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Age-specific Neurovascular Effects of Transcranial Photobiomodulation

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this pilot clinical trial is to test whether transcranial photobiomodulation (tPBM), a non-invasive brain stimulation technique using near-infrared light, can improve brain blood flow regulation (neurovascular coupling) and cognitive function in older adults. The main questions it aims to answer are: * Does tPBM enhance neurovascular coupling responses during memory and finger tapping tasks? * Are these improvements linked to better cognitive performance and lower levels of brain inflammation and oxidative stress? Researchers will compare an active tPBM treatment arm to a sham treatment arm to see if tPBM leads to measurable improvements in brain activity and cognitive function compared to no active stimulation. Participants will: * Receive either active tPBM or sham stimulation sessions for 4 weeks, every other day using a portable intervention device. * Complete questionnaires and an iPAD-based cognitive testing protocol * Complete memory and motor tasks while their brain activity is measured using non-invasive techniques: simultaneous functional near-infrared spectroscopy (fNIRS) and electroencephalography (EEG), transcranial doppler (TCD) flowmetry. * Retinal vessel reactivity will be measured during flickering light stimulus using a special camera (dynamic vessel analysis, DVA). * Provide blood samples to test for biomarkers of inflammation, oxidative stress and brain cell damage.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 85
Healthy Volunteers: t
View:

• Age: 21-85 years of age

• Adequate hearing and visual acuity to participate in the examinations

• Ability to read and write in English

• Competence to provide informed consent

Locations
United States
Oklahoma
University of Oklahoma Health Campus
RECRUITING
Oklahoma City
Contact Information
Primary
Peter Mukli, MD, PhD
peter-mukli@ou.edu
+1 (405) 271-8001
Backup
Norbert S Dosa, MD
norbert-dosa@ou.edu
+1 (405) 271-8130
Time Frame
Start Date: 2025-10-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 30
Treatments
Active_comparator: Active near-infrared light therapy
Participants in this arm will receive active transcranial photobiomodulation sessions every other day for 20 minutes during their participation in the study. The intervention will be administered by active Vielight Neuro Rx Gamma, a research version of a commercially available light therapy device categorized as a wellness product with non-significant risk. During these sessions, biologically effective near-infrared light will be administered.
Sham_comparator: Sham near-infrared light therapy
Participants in this arm will receive sham transcranial photobiomodulation sessions every other day for 20 minutes during their participation in the study. The intervention will be administered by active Vielight Neuro Rx Gamma, a research version of a commercially available light therapy device categorized as a wellness product with non-significant risk. During these sessions, biologically effective near-infrared light will not be administered.
Related Therapeutic Areas
Sponsors
Leads: University of Oklahoma

This content was sourced from clinicaltrials.gov