United States

Other Identifiers

2024-0011

Identifier Type: -

Identifier Source: org_study_id