HealthyExoNIRSNCT05298943
Exoskeleton and Brain Activity With fNIRS
A study testing walking in 4 situations in people with Healthy and Gait Disorders, Neurologic, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
Trial summary
Background. Force control is one of the major parameter of motor activity. There is few study concerning the cortical activity imply for different levels of force during gait. Objective. To investigate cortex activation while walking an exoskeleton with 4 levels of guidance force in healthy controls. Methods. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Gait Disorders, Neurologic
- What is being tested?
- walking in 4 situations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteFrance
- Study dates
- 2 Mar 2022to 22 Mar 2022
- Phase
- Interventional
- 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
Who may be able to join
- Healthy volunteers (with no known neurological, rheumatological or cardiological medical history)
- Age between 18 and 40
- Having social security coverage,
- Having given written consent.
- Height > 1.5 meters
- Weight less than 100 kg.
- Respect of the morphological criteria
Who cannot join
- Person under guardianship or curatorship,
- Walking with assistance,
- Trauma or orthopedic disorder that may affect walking,
- Pregnant women,
- Medication that alters alertness and potentially affects walking and attentional abilities,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relation Between Cortical Activation and Graded Force Level During Robot-assistance Walking in Healthy People : A Functional Near-infrared Spectroscopy Neuroimaging Study.
Background. Force control is one of the major parameter of motor activity. There is few study concerning the cortical activity imply for different levels of force during gait.
Objective. To investigate cortex activation while walking an exoskeleton with 4 levels of guidance force in healthy controls.
Methods. The investigators acquired near-infrared spectroscopy (fNIRS) with a 20 channels device (Brite 24® ; Artinis) covering bilaterally most motor control brain regions during exoskeleton walking at different level of force (100 %, 50% aid, 0 % aid and 25 % of resistance) in 24 healthy controls. The investigators measured variations of oxyhemoglobin (HbO2) and deoxyhemoglobin (HbR). The technique was optimized by the use of reference channels (to correct for superficial hemodynamic interference).
Read the detailed description
An important goal of motor systems neuroscience is to characterize how neural activity in the brain mediates movement parameters such as force, velocity, frequency of movement or movement direction. The neural codage of force has been studied in animal and human with TEP , fMRI , functional near-infrared spectroscopy (fNIRS), EEG or magnetic stimulation.
Electrophysiological studies in nonhuman primates demonstrated a correlation between neuronal discharge rates in multiple regions of the contralateral motor cortex and exerted force amplitude .
In humans, functional magnetic resonance imaging (fMRI) studies confirmed the relation between increasing neuronal activation and increasing amplitude of force in the contralateral primary motor/somatosensory (M1/S1) cortices, supplementary motor area (SMA), and premotor cortex. The ipsilateral motor cortex could also contribute to the force codage. There are also evidences that the basal ganglia-thalamo-cortical loop participates to the regulation of force control. The internal portion of the globus pallidus (GPi) and subthalamic nucleus (STN) had a positive increase in percent signal change with increasing force, and the ventral thalamic regions were also implied in the the same way. More recently, studies with fNIRS confirmed the relationship between force level and cerebral activation in contralateral and ipsilateral hemisphere.
Most of the human studies concerned isometric static tasks. Only few studies considered dynamic movements. As a rule, the processing of repetitive transient force changes requires more metabolic activity than the generation and control of a static force. There is a correlation between the force level and cortical changes within the neuronal network in contralateral M1 and anterior cerebellum.
Most of the studies concern the upper limb. To our knowledge only to studied concern the lower limb in an isometric force level. One concerns the neural correlates of quadriceps torque control in chronic obstructive pulmonary disease patients and the other one concerns isometric contractions with the ankle dorsiflexor in healthy controls.
fMRI and TEP are highly sensitive to motion artifacts and not suitable for dynamic proximal joints or gait studies. fNIRS is less sensitive to motion artifacts and has permitted numerous studies of walking under more natural conditions in controls or patients. fMRI and fNIRS are based on the physiological principles of neurovascular coupling, the process by which active brain regions induce a local increase in blood flow to match their energy demands via the dilation of capillaries and arterioles. fMRI measures the blood oxygen level-dependent (BOLD) response corresponding to the ratio of oxy to deoxy-hemoglobin. However, the two moieties of hemoglobin are not individually measured with fMRI. On the contrary, fNIRS measures the two hemoglobin species separately. During this neurovascular coupling, the amount of oxygen supplied is typically greater than that consumed locally, resulting in a substantial increase in HbO2 and a slight reduction in HbR in the region.
