Effect of Transcranial Near InfraRed Light on Cerebral Function in Young and Healthy Older Subjects: a FMRI Study (TIROC)

NCT05845216 | Active Not Recruiting

• 1 other identifier: 38RC22.0227
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteers

Keywords

Transcranial photobiomodulation; near InfraRed; fMRI; brain function

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Performances in the Finger Tapping motor task

  24 minutes

• Functional connectivity (BOLD signal variations during the finger tapping task compared to rest state)

  24 minutes

Study Arms (2)

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)

Device: ACTIVE Transcranial photobiomodulation (tPBM)

SHAM tPBM

SHAM COMPARATOR

one session of 24-tPBM with a sham device visually identical to the active device

Device: SHAM Transcranial photobiomodulation (tPBM)

Interventions

ACTIVE Transcranial photobiomodulation (tPBM) DEVICE

fMRI records before and after ACTIVE Transcranial photobiomodulation (tPBM)

ACTIVE tPBM

SHAM Transcranial photobiomodulation (tPBM) DEVICE

fMRI records before and after SHAM Transcranial photobiomodulation (tPBM)

SHAM tPBM

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Man or woman
• 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

You may not qualify if:

• Known cognitive disorder, neurologic trouble, neurodegenerative disease or psychiatric illness,
• 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)
• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• Commissariat A L'energie Atomique: collaborator
• Fonds de Dotation Clinatec: collaborator

Study Sites (1)

Clinatec Cea/Chuga

Grenoble, 38054, France

Location

Related Publications (5)

• 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.

  PMID: 36927734 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.

  PMID: 31682952 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.

  PMID: 34296085 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.

  PMID: 27752476 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.

  PMID: 34221541 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 15, 2023
• First Posted: May 6, 2023
• Study Start: September 1, 2023
• Primary Completion: December 10, 2024
• Study Completion: May 15, 2026
• Last Updated: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)