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| Name | Class |
|---|---|
| Commissariat A L'energie Atomique | OTHER_GOV |
| Fonds de Dotation Clinatec | UNKNOWN |
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Numerous studies have shown that the extra-cranial application of near infrared light (λ=600-1000nm) (also called transcranial photobiomodulation or tPBM), has a positive impact on brain function in both humans and experimental animal models and a neuroprotective effect in animal models. Several of these studies have reported that tPBM could impart more beneficial effects in aged or diseased brains. The primary objective of this study is to use fMRI to compare the cerebral activations in response to a finger tapping motor task, before and after 24min of tPBM versus sham stimulation, in old and young healthy human subjects.
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.
Many studies have shown that the extra-cranial application of light in the red and near infrared range (λ=600-1000nm), also called transcranial PhotoBioModulation (tPBM), could have a neuroprotective effect and a positive impact on brain function in the mammalian brain.
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 :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACTIVE tPBM | Experimental | 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) |
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| SHAM tPBM | Sham Comparator | one session of 24-tPBM with a sham device visually identical to the active device |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACTIVE Transcranial photobiomodulation (tPBM) | Device | fMRI records before and after ACTIVE Transcranial photobiomodulation (tPBM) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cerebral activations in response to a Finger Tapping motor task. | Cerebral activation measured by fMRI (BOLD signal change) in response to a finger tapping motor tap (contrasted against a resting baseline), before and after tPBM/Sham stimulation | 24 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Performances in the Finger Tapping motor task | Performances in the Finger Tapping motor task (correct movement execution speed) before and after tPBM / Sham stimulation | 24 minutes |
| Functional connectivity (BOLD signal variations during the finger tapping task compared to rest state) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinatec Cea/Chuga | Grenoble | 38054 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36927734 | Background | 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. | |
| 31682952 | Background | 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. |
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The Primary Purpose of this clinical trial is to test a prototype device for feasibility and not health outcomes. This study is conducted to confirm the design and operating specifications of a device before beginning a full clinical trial.
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| SHAM Transcranial photobiomodulation (tPBM) | Device | fMRI records before and after SHAM Transcranial photobiomodulation (tPBM) |
|
Functional connectivity measured by fMRI (BOLD signal variation during the Finger tapping task compared to rest state) before and after tPBM / sham stimulation |
| 24 minutes |
| 34296085 | Background | 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. |
| 27752476 | Background | 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. |
| 34221541 | Background | 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. |