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Using Light Therapy for Mild Cognitive Impairment (LTMC)

10. juni 2026 opdateret af: University of Oklahoma

Neurovascular and Mitochondrial Mechanisms of Transcranial Photobiomodulation in Vascular Mild Cognitive Impairment

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.

Studieoversigt

Detaljeret beskrivelse

Cognitive impairment represents a major source of disability, with vascular pathologies playing a critical role in the development and progression of cognitive dysfunction. In particular, vascular cognitive impairment (VCI) is a common and clinically relevant contributor to cognitive decline in individuals with MCI. Despite substantial advances in understanding the underlying mechanisms of VCI, effective therapeutic interventions remain limited. Neurons require continuous energy supply, which is provided by the physiological process, called Neurovascular coupling (NVC), a dynamical redistribution of local cerebral blood flow to meet neuronal activity. NVC is essential to maintain optimal brain function. Evidence from our preclinical and clinical work, in line with findings from other research groups, increasingly implicates NVC dysregulation as a key mechanism underlying cognitive deficits in MCI, underscoring the need for targeted interventions aimed at restoring neurovascular function.

Transcranial photobiomodulation has emerged as a promising, non-invasive approach with the potential to support both neuronal and vascular health. By delivering near-infrared light to cortical tissue, tPBM has the potential to enhance mitochondrial activity, reduce oxidative stress, and improve cerebral hemodynamics. A growing body of literature demonstrates the beneficial effects of red and near-infrared light across a range of neurological, cardiovascular, and cerebrovascular conditions. However, the neurophysiological mechanisms underlying these effects remain insufficiently characterized in humans, and the therapeutic potential of tPBM has yet to be fully explored in clinical populations such as individuals with MCI. Optical imaging modalities, including near-infrared spectroscopy (NIRS), provide an opportunity to assess tPBM-induced changes in cerebral oxygenation and hemodynamics in real-world settings, thereby improving the feasibility and translational relevance of studies investigating cerebrovascular mechanisms in MCI. Further practical advantages of tPBM lie in its documented safe application, affordability, and simplicity of use; these factors support the utilization of tPBM in potential home-based interventions.

Recent studies have demonstrated a close association between cognitive performance and NVC responses both in healthy individuals and in patients with MCI. Neuronal activity-induced vasodilation is largely mediated by nitric oxide, whose bioavailability is enhanced by tPBM through its dissociation from cytochrome c oxidase. In addition, tPBM has been shown to exert anti-inflammatory effects within the brain, a mechanism that is particularly relevant given evidence of elevated neuroinflammatory processes in MCI. Despite these promising findings, clinical evidence directly examining the effects of tPBM on NVC remains limited. Existing studies have primarily focused on cognitive outcomes, with relatively little emphasis on underlying neurophysiological or hemodynamic changes and minimal integration of these measures. Addressing this gap, the present study aims to employ advanced multimodal neuroimaging techniques to investigate tPBM-induced modulation of NVC in individuals with MCI and to examine its relationship with cognitive performance.

Preclinical and early clinical studies indicate that tPBM enhances microvascular perfusion and tissue oxygenation while concurrently reducing neuroinflammation and oxidative stress. These complementary effects highlight tPBM as a multifaceted intervention capable of targeting both neural and vascular dysfunction. To date, tPBM has demonstrated a favorable safety profile across diverse populations, with transient and mild headache being the most commonly reported adverse effect. Its non-pharmacological nature and compatibility with existing therapeutic strategies further support its potential role in cognitive rehabilitation.

The significance of this project lies in its potential to advance a novel, non-invasive intervention for cognitive impairment in patients with MCI, as well as in its capacity to elucidate the neurovascular mechanisms through which tPBM exerts its effects. By clarifying how tPBM modulates NVC and related cognitive outcomes, this research will provide a foundation for future mechanism-driven and combination therapeutic approaches aimed at mitigating cognitive decline associated with MCI.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

40

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73104
        • Rekruttering
        • University of Oklahoma Health Campus
        • Kontakt:
        • Kontakt:
          • OUHSC Director Office of H.R.P.P.
          • Telefonnummer: +1 (405) 271 2045
        • Ledende efterforsker:
          • Peter Mukli, MD, PhD
        • Ledende efterforsker:
          • Calin Prodan, MD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 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.

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.

Andre navne:
  • Næsten-infrarød lysbehandling
  • tPBM
Sham-komparator: 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.

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.

