Light Therapy for Mild Cognitive Impairment
(LTMC Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Peter Mukli, MD, PhD
Principal Investigator
Department of Neurosurgery, University of Oklahoma Health Campus, Oklahoma, USA
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
How Is the Trial Designed?
2
Treatment groups
Active Control
Placebo Group
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Oklahoma
Lead Sponsor
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