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Using Light Therapy for Mild Cognitive Impairment (LTMC)

2026년 6월 10일 업데이트: 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.

연구 개요

상세 설명

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.

연구 유형

중재적

등록 (추정된)

40

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

    • Oklahoma
      • Oklahoma City, Oklahoma, 미국, 73104
        • 모병
        • University of Oklahoma Health Campus
        • 연락하다:
        • 연락하다:
          • OUHSC Director Office of H.R.P.P.
          • 전화번호: +1 (405) 271 2045
        • 수석 연구원:
          • Peter Mukli, MD, PhD
        • 수석 연구원:
          • Calin Prodan, MD

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: 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.

다른 이름들:
  • 근적외선 조명 요법
  • tPBM
가짜 비교기: 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.

다른 이름들:
  • 근적외선 조명 요법
  • tPBM

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in cortical neurovascular coupling
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Change in fluid cognition composite score
기간: 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.

기타 결과 측정

결과 측정
측정값 설명
기간
Change in neurovascular coupling in the middle cerebral arteries
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Peter Mukli, MD, PhD, Department of Neurosurgery, University of Oklahoma Health Campus, Oklahoma, USA

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 10월 1일

기본 완료 (추정된)

2026년 12월 31일

연구 완료 (추정된)

2026년 12월 31일

연구 등록 날짜

최초 제출

2026년 5월 27일

QC 기준을 충족하는 최초 제출

2026년 6월 10일

처음 게시됨 (실제)

2026년 6월 16일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 16일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 10일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

IPD 계획 설명

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 공유 기간

01/01/2027-01/01/2032

IPD 공유 액세스 기준

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 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

미국에서 제조되어 미국에서 수출되는 제품

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

Active Vielight Neuro RX-Duo device -Active transcranial photobiomodulation에 대한 임상 시험

구독하다