Recruiting

tPBM

Sponsor:

University of Oklahoma

Code:

NCT07651787

Conditions

Mild Cognitive Impairment (MCI)

Amyloid Pathology

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

Interventions

Active Vielight Neuro RX-Duo device -Active transcranial photobiomodulation

Sham Vielight Neuro RX-Duo device -Sham transcranial photobiomodulation

Study Details

Brief 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.

Conditions

Mild Cognitive Impairment (MCI)

Amyloid Pathology

Study ID

NCT07651787

Start date

Oct 1, 2025

Status verified date

Jun, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Active Vielight Neuro RX-Duo device -Active transcranial photobiomodulation

The active Vielight Neuro RX-Duo devices (© Vielight Inc.) will be used to transmit pulsed near-infrared (NIR) energy through the cranium. The device emits NIR photons at an 810-nm wavelength, generating \~250 mW/cm² of pulsed NIR power modulated at 10 and 40 Hz frequencies (Alpha and Gamma modes). The six NIR light sources are positioned along the midline over the frontal, parietal, and occipital cortices, bilaterally over the temporal cortices, and intranasally. Because of their portable design, Vielight Neuro RX-Duo instruments can be used in the laboratory, at the bedside, or in the participant's home.

Active photobiomodulation sessions will last 20 minutes and will be administered in a laboratory, home, or office setting, depending on participant preference. TPBM will be delivered once per day, six times per week, for 12 weeks. Participants will complete an adverse-events questionnaire after each session.

Sham Vielight Neuro RX-Duo device -Sham transcranial photobiomodulation

Sham Vielight Neuro RX-Duo devices (© Vielight Inc.) will be used. These devices are identical in appearance to the active devices; however, they do not emit near-infrared (NIR) light at an 810-nm wavelength. The six light sources are positioned along the midline over the frontal, parietal, and occipital cortices; bilaterally over the temporal cortices; and intranasally. Because of their portable design, Vielight Neuro RX-Duo instruments can be used in the laboratory, at the bedside, or in the participant's home.

Sham photobiomodulation sessions will last 20 minutes and will be administered in a laboratory, home, or office setting, depending on participant preference. TPBM will be delivered once per day, six times per week, for 12 weeks. Participants will complete an adverse-events questionnaire after each session.

Primary outcome measure

  • Change in cortical neurovascular coupling [ Time Frame: From baseline visit to the follow-up visit after completing a 12 week intervention protocol ]

Central Contacts and Locations

Central contacts

Peter Mukli

+1 (405) 271-8001peter-mukli@ou.edu

Leslie Guthery

+1 (405) 271-4113leslie-guthery@ou.edu

Locations

University of Oklahoma Health Campus

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Leslie Guthery, MS

405-271-4113leslie-guthery@ou.edu

OUHSC Director Office of H.R.P.P.

+1 (405) 271 2045

Principal Investigator:

Peter Mukli, MD, PhD

More Information

Sponsor

University of Oklahoma

Last update posted

Jun 16, 2026

Last verified

Jun, 2026

Keywords

  • Cognition
  • Neurovascular Coupling Mechanism and Cognitive Function
  • Neurovascular Control
  • Brain Aging
  • Brain Activity
  • Mild Congitive Impairment (MCI)
  • Amyloid
  • Transcranial photobiomodulation
  • Near-infrared spectroscopy
  • Cerebral hemodynamics
  • Near-infrared light therapy
  • NIH Toolbox Cognition Battery
  • Electroencephalography
  • Amyloid-positive mild cognitive impairment
  • Amyloid-negative mild cognitive impairment
  • Extracellular vesicles
  • Neuroinflammation
  • Proinflammatory cytokines
  • Home-based neuromodulation
  • Non-invasive brain stimulation
  • Sham-controlled clinical trial
  • Randomized clinical trial
  • photobiomodulation therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Oklahoma on 2026-06-16.