40 Participants NeededMy employer runs this trial

Light Therapy for Mild Cognitive Impairment

(LTMC Trial)

PM
LG
Overseen ByLeslie Guthery
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Oklahoma
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

PM

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

Adequate hearing and visual acuity to participate in the examinations
English speaker
Clinical Dementia Rating (CDR) equal to 0.5 and/or Montreal Cognitive Assessment (MoCA) less than 26 and greater or equal to 19
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Exclusion Criteria

Major psychiatric disease including major depression not controlled on medications, alcohol or drug abuse
Patients currently using commercial brain stimulation or neuromodulation device as part of a research study
Any other medical condition or medication which, in the opinion of investigator, would render the patient too unstable to complete the study protocol
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What Are the Treatments Tested in This Trial?

How Is the Trial Designed?

2

Treatment groups

Active Control

Placebo Group

Group I: Active near-infrared light therapyActive Control1 Intervention
Group II: Sham near-infrared light therapyPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials
484
Recruited
95,900+