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Active, not recruiting Not applicable

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

NCT05845216 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2023-09-01
Last updated
2024-12-16

Condition(s) studied

Healthy Volunteers

Investigational drug(s) / intervention(s)

ACTIVE Transcranial photobiomodulation (tPBM)SHAM Transcranial photobiomodulation (tPBM)

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)

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
Accepted
Inclusion Criteria: * 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 Exclusion Criteria: * 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) * 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

Primary outcome measure(s)

  • Cerebral activations in response to a Finger Tapping motor task. — 24 minutes
    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

Trial sites (1)

FacilityCityRegionStatus
Clinatec Cea/Chuga Grenoble France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05845216 on ClinicalTrials.gov ↗ ← All trials in France