- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07793604
Increasing Mitochondrial Respiration as a Novel Mechanism for Cognitive Augmentation (MITOCOG)
2026년 8월 26일 업데이트: Francisco Gonzalez-Lima, PhD
The purpose of this study is to investigate the effects of increasing brain energy on cognition.
The hypothesis is that by using a special kind of light, in combination with a nutritional supplement, it may be possible to increase energy production in the brain, which may lead to improvements in cognition.
연구 개요
상태
아직 모집하지 않음
상세 설명
The Gonzalez-Lima Laboratory at the University of Texas at Austin is recruiting participants for a research study.
The study examines whether a combined treatment can improve cognitive function.
The treatment includes transcranial photobiomodulation (tPBM), a form of light therapy applied to the forehead, along with a dietary supplement.
The treatment targets an enzyme called cytochrome-c-oxidase, which plays a key role in how the mitochondria inside brain cells use oxygen to produce energy.
As people age, this process often becomes less efficient, contributing to cognitive decline seen in normal aging and in neurodegenerative diseases.
The hypothesis is that improving mitochondrial function and cytochrome-c-oxidase activity will boost neuronal energy production and reduce oxidative stress, ultimately enhancing cognitive performance.
Previous studies from the Gonzalez-Lima Lab found that applying tPBM to the prefrontal cortex improves brain metabolic activity and enhances cognitive functions such as attention, memory, and executive function.
The dietary supplement provides an alternative energy source derived from ketones, which mitochondria can use for oxygen metabolism.
This may help bypass the impaired glucose metabolism often seen in aging brains, potentially leading to further cognitive improvements.
This study will investigate the cognitive effects of this combined treatment in adults ages 18 to 85.
During the first visit to the lab, participants will complete informed consent, health questionnaires, and cognitive assessments, and wear sensors on the head which monitor brain activity.
They will also be trained to use a headset device which uses light-emitting diodes (LEDs) to deliver light to the forehead.
They will be given daily supplements and instructed on how to maintain a daily log for at-home treatments.
Then, for the next two months, participants will complete the daily protocol at home.
Weekly check-ins will monitor progress throughout this period.
After two months, participants will return to repeat the assessments from the first visit and return their study materials.
Participants will receive $200 upon completing the study, and parking expenses will be reimbursed for each visit.
Briefly, one aim will be to map the relationship between baseline prefrontal functional connectivity and dimensional performance in cognitive control and affective processing.
Another aim will be to evaluate mechanistic efficacy of chronic tPBM in engaging prefrontal circuits and restoring task-based behavioral performance.
A final aim is to model the longitudinal relationship between prefrontal circuit health and real-world sleep, circadian stability, and neuroendocrine regulation.
By focusing on target-driven biobehavioral mechanisms, this study aims to identify novel therapeutic targets and establish scalable biomarker pipelines.
연구 유형
중재적
등록 (추정된)
180
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Francisco Gonzalez-Lima
- 전화번호: (512) 703-1804
- 이메일: utcognitivestudy@gmail.com
연구 장소
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Texas
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Austin, Texas, 미국, 78712
- The University of Texas at Austin
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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
예
설명
Inclusion Criteria:
- Age: 18-85 years old
- No uncorrected visual, auditory, or motor impairments that would interfere with performing cognitive tasks
Exclusion Criteria:
- Transcranial photobiomodulation in the last six weeks
- Diabetes
- Pregnancy or plans to become pregnant
- Breastfeeding or plans to breastfeed
- Major depressive disorder
- Psychotic disorders
- Suicidal ideation within the past 6 months
- Plans for serious medical procedures in the next 3 months
- Serious hepatic or liver-related conditions
- History of neurotrauma (e.g., brain lesions or traumatic brain injury)
- Presently on a ketogenic diet
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 요인 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: Arm 1: active tPBM, active MCT dietary supplementation
Participants in this arm will receive active transcranial photobiomodulation to the forehead, targeting prefrontal cortex, and active dietary supplementation with refined coconut oil to provide ketones.
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Infrared light delivered to the forehead, administered with a headset using light-emitting diodes (LEDs)
Commercially-available food-grade refined coconut oil for ketogenic dietary supplementation
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가짜 비교기: Arm 2: sham tPBM, sham dietary supplementation
Participants in this arm will undergo the same procedures as the active group, but with sham photobiomodulation (5% of experimental light emitted by the device) and sham dietary supplementation with sunflower oil (comparable caloric value without ketone production).
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Identical procedure as active group, but with 5% of light emitted by the device.
Identical appearance and administration as active dietary supplementation, but with commercially-available food-grade sunflower oil (comparable caloric value without ketone production).
