Brain Vascular and Neurocognitive Health

NCT06497413 | Completed FDA Device

• 1 other identifier: 2024-0011
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

cerebral oxygenation; cognitive function; brain blood flow

Outcome Measures

Primary Outcomes (2)

• Cerebral vasodilator function

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

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

• Neurocognitive function

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

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

Study Arms (2)

Transcranial Photobiomodulation

EXPERIMENTAL

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.

Device: Transcranial Photobiomodulation

Sham condition

PLACEBO COMPARATOR

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

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

Interventions

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

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.

Sham condition

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas at Arlington: lead

Study Sites (1)

UT Arlington - Science and Engineering Innovation and Research Building

Arlington, Texas, 76010, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease; Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Robert M Brothers, PhD

  University of Texas at Arlington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The investigators will use a randomizer to assign the participant with either the experimental or sham treatment condition.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Individuals will be randomly assigned either an experimental or a control condition

Study Record Dates

• First Submitted: June 10, 2024
• First Posted: July 11, 2024
• Study Start: April 16, 2024
• Primary Completion: August 31, 2025
• Study Completion: September 17, 2025
• Last Updated: October 6, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)