About 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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Active CNS disease including multiple sclerosis, uncontrolled seizures, active brain cancer
Cerebrovascular accident other than TIA within 60 days prior to Visit 0
Diagnosis of amyloid angiopathy
Major psychiatric disease, including major depression not controlled on medications, alcohol or drug abuse
Trial design
Treatments tested in this trial
- Active Vielight Neuro RX-Duo device -Active transcranial photobiomodulation
- Sham Vielight Neuro RX-Duo device -Sham transcranial photobiomodulation