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Cognitive assessment: Montreal Cognitive Assessment (MoCA)
기간: The MoCA will be administered: 1. Pre-treatment (during Visit 1); 2. Post-treatment (Visit 2, two months later)
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The Montreal Cognitive Assessment is a standard questionnaire which was developed to test for cognitive impairment.
The MoCA assesses a variety of cognitive functions including executive function, memory, attention, and verbal fluency.
Minimum=0; Maximum=30; low score=more impairment.
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The MoCA will be administered: 1. Pre-treatment (during Visit 1); 2. Post-treatment (Visit 2, two months later)
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Cognitive assessment: Trail-Making Test
기간: The TMT will be administered: 1. Pre-treatment (during Visit 1); 2. Post-treatment (Visit 2, two months later)
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The trail-making test (TMT) is a paper-and-pencil "connect-the-dots" task which is used to test visual attention and cognitive flexibility.
Completion time (seconds) and number of errors are recorded.
Faster time and lower errors=better performance.
Maximum time alloted=300 seconds.
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The TMT will be administered: 1. Pre-treatment (during Visit 1); 2. Post-treatment (Visit 2, two months later)
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Brain metabolism assessment: Functional Near-Infrared Spectroscopy (fNIRS)
기간: The fNIRS procedure will be administered: 1. Pre-treatment (during Visit 1); 2. Post-treatment (Visit 2, two months later)
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Participants wear a device on the head which assesses brain metabolism non-invasively using functional near-infrared spectroscopy.
The device records changes in the concentrations of oxygenated hemoglobin in the prefrontal cortex of the brain.
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The fNIRS procedure will be administered: 1. Pre-treatment (during Visit 1); 2. Post-treatment (Visit 2, two months later)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Cognitive assessment: 2-Back Task
기간: The 2-back task will be administered: 1. Pre-treatment (during Visit 1); 2. Post-treatment (Visit 2, two months later)
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The 2-back task is a standard computer-based test that assesses attention and short-term memory, in which participants remember a series of letters presented onscreen.
Accuracy (number of errors) and speed (reaction time in seconds) are recorded.
Faster time and lower errors=better performance.
Duration: 5 minutes.
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The 2-back task will be administered: 1. Pre-treatment (during Visit 1); 2. Post-treatment (Visit 2, two months later)
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Cognitive assessment: Delayed Match-to-Sample Task (DMS)
기간: The DMS will be administered: 1. Pre-treatment (during Visit 1); 2. Post-treatment (Visit 2, two months later)
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The DMS is a standard computer-based test that assesses visuospatial memory and attention, in which participants remember a grid pattern through a delay and then identify the correct match.
Number of correct responses and reaction time in seconds are measured.
Faster time and lower errors=better performance.
Duration=5 minutes.
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The DMS will be administered: 1. Pre-treatment (during Visit 1); 2. Post-treatment (Visit 2, two months later)
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Weekly check-in
기간: Once per week during treatment
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Open response, verification of compliance of treatment
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Once per week during treatment
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Follow-up
기간: One month after Visit 2
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Open response of any long-term effects of treatment
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One month after Visit 2
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
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 (추정된)
2026년 10월 1일
기본 완료 (추정된)
2029년 12월 1일
연구 완료 (추정된)
2030년 5월 1일
연구 등록 날짜
최초 제출
2026년 8월 19일
QC 기준을 충족하는 최초 제출
2026년 8월 26일
처음 게시됨 (실제)
2026년 8월 28일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 8월 28일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 26일
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 연구와 관련된 용어
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
What data will be shared?
Individual participant data that underlie the results reported in this study, after deidentification (text, tables, figures, and appendices).
A data dictionary, including a description of the variables and types of data, collected for each individual, will be provided.
This data will include anonymized individual participant demographic information and all outcome variables (cognitive task data, spectroscopy data).
IPD 공유 기간
Beginning 9 months and ending 36 months following article publication.
IPD 공유 액세스 기준
The raw data will be made available by the researchers upon reasonable request by any qualified doctoral researcher (PhD, MD).
They will be granted access by contacting the corresponding author/principal investigator (F.
Gonzalez-Lima, utcognitivestudy@gmail.com).
It will be made available to qualified researchers whose proposed use of the data has been approved by an independent review committee (Institutional Review Board) identified for the purpose of individual participant data meta-analysis.
Proposals may be submitted up to 36 months following article publication.
After 36 months, the data will be available in our University's shared network drive, but without investigator support other than deposited metadata.
IPD 공유 지원 정보 유형
- 연구_프로토콜
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
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. .