Andre navne:
  • Næsten-infrarød lysbehandling
  • tPBM

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in cortical neurovascular coupling
Tidsramme: From baseline visit to the follow-up visit after completing a 12 week intervention protocol
Functional near infrared spectroscopy (fNIRS) and electroencephalography (EEG) will be performed during the cognitive n-back task. fNIRS approach generates data that represent a relative change in oxygenated and deoxygenated hemoglobin measured over the cortical brain tissues. EEG records electrical potential changes in the brain cortex. Neurovascular coupling will be evaluated as a change in oxy- and deoxy-hemoglobin between before and after treatment, normalized to change in EEG. The change in regression coefficient reflecting change in neurovascular coupling responses is a dimensionless measure.
From baseline visit to the follow-up visit after completing a 12 week intervention protocol

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in fluid cognition composite score
Tidsramme: From baseline visit to the follow-up visit after completing a 12 week intervention protocol.
NIH Toolbox will be used to assess fluid cognitive performance by calculating a composite score based on subscores from select tests targeting relevant domains, including attention, working memory, and executive function, as described in other pre-specified outcomes. Units of measure - score (from 0 to 200, the bigger the number, the better). Reported as a %change from baseline, before and after intervention.
From baseline visit to the follow-up visit after completing a 12 week intervention protocol.

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in neurovascular coupling in the middle cerebral arteries
Tidsramme: From baseline visit to the follow-up visit after completing a 12 week intervention protocol.
Transcranial Doppler sonography will be used to measure the change in the blood flow velocities during the cognitive n-back task between before and after treatment. Blood flow velocity will be expressed in cm/s. Task-induced increase in blood flow will be divided by resting state average, and the change in increase will be compared between baseline and follow-up visits and expressed as percentages.
From baseline visit to the follow-up visit after completing a 12 week intervention protocol.
Change in neurovascular coupling in the retinal vessels
Tidsramme: From baseline visit to the follow-up visit after completing a 12 week intervention protocol.
Flicker light-induced dilation of the retinal vessels (percentage increase over baseline diameter) will be measured in the right or left eye of each study participant using the Dynamic Vessel Analyzer (DVA, IMEDOS Systems, Jena, Germany). The change in retinal vessel diameters is tracked and reported as a %change from baseline, before and after treatment.
From baseline visit to the follow-up visit after completing a 12 week intervention protocol.
Change in the band-limited power of brain waves
Tidsramme: From baseline visit to the follow-up visit after completing a 12 week intervention protocol.
Band limited power in delta-, theta-, alpha-, beta- and gamma-bands during resting and task state measured by electroencephalography (EEG). Units of measure: μ V²/Hz.
From baseline visit to the follow-up visit after completing a 12 week intervention protocol.
Change in neuronal functional connectivity
Tidsramme: From baseline visit to the follow-up visit after completing a 12 week intervention protocol.
EEG will record cortical potential changes from multiple brain cortex regions simultaneously. Phase synchronization of these signals will be calculated to reveal neuronal functional connectivity, which is a dimensionless outcome measure.
From baseline visit to the follow-up visit after completing a 12 week intervention protocol.
Change in hemodynamic functional connectivity
Tidsramme: From baseline visit to the follow-up visit after completing a 12 week intervention protocol.
fNIRS will be used to record cerebral hemodynamics from multiple brain regions simultaneously. Correlation of simultaneously recorded cerebral hemodynamics will reveal hemodynamic functional connectivity, which is a dimensionless outcome measure.
From baseline visit to the follow-up visit after completing a 12 week intervention protocol.
Change in Attention
Tidsramme: From baseline visit to the follow-up visit after completing a 12 week intervention protocol.
The allocation of one's limited capacities to deal with an abundance of environmental stimulation will be measured in a combined "Flanker Inhibitory Control and Attention Test".Units of measure - score (from 0 to 10, bigger number is better). Reported as a %change from baseline, before and after treatment.
From baseline visit to the follow-up visit after completing a 12 week intervention protocol.
Change in Episodic Memory
Tidsramme: From baseline visit to the follow-up visit after completing a 12-week intervention protocol.
Cognitive processes involved in the acquisition, storage, and retrieval of new information will be measured using the "Picture Sequence Memory Test". Unit of measure - overall score (bigger number is better). Reported as a %change from baseline, before and after treatment.
From baseline visit to the follow-up visit after completing a 12-week intervention protocol.
Change in Working Memory
Tidsramme: From baseline visit to the follow-up visit after completing a 12-week intervention protocol.
The ability to store information until the amount of information to be stored exceeds one's capacity to hold that information will be measured using the "List Sorting Working Memory Test". Unit of measure - overall score (bigger number is better). Reported as a %change from baseline, before and after treatment.
From baseline visit to the follow-up visit after completing a 12-week intervention protocol.
Change in Executive Function
Tidsramme: From baseline visit to the follow-up visit after completing a 12-week intervention protocol.
