HealthyMoveNIRSNCT05789121
Study of Cerebral Activation by fNIRS During Gait With Different Rhythmic Auditory Stimulations in Healthy Subjects
An observational study of Healthy, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
Trial summary
The purpose of this study is to investigate the cerebral activation in healthy subjects in 4 conditions of gait : Gait at preferred cadence without auditory stimulation (Gait1) Gait with low tempo rhythmic auditory stimulation by music (RAS-Slow). The beat rate of the music was 68.5 per minute for all participants. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- walking 25 m in 4 different conditions
- Type of treatment
- Medical device
- How many people
- 29 participants
- Where
- 1 siteFrance
- Study dates
- 14 Mar 2023to 24 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy subjects aged between 18 and 40 years
Who may be able to join
- Age 18 to 40 years old.
- No known neurological disease
- Benefiting from a social security coverage.
- Sufficient knowledge of the French language to understand the instructions
Who cannot join
- Person under tutorship or curatorship
- Known allergy to components of the fNIRS device: neoprene
- History of neurological disease
- History of rheumatological disease affecting walking
- Pregnant or breastfeeding women
- Subjects opposed to participating in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Rhythmic Auditory Stimulation (RAS) During Gait on Cortical Activation: A Functional Near-infrared Red Spectroscopy Neuroimaging Study (fNIRS)
The purpose of this study is to investigate the cerebral activation in healthy subjects in 4 conditions of gait :
- Gait at preferred cadence without auditory stimulation (Gait1)
- Gait with low tempo rhythmic auditory stimulation by music (RAS-Slow). The beat rate of the music was 68.5 per minute for all participants.
- Gait with fast tempo synchronous rhythmic auditory stimulation by music (RAS-Fast). The beat rate of the music was set to 10% above each patient's preferred gait cadence . The preferred cadence was considered as the mean of the 6 trials during Gait 1.
- Gait without auditory stimulation (Gait2) The investigators goal is to compare cerebral activation and gait parameters during the 4 different tasks using fNIRS.
Read the detailed description
Gait and balance impairments caused by neurological disorders affect many people around the world and impact on independent living and quality of life. Gait rehabilitation is therefore highly important for individuals with neurological diseases. In recent years, rehabilitation strategies were carried out considering new technological devices and paradigms have been developed to increase the effectiveness of rehabilitation. Brain and clinical research have provided a new understanding of the capabilities of music to engage and shape motor functions to support brain recovery processes. Humans possess an ability to perceive and synchronize movements to the beating music. In context of motor rehabilitation, musical rhythm entrains movement in patients with neurological impairment, opening new frontiers for using rhythm and music to prime the motor system and favour improvement of deficiency consequences. Rhythmic auditory stimulation (RAS) is a gait rehabilitation method in which patients synchronize foot steps to a metronome or musical beats. Typically, rhythmic cues are matched to the individual's preferred cadence and, once the movement is entrained to the external cues, the rhythm is gradually increased by 5-10% over baseline. However, little is known about the neural correlates of gait during RAS.
fNIRS (functional Near Infra Red Spectroscopy) is a functional method that allows to study the cerebral cortex changes during different tasks (like fMRI). This technique therefore makes it possible to study brain activation under more ecological conditions than fMRI and are therefore particularly suitable for exploring rehabilitation techniques.
This research aims to study and compare in healthy subjects, using, the brain regions involved in 4 conditions of gait without and with rhythmic auditory stimulations.
The protocol has 4 conditions :
- Gait at preferred cadence without auditory stimulation (Gait1)
- Gait with low tempo rhythmic auditory stimulation by music (RAS-Slow). The beat rate of the music was 68.5 per minute for all participants.
- Gait with fast tempo synchronous rhythmic auditory stimulation by music (RAS-Fast). The beat rate of the music was set to 10% above each patient's preferred gait cadence . The preferred cadence was considered as the mean of the 6 trials during Gait 1.
- Gait without auditory stimulation (Gait2) The investigators choosed a fixed order rather a randomized one, because the use of auditory stimulation may interferes with subsequent tasks. The comfortable gait was proposed as first and last conditions to check this aftereffect.
The fNIRS will used the Brite MKII apparatus. Gait parameters were recorded by FeetMe(R) Monitor (insole version FTM-DK, Atmel firmware version 2.3.10, Nordic firmware version 6.3.15).
