Using Light Therapy for Mild Cognitive Impairment
Recruiting · NCT07651787 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Oklahoma
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 can take part
Inclusion criteria
- 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
Exclusion criteria
- 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
- Neurodegenerative diseases, e.g: Parkinson's, any kind of dementia
- Patients currently using commercial brain stimulation / neuromodulation device as part of a research study
- Patients currently take dietary supplements with an expected cerebrovascular benefit such as NAD- or NR-supplementum, L-citrullin, urolithin
- Unstable medical condition, including uncontrolled diabetes, chronic heart issues, heart failure, chronic obstructive pulmonary disease, hypertension uncontrolled by medication (\>160/100 mmHg)
- Any other medical condition or medication which, in the opinion of investigator, would render the patient too unstable to complete the study protocol
- Severe sensory deficits interfering with the testing
Where it is running
1 location listed across 1 US state.
- University of Oklahoma Health Campus - Oklahoma City, Oklahoma, United States