The capacity to plan, organize, and monitor the executive of behaviors that are strategically directed in a goal-oriented manner will be measured using the "Dimensional Change Card Sort Test". Units of measure - score (from 0 to 10, the bigger the number, the better). Reported as a %change from baseline, before and after treatment.
From baseline visit to the follow-up visit after completing a 12-week intervention protocol.
Change in Processing Speed (non-verbal)
Tidsramme: From baseline visit to the follow-up visit after completing a 12-week intervention protocol.
The Pattern Comparison Processing Speed Test assesses the amount of information that can be processed within a certain unit of time. Items are simple to purely measure processing speed. Units of measure - score (from 0 to 130, bigger number is better). Reported as a %change from baseline, before and after treatment.
From baseline visit to the follow-up visit after completing a 12-week intervention protocol.
Change in Processing Speed and Sustained Attention
Tidsramme: From baseline visit to the follow-up visit after completing a 12-week intervention protocol.
The Oral Symbol Digit Test assesses the amount of information that can be processed within a certain unit of time. Participants are asked to orally call out the number that corresponds to each symbol in a provided master key table. Units of measure - score: number of symbols correctly identified within 120 seconds. Reported as a %change from baseline, before and after treatment.
From baseline visit to the follow-up visit after completing a 12-week intervention protocol.
Change in Extracellular vesicles of neuronal origin
Tidsramme: From baseline visit to the follow-up visit after completing a 12-week intervention protocol.
Extracellular vesicles of neuronal origin will be isolated from platelet poor plasma obtained from the participant, and their concentrations (count / microliter) will be determined reflecting the health of neurovascular unit.
From baseline visit to the follow-up visit after completing a 12-week intervention protocol.
Change in Extracellular vesicles of astrocytic origin
Tidsramme: From baseline visit to the follow-up visit after completing a 12-week intervention protocol.
Extracellular vesicles of astrocytic origin will be isolated from platelet poor plasma obtained from the participant, and their concentrations (count/microliter) will be determined reflecting the health of the neurovascular unit.
From baseline visit to the follow-up visit after completing a 12-week intervention protocol.
Change in Extracellular vesicles of cerebrovascular endothelial origin
Tidsramme: From baseline visit to the follow-up visit after completing a 12-week intervention protocol.
Extracellular vesicles of cerebrovascular endothelial origin will be isolated from platelet poor plasma obtained from the participant, and their concentrations (count/microliter) will be determined reflecting the health of the neurovascular unit.
From baseline visit to the follow-up visit after completing a 12-week intervention protocol.
Change in expression of pro-inflammatory cytokine IL-6
Tidsramme: From baseline visit to the follow-up visit after completing a 12-week intervention protocol.
To characterize anti-inflammatory activity of tPBM among study participants, commercially available human cerebromicrovascular endothelial cells (CMVEC) will be used and expression of interleukin-6 will be determined and expressed as cycle threshold, a dimensionless unit yielded by real-time quantitative PCR experiments.
From baseline visit to the follow-up visit after completing a 12-week intervention protocol.
Change in expression of pro-inflammatory cytokine TNF-alpha
Tidsramme: From baseline visit to the follow-up visit after completing a 12-week intervention protocol.
To characterize the anti-inflammatory activity of tPBM among study participants, commercially available human cerebromicrovascular endothelial cells (CMVEC) will be used, and expression of tumor necrosis factor alpha will be determined and expressed as cycle threshold, a dimensionless unit yielded by real-time quantitative PCR experiments.
From baseline visit to the follow-up visit after completing a 12-week intervention protocol.
Change in expression of anti-inflammatory cytokine IL-10
Tidsramme: From baseline visit to the follow-up visit after completing a 12-week intervention protocol.
To characterize the anti-inflammatory activity of tPBM among study participants, commercially available human cerebromicrovascular endothelial cells (CMVEC) will be used, and expression of interleukin-10 will be determined and expressed as cycle threshold, a dimensionless unit yielded by real-time quantitative PCR experiments.
From baseline visit to the follow-up visit after completing a 12-week intervention protocol.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Peter Mukli, MD, PhD, Department of Neurosurgery, University of Oklahoma Health Campus, Oklahoma, USA

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. oktober 2025

Primær færdiggørelse (Anslået)

31. december 2026

Studieafslutning (Anslået)

31. december 2026

Datoer for studieregistrering

Først indsendt

27. maj 2026

Først indsendt, der opfyldte QC-kriterier

10. juni 2026

Først opslået (Faktiske)

16. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

To ensure compliance, investigators will establish data management and sharing practices that align with NIH standards, including the timely submission of datasets to public repositories such as SenNet consortium, Figshare, SPARC portal and OpenNeuro. Invetigators will also publish findings in peer-reviewed journals registered in PubMed centrals to prevent unintentional duplication of research. All data generated in this project and the detailed description of the methods will be published in journals accessible through NIH databases.

IPD-delingstidsramme

01/01/2027-01/01/2032

IPD-delingsadgangskriterier

Deidentified IPD will be available from approved public repositories, such as OpenNeuro. Deidentified data will also be provided by the PI through direct contact via email, upon reasonable request.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Mild kognitiv svækkelse (MCI)

Abonner