Four gait parameters, including speed, cadence, stride length and double support time were analyzed. Gait speed is defined as the walking distance in a second (in cm/s), cadence as the number of steps within a minute walk (in steps/min). Stride length indicates the distance (in cm) from initial contact of one foot to subsequent contact of same foot. Double support time occurs when both feet are in contact with the ground simultaneously, it is normalized to stride time and expressed in % Gait Cycle (%). These 4 parameters are the most commonly used when studying the effect of SAR on gait.
- Conditions
- Healthy
- Being tested
- walking 25 m in 4 different conditions
- Keywords
- Rhythmic auditory stimulation, Gait, Near infrared spectroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
walking 25 m in 4 different conditionsDevice
The protocol consisted of walking 25 m in 4 different conditions in the following order:
Gait1, RAS-Slow, RAS-fast, Gait2.
- Gait 1 : preferred cadence without auditory stimulation
- RAS-Slow : Gait with low tempo rhythmic auditory stimulation by music (68.5 per minute).
- RAS-Fast : Gait with fast tempo (10% above each Gait1 cadence).
- Gait2 : preferred cadence without auditory stimulation
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | 30 healthy subject aged between 18 and 40. Receives: Device: walking 25 m in 4 different conditions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in the concentration of oxyhemoglobin during the task
Measured: Day 0
Mean change in the concentration of deoxyhemoglobin during the task
Measured: Day 0
Secondary outcomes (4)
Walking speed
Measured: Day 0
Number of steps within a minute walk (in steps/min)
Number of steps within a minute walk (in steps/min)
Measured: Day 0
stride length
Measured: Day 0
double support time
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2023
- Study start14 Mar 2023
- Primary completion24 Mar 2023
- Study completion24 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Auzou PASCAL, Dr, Principal investigator, CHR d'Orleans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05789121
- Sponsor's protocol ID
- CHRO-2022-09
- Acronym
- MoveNIRS
- Status last verified
- Mar 2023
- First submitted
- 10 Mar 2023
- Last updated
- 31 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Altenmuller E, Schlaug G. Apollo's gift: new aspects of neurologic music therapy. Prog Brain Res. 2015;217:237-52. doi: 10.1016/bs.pbr.2014.11.029. Epub 2015 Feb 11.
PubMed 25725918Bonnal J, Monnet F, Le BT, Pila O, Grosmaire AG, Ozsancak C, Duret C, Auzou P. Relation between Cortical Activation and Effort during Robot-Mediated Walking in Healthy People: A Functional Near-Infrared Spectroscopy Neuroimaging Study (fNIRS). Sensors (Basel). 2022 Jul 25;22(15):5542. doi: 10.3390/s22155542.
PubMed 35898041Braunlich K, Seger CA, Jentink KG, Buard I, Kluger BM, Thaut MH. Rhythmic auditory cues shape neural network recruitment in Parkinson's disease during repetitive motor behavior. Eur J Neurosci. 2019 Mar;49(6):849-858. doi: 10.1111/ejn.14227. Epub 2018 Dec 3.
PubMed 30375083Farid L, Jacobs D, Do Santos J, Simon O, Gracies JM, Hutin E. FeetMe(R) Monitor-connected insoles are a valid and reliable alternative for the evaluation of gait speed after stroke. Top Stroke Rehabil. 2021 Mar;28(2):127-134. doi: 10.1080/10749357.2020.1792717. Epub 2020 Jul 13.
PubMed 32654627Koshimori Y, Thaut MH. Future perspectives on neural mechanisms underlying rhythm and music based neurorehabilitation in Parkinson's disease. Ageing Res Rev. 2018 Nov;47:133-139. doi: 10.1016/j.arr.2018.07.001. Epub 2018 Jul 10.
PubMed 30005957Merchant H, Grahn J, Trainor L, Rohrmeier M, Fitch WT. Finding the beat: a neural perspective across humans and non-human primates. Philos Trans R Soc Lond B Biol Sci. 2015 Mar 19;370(1664):20140093. doi: 10.1098/rstb.2014.0093.
PubMed 25646516Thaut MH. The discovery of human auditory-motor entrainment and its role in the development of neurologic music therapy. Prog Brain Res. 2015;217:253-66. doi: 10.1016/bs.pbr.2014.11.030. Epub 2015 Feb 2.