Many of the fNIRS studies about gait recorded hemodynamic variations in the prefrontal cortex with dual tasks paradigm. Only few studies concerned the motor cortex.
In recent years, robot-assisted rehabilitation has been used in addition to conventional rehabilitation. It offers opportunities for early, intensive, task-specific management with multi-sensory stimulation that is considered the most efficient for promoting neuroplasticity. Literature suggests that robotic rehabilitation increases the walking ability of patients , walking speed , lower limb muscle strength, step length and walking symmetry . However, the neurophysiological bases of robot-assisted rehabilitation remain poorly known. The use of an exoskeleton makes it possible to control the percentage of aid provided. In this study in healthy subjects the investigators propose to study brain activation in motor regions when walking in an exoskeleton. Four strength levels are studied: total aid (A100%), partial help (A50%), no help (A0%) and resistance of 25 % (R25%) to walking from the exoskeleton. The investigators hypothesize that the level of brain activation measured by fNIRS will increase with the effort provided by the subjects.
- Conditions
- Healthy, Gait Disorders, Neurologic
- Being tested
- walking in 4 situations
- Keywords
- fNIRS, Motor cortex activity, Gait, Effort, exoskeleton
- Medical subject headings
- Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
walking in 4 situationsOther
Recording of cerebral hemodynamic with fNIRS during gait in exoskeleton with Four strength levels of aid : total aid (A100%), partial aid (A50%), no aid (A0%) and resistance of 25 % (R25%) to walking from the exoskeleton. Each subject are recorded during 8 trials for each level (32 trials). The order is counterbalanced among the subjects
| Study group | Role | What they receive |
|---|---|---|
| Subjects with 4 walking situations | Other | Not described Receives: Other: walking in 4 situations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of oxyhemoglobin concentration during gait tasks
Measured: Day 0
Change of desoxyhemoglobin concentration during gait tasks
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 posted28 Mar 2022
- Study start2 Mar 2022
- Primary completion22 Mar 2022
- Study completion22 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascal AUZOU, Dr, Principal investigator, CHR d'Orléans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05298943
- Sponsor's protocol ID
- CHRO-2021-11
- Acronym
- ExoNIRS
- Status last verified
- Mar 2022
- First submitted
- 16 Mar 2022
- Last updated
- 1 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chen WL, Wagner J, Heugel N, Sugar J, Lee YW, Conant L, Malloy M, Heffernan J, Quirk B, Zinos A, Beardsley SA, Prost R, Whelan HT. Functional Near-Infrared Spectroscopy and Its Clinical Application in the Field of Neuroscience: Advances and Future Directions. Front Neurosci. 2020 Jul 9;14:724. doi: 10.3389/fnins.2020.00724. eCollection 2020.
PubMed 32742257Kim H. Corrigendum to "Cerebral hemodynamics predicts the cortical area and coding scheme in the human brain for force generation by wrist muscles" [Behav. Brain Res. 396 (2021) 112865]. Behav Brain Res. 2021 Feb 26;400:113054. doi: 10.1016/j.bbr.2020.113054. Epub 2020 Dec 17. No abstract available.
PubMed 33341645
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relation Between Cortical Activation and Graded Force Level During Robot-assistance Walking in Healthy People : A Functional Near-infrared Spectroscopy Neuroimaging Study.
