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Neurovascular and Mitochondrial Mechanisms of Transcranial Photobiomodulation in Vascular Mild Cognitive Impairment

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

The goal of this 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 people with mild cognitive impairment (MCI). The main questions it aims to answer are: * Does tPBM enhance cognitive function and cerebral hemodynamic responses during memory and finger tapping tasks? * Does tPBM reduce oxidative stress, inflammation, and mitigate brain cell damage? * Is cognitive improvement linked to amyloid status, greater cerebral hemodynamic response, 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 a 20-minute-long active tPBM or sham stimulation session once per day, 6 times per week, for 12 weeks. * 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). Dynamic analysis of the vessels in the eye will also be performed based on eligibility. Transcranial Doppler (TCD) flowmetry is optionally performed. * Provide blood samples to test for biomarkers of inflammation, oxidative stress, and brain cell damage.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 55
Maximum Age: 95
Healthy Volunteers: f
View:

• Age: 55-95 years of age

• Clinical Dementia Rating (CDR) equal to 0.5 and/or Montreal Cognitive Assessment (MoCA) \<26 and ≥19

• Adequate hearing and visual acuity to participate in the examinations

• English speaker

• Presence of cerebrovascular pathology confirmed by structural brain imaging method

Locations
United States
Oklahoma
University of Oklahoma Health Campus
RECRUITING
Oklahoma City
Contact Information
Primary
Peter Mukli
peter-mukli@ou.edu
+1 (405) 271-8001
Backup
Leslie Guthery
leslie-guthery@ou.edu
+1 (405) 271-4113
Time Frame
Start Date: 2025-10-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 40
Treatments
Active_comparator: Active near-infrared light therapy
Participants in this arm will receive 20-minute active transcranial photobiomodulation sessions six times a week for 12 weeks during their participation in the study. The intervention will be administered using an active Vielight Neuro RX-Duo, 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 20-minute sham transcranial photobiomodulation sessions six times a week for 12 weeks during their participation in the study. The intervention will be administered using a sham Vielight Neuro RX-Duo, 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