PubMed 25725919
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Rhythmic Auditory Stimulation (RAS) During Gait on Cortical Activation: A Functional Near-infrared Red Spectroscopy Neuroimaging Study (fNIRS)
- ClinicalTrials.gov ID
- NCT05789121
- Acronym / sponsor ID
- MoveNIRS / CHRO-2022-09
- Conditions
- Healthy
- Keywords
- Rhythmic auditory stimulation, Gait, Near infrared spectroscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional d'OrléansUniversity, hospital or other
- Study start
- 14 Mar 2023 (actual)
- Primary completion
- 24 Mar 2023 (actual)
- Study completion
- 24 Mar 2023 (actual)
- First posted
- 29 Mar 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.
The purpose of this study is to investigate the cerebral activation in healthy subjects in 4 conditions of gait :
- Gait at preferred cadence without auditory stimulation (Gait1)
- Gait with low tempo rhythmic auditory stimulation by music (RAS-Slow). The beat rate of the music was 68.5 per minute for all participants.
- Gait with fast tempo synchronous rhythmic auditory stimulation by music (RAS-Fast). The beat rate of the music was set to 10% above each patient's preferred gait cadence . The preferred cadence was considered as the mean of the 6 trials during Gait 1.
- Gait without auditory stimulation (Gait2) The investigators goal is to compare cerebral activation and gait parameters during the 4 different tasks using fNIRS.
Detailed description
Gait and balance impairments caused by neurological disorders affect many people around the world and impact on independent living and quality of life. Gait rehabilitation is therefore highly important for individuals with neurological diseases. In recent years, rehabilitation strategies were carried out considering new technological devices and paradigms have been developed to increase the effectiveness of rehabilitation. Brain and clinical research have provided a new understanding of the capabilities of music to engage and shape motor functions to support brain recovery processes. Humans possess an ability to perceive and synchronize movements to the beating music. In context of motor rehabilitation, musical rhythm entrains movement in patients with neurological impairment, opening new frontiers for using rhythm and music to prime the motor system and favour improvement of deficiency consequences. Rhythmic auditory stimulation (RAS) is a gait rehabilitation method in which patients synchronize foot steps to a metronome or musical beats. Typically, rhythmic cues are matched to the individual's preferred cadence and, once the movement is entrained to the external cues, the rhythm is gradually increased by 5-10% over baseline. However, little is known about the neural correlates of gait during RAS.
fNIRS (functional Near Infra Red Spectroscopy) is a functional method that allows to study the cerebral cortex changes during different tasks (like fMRI). This technique therefore makes it possible to study brain activation under more ecological conditions than fMRI and are therefore particularly suitable for exploring rehabilitation techniques.
This research aims to study and compare in healthy subjects, using, the brain regions involved in 4 conditions of gait without and with rhythmic auditory stimulations.
The protocol has 4 conditions :
- Gait at preferred cadence without auditory stimulation (Gait1)
- Gait with low tempo rhythmic auditory stimulation by music (RAS-Slow). The beat rate of the music was 68.5 per minute for all participants.
- Gait with fast tempo synchronous rhythmic auditory stimulation by music (RAS-Fast). The beat rate of the music was set to 10% above each patient's preferred gait cadence . The preferred cadence was considered as the mean of the 6 trials during Gait 1.
- Gait without auditory stimulation (Gait2) The investigators choosed a fixed order rather a randomized one, because the use of auditory stimulation may interferes with subsequent tasks. The comfortable gait was proposed as first and last conditions to check this aftereffect.
The fNIRS will used the Brite MKII apparatus. Gait parameters were recorded by FeetMe(R) Monitor (insole version FTM-DK, Atmel firmware version 2.3.10, Nordic firmware version 6.3.15).
Four gait parameters, including speed, cadence, stride length and double support time were analyzed. Gait speed is defined as the walking distance in a second (in cm/s), cadence as the number of steps within a minute walk (in steps/min). Stride length indicates the distance (in cm) from initial contact of one foot to subsequent contact of same foot. Double support time occurs when both feet are in contact with the ground simultaneously, it is normalized to stride time and expressed in % Gait Cycle (%). These 4 parameters are the most commonly used when studying the effect of SAR on gait.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | – | Device: walking 25 m in 4 different conditions30 healthy subject aged between 18 and 40. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy subjects aged between 18 and 40 years
Key inclusion criteria (4 listed)
- Age 18 to 40 years old.
