Effect of Transcranial Near InfraRed Light on Cerebral Function in Young and Healthy Older Subjects: a FMRI Study (TIROC)
NCT ID: NCT05845216
Last Updated: 2024-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
64 participants
INTERVENTIONAL
2023-09-01
2026-05-15
Brief Summary
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The hypothesis of the investigators is that tPBM improves brain function in participants who will be treated using the active device in comparison with those treated with the sham device and that this effect should will be more pronounced in the older subjects.
Detailed Description
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At the cellular level, it is thought that the mechanism mainly relies on the activation of the cytochrome C oxidase and/or interfacial nanowater, two photoacceptors located within the mitochondria that absorb red and near infrared photons. The interaction between the photons and the photoacceptor results in a cascade of secondary events, activating the respiratory chain and increasing Adenosine TriPhosphate (ATP) synthesis, the main source of energy in the cell.
In humans, an increasing number of studies have reported an improvement of cognitive functions after one or several tPBM sessions in patients suffering Alzheimer's or Parkinson's disease, or in cases of stroke. Recently, some EEG and fMRI studies on healthy subjects, young and/or old, have also reported a modification of neuronal activation patterns at rest or during the performance of a cognitive task.
Regarding tPBM, this is a non-pharmacological and non-surgical treatment, for which no adverse effects have been reported. Further, the FDA has already approved the use of several PBM devices for therapeutic use in humans, for example, the treatment of pain, inflammation or dermal conditions.
Those preliminary results in humans are thus very encouraging. However, the precise mechanism of action remains to be better characterised, and further studies are required to better define its effects on the human brain and its indications for a therapeutic use. Moreover the extent tPBM influence on the brain of the elderly is still very unclear. In the present study, the investigators aim to evaluate brain function before and after a tPBM session, during the realisation of a motor task or at rest, while comparing a group of young and elderly subjects.
The working hypotheses of the investigators are as follows :
* tPBM will improve motor performances and brain function of all subjects, and to a greater extent that of the older subjects
* tPBM will change brain activity, reorganising large scale neuronal networks at rest.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
SINGLE
Study Groups
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ACTIVE tPBM
one session of 24-min tPBM with the active device (tPBM helmet with 80 Light-Emitting Diodes (LEDs) emitting red and near-infrared light at 670 - 810nm)
ACTIVE Transcranial photobiomodulation (tPBM)
fMRI records before and after ACTIVE Transcranial photobiomodulation (tPBM)
SHAM tPBM
one session of 24-tPBM with a sham device visually identical to the active device
SHAM Transcranial photobiomodulation (tPBM)
fMRI records before and after SHAM Transcranial photobiomodulation (tPBM)
Interventions
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ACTIVE Transcranial photobiomodulation (tPBM)
fMRI records before and after ACTIVE Transcranial photobiomodulation (tPBM)
SHAM Transcranial photobiomodulation (tPBM)
fMRI records before and after SHAM Transcranial photobiomodulation (tPBM)
Eligibility Criteria
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Inclusion Criteria
* Aged 18 to 40 (young group), or 60 to 85 (elderly)
* Right-handed (Edinburgh score for hand laterality \>70%)
* No taking psychoactive or anti-depressants medicine
* Normal or corrected vision
* Having expressed their consent to the research
* Affiliated to a social security scheme
* Registered in the national file of people lend themselves to biomedical research
Exclusion Criteria
* Motor disorder able to impair the task management
* Contraindication for MRI (metallic implant, non-removable piercing, pace-maker, metallic prosthesis, claustrophobia , …)
* Montreal Cognitive Assessment (MoCA) score \<26
* People referred to in Articles L1121-5 to L1121-8 of the Public Health Code(corresponds to all protected persons: pregnant, parturient or breastfeeding women, persons deprived of liberty by judicial or administrative decision, persons subject of psychiatric care, minors, and persons subject to a legal protection measure: guardianship, curators or safeguard of justice)
* Persons in period of exclusion from another clinical investigation
* Subjects participating in another clinic investigation,
* Subjects who would receive more than 4500 euros in compensation due to his participation in other biomedical research in the 12 months preceding this study
18 Years
85 Years
ALL
Yes
Sponsors
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Commissariat A L'energie Atomique
OTHER_GOV
Fonds de Dotation Clinatec
UNKNOWN
University Hospital, Grenoble
OTHER
Responsible Party
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Locations
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Clinatec Cea/Chuga
Grenoble, , France
Countries
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References
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Dole M, Auboiroux V, Langar L, Mitrofanis J. A systematic review of the effects of transcranial photobiomodulation on brain activity in humans. Rev Neurosci. 2023 Mar 17;34(6):671-693. doi: 10.1515/revneuro-2023-0003. Print 2023 Aug 28.
El Khoury H, Mitrofanis J, Henderson LA. Exploring the Effects of Near Infrared Light on Resting and Evoked Brain Activity in Humans Using Magnetic Resonance Imaging. Neuroscience. 2019 Dec 1;422:161-171. doi: 10.1016/j.neuroscience.2019.10.037. Epub 2019 Nov 1.
Dmochowski GM, Shereen AD, Berisha D, Dmochowski JP. Near-Infrared Light Increases Functional Connectivity with a Non-thermal Mechanism. Cereb Cortex Commun. 2020 Mar 19;1(1):tgaa004. doi: 10.1093/texcom/tgaa004. eCollection 2020.
Hamblin MR. Shining light on the head: Photobiomodulation for brain disorders. BBA Clin. 2016 Oct 1;6:113-124. doi: 10.1016/j.bbacli.2016.09.002. eCollection 2016 Dec.
Nizamutdinov D, Qi X, Berman MH, Dougal G, Dayawansa S, Wu E, Yi SS, Stevens AB, Huang JH. Transcranial Near Infrared Light Stimulations Improve Cognition in Patients with Dementia. Aging Dis. 2021 Jul 1;12(4):954-963. doi: 10.14336/AD.2021.0229. eCollection 2021 Jul.
Other Identifiers
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38RC22.0227
Identifier Type: -
Identifier Source: org_study_id