Healthy VolunteersTIROCNCT05845216
Effect of Transcranial Near InfraRed Light on Cerebral Function in Young and Healthy Older Subjects: a FMRI Study (TIROC)
A study testing ACTIVE Transcranial photobiomodulation (tPBM) in people with Healthy Volunteers, run by University Hospital, Grenoble at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- ACTIVE Transcranial photobiomodulation (tPBM)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2023to 15 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Transcranial Near InfraRed Light on Cerebral Function in Young and Healthy Older Subjects: a Functional Magnetic Resonance Imaging (fMRI) Study (TIROC)
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.
Read the detailed description
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 :
- 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
- Healthy Volunteers
- Being tested
- ACTIVE Transcranial photobiomodulation (tPBM), SHAM Transcranial photobiomodulation (tPBM)
- Keywords
- Transcranial photobiomodulation, near InfraRed, fMRI, brain function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACTIVE Transcranial photobiomodulation (tPBM)Device
fMRI records before and after ACTIVE Transcranial photobiomodulation (tPBM)
SHAM Transcranial photobiomodulation (tPBM)Device
fMRI records before and after SHAM Transcranial photobiomodulation (tPBM)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Device: ACTIVE Transcranial photobiomodulation (tPBM) |
| SHAM tPBM | Sham comparator | one session of 24-tPBM with a sham device visually identical to the active device Receives: Device: SHAM Transcranial photobiomodulation (tPBM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 minutes
Secondary outcomes (2)
Performances in the Finger Tapping motor task
Performances in the Finger Tapping motor task (correct movement execution speed) before and after tPBM / Sham stimulation
Measured: 24 minutes
Functional connectivity (BOLD signal variations during the finger tapping task compared to rest state)
Functional connectivity measured by fMRI (BOLD signal variation during the Finger tapping task compared to rest state) before and after tPBM / sham stimulation
Measured: 24 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start1 Sep 2023
- Primary completion10 Dec 2024
- Study completion15 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Commissariat A L'energie Atomique, Fonds de Dotation Clinatec
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05845216
- Sponsor's protocol ID
- 38RC22.0227
- Acronym
- TIROC
- Status last verified
- Dec 2024
- First submitted
- 15 Mar 2023
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36927734El 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.
PubMed 31682952Dmochowski 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.
PubMed 34296085Hamblin 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.
PubMed 27752476Nizamutdinov 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.
PubMed 34221541
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transcranial Near InfraRed Light on Cerebral Function in Young and Healthy Older Subjects: a Functional Magnetic Resonance Imaging (fMRI) Study (TIROC)
- ClinicalTrials.gov ID
- NCT05845216
- Acronym / sponsor ID
- TIROC / 38RC22.0227
- Conditions
- Healthy Volunteers
- Keywords
- Transcranial photobiomodulation, near InfraRed, fMRI, brain function
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Commissariat A L'energie Atomique, Fonds de Dotation Clinatec
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 10 Dec 2024 (actual)
- Study completion
- 15 May 2026 (estimated)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 :
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| ACTIVE tPBM | Experimental | Device: ACTIVE Transcranial photobiomodulation (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) |
| SHAM tPBM | Sham comparator | Device: SHAM Transcranial photobiomodulation (tPBM)one session of 24-tPBM with a sham device visually identical to the active device |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACTIVE Transcranial photobiomodulation (tPBM)fMRI records before and after ACTIVE Transcranial photobiomodulation (tPBM) | Device | ACTIVE tPBM |
| SHAM Transcranial photobiomodulation (tPBM)fMRI records before and after SHAM Transcranial photobiomodulation (tPBM) | Device | SHAM tPBM |
Primary outcome
Cerebral activations in response to a Finger Tapping motor task.
Time frame: 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
2 secondary outcomes
Performances in the Finger Tapping motor task
Time frame: 24 minutes
Functional connectivity (BOLD signal variations during the finger tapping task compared to rest state)
Time frame: 24 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Background: PubMed 36927734Dole 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.
- Background: PubMed 31682952El 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.
- Background: PubMed 34296085Dmochowski 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.
- Background: PubMed 27752476Hamblin 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.
- Background: PubMed 34221541Nizamutdinov 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACTIVE Transcranial photobiomodulation (tPBM) in people with Healthy Volunteers, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral activations in response to a Finger Tapping motor task. (time frame: 24 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05845216, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024.