- No known neurological disease
- Benefiting from a social security coverage.
- Sufficient knowledge of the French language to understand the instructions
Key exclusion criteria (6 listed)
- Person under tutorship or curatorship
- Known allergy to components of the fNIRS device: neoprene
- History of neurological disease
- History of rheumatological disease affecting walking
- Pregnant or breastfeeding women
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 |
|---|---|---|
| walking 25 m in 4 different conditionsThe protocol consisted of walking 25 m in 4 different conditions in the following order: Gait1, RAS-Slow, RAS-fast, Gait2. * Gait 1 : preferred cadence without auditory stimulation * RAS-Slow : Gait with low tempo rhythmic auditory stimulation by music (68.5 per minute). * RAS-Fast : Gait with fast tempo (10% above each Gait1 cadence). * Gait2 : preferred cadence without auditory stimulation | Device | Healthy subjects |
Primary outcome
Mean change in the concentration of oxyhemoglobin during the task
Time frame: Day 0
Mean change in the concentration of deoxyhemoglobin during the task
Time frame: Day 0
4 secondary outcomes
Walking speed
Time frame: Day 0
Number of steps within a minute walk (in steps/min)
Time frame: Day 0
stride length
Time frame: Day 0
double support time
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
- Background: PubMed 25725918Altenmuller E, Schlaug G. Apollo's gift: new aspects of neurologic music therapy. Prog Brain Res. 2015;217:237-52. doi: 10.1016/bs.pbr.2014.11.029. Epub 2015 Feb 11.
- Background: PubMed 35898041Bonnal J, Monnet F, Le BT, Pila O, Grosmaire AG, Ozsancak C, Duret C, Auzou P. Relation between Cortical Activation and Effort during Robot-Mediated Walking in Healthy People: A Functional Near-Infrared Spectroscopy Neuroimaging Study (fNIRS). Sensors (Basel). 2022 Jul 25;22(15):5542. doi: 10.3390/s22155542.
- Background: PubMed 30375083Braunlich K, Seger CA, Jentink KG, Buard I, Kluger BM, Thaut MH. Rhythmic auditory cues shape neural network recruitment in Parkinson's disease during repetitive motor behavior. Eur J Neurosci. 2019 Mar;49(6):849-858. doi: 10.1111/ejn.14227. Epub 2018 Dec 3.
- Background: PubMed 32654627Farid L, Jacobs D, Do Santos J, Simon O, Gracies JM, Hutin E. FeetMe(R) Monitor-connected insoles are a valid and reliable alternative for the evaluation of gait speed after stroke. Top Stroke Rehabil. 2021 Mar;28(2):127-134. doi: 10.1080/10749357.2020.1792717. Epub 2020 Jul 13.
- Background: PubMed 30005957Koshimori Y, Thaut MH. Future perspectives on neural mechanisms underlying rhythm and music based neurorehabilitation in Parkinson's disease. Ageing Res Rev. 2018 Nov;47:133-139. doi: 10.1016/j.arr.2018.07.001. Epub 2018 Jul 10.
- Background: PubMed 25646516Merchant H, Grahn J, Trainor L, Rohrmeier M, Fitch WT. Finding the beat: a neural perspective across humans and non-human primates. Philos Trans R Soc Lond B Biol Sci. 2015 Mar 19;370(1664):20140093. doi: 10.1098/rstb.2014.0093.
- Background: PubMed 25725919Thaut MH. The discovery of human auditory-motor entrainment and its role in the development of neurologic music therapy. Prog Brain Res. 2015;217:253-66. doi: 10.1016/bs.pbr.2014.11.030. Epub 2015 Feb 2.
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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.
Auzou PASCAL, Dr principal investigator
CHR d'Orleans
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Centre Hospitalier Régional d'Orléans 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 31 Mar 2023. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mean change in the concentration of oxyhemoglobin during the task (time frame: Day 0). The study lists 2 primary outcomes in all. 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 NCT05789121, which also lists 7 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 31 Mar 2023.