- ClinicalTrials.gov ID
- NCT05298943
- Acronym / sponsor ID
- ExoNIRS / CHRO-2021-11
- Conditions
- Healthy, Gait Disorders, Neurologic
- Keywords
- fNIRS, Motor cortex activity, Gait, Effort, exoskeleton
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional d'OrléansUniversity, hospital or other
- Study start
- 2 Mar 2022 (actual)
- Primary completion
- 22 Mar 2022 (actual)
- Study completion
- 22 Mar 2022 (actual)
- First posted
- 28 Mar 2022 (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.
Background. Force control is one of the major parameter of motor activity. There is few study concerning the cortical activity imply for different levels of force during gait.
Objective. To investigate cortex activation while walking an exoskeleton with 4 levels of guidance force in healthy controls.
Methods. The investigators acquired near-infrared spectroscopy (fNIRS) with a 20 channels device (Brite 24® ; Artinis) covering bilaterally most motor control brain regions during exoskeleton walking at different level of force (100 %, 50% aid, 0 % aid and 25 % of resistance) in 24 healthy controls. The investigators measured variations of oxyhemoglobin (HbO2) and deoxyhemoglobin (HbR). The technique was optimized by the use of reference channels (to correct for superficial hemodynamic interference).
Detailed description
An important goal of motor systems neuroscience is to characterize how neural activity in the brain mediates movement parameters such as force, velocity, frequency of movement or movement direction. The neural codage of force has been studied in animal and human with TEP , fMRI , functional near-infrared spectroscopy (fNIRS), EEG or magnetic stimulation.
Electrophysiological studies in nonhuman primates demonstrated a correlation between neuronal discharge rates in multiple regions of the contralateral motor cortex and exerted force amplitude .
In humans, functional magnetic resonance imaging (fMRI) studies confirmed the relation between increasing neuronal activation and increasing amplitude of force in the contralateral primary motor/somatosensory (M1/S1) cortices, supplementary motor area (SMA), and premotor cortex. The ipsilateral motor cortex could also contribute to the force codage. There are also evidences that the basal ganglia-thalamo-cortical loop participates to the regulation of force control. The internal portion of the globus pallidus (GPi) and subthalamic nucleus (STN) had a positive increase in percent signal change with increasing force, and the ventral thalamic regions were also implied in the the same way. More recently, studies with fNIRS confirmed the relationship between force level and cerebral activation in contralateral and ipsilateral hemisphere.
Most of the human studies concerned isometric static tasks. Only few studies considered dynamic movements. As a rule, the processing of repetitive transient force changes requires more metabolic activity than the generation and control of a static force. There is a correlation between the force level and cortical changes within the neuronal network in contralateral M1 and anterior cerebellum.
Most of the studies concern the upper limb. To our knowledge only to studied concern the lower limb in an isometric force level. One concerns the neural correlates of quadriceps torque control in chronic obstructive pulmonary disease patients and the other one concerns isometric contractions with the ankle dorsiflexor in healthy controls.
fMRI and TEP are highly sensitive to motion artifacts and not suitable for dynamic proximal joints or gait studies. fNIRS is less sensitive to motion artifacts and has permitted numerous studies of walking under more natural conditions in controls or patients. fMRI and fNIRS are based on the physiological principles of neurovascular coupling, the process by which active brain regions induce a local increase in blood flow to match their energy demands via the dilation of capillaries and arterioles. fMRI measures the blood oxygen level-dependent (BOLD) response corresponding to the ratio of oxy to deoxy-hemoglobin. However, the two moieties of hemoglobin are not individually measured with fMRI. On the contrary, fNIRS measures the two hemoglobin species separately. During this neurovascular coupling, the amount of oxygen supplied is typically greater than that consumed locally, resulting in a substantial increase in HbO2 and a slight reduction in HbR in the region.
Many of the fNIRS studies about gait recorded hemodynamic variations in the prefrontal cortex with dual tasks paradigm. Only few studies concerned the motor cortex.
In recent years, robot-assisted rehabilitation has been used in addition to conventional rehabilitation. It offers opportunities for early, intensive, task-specific management with multi-sensory stimulation that is considered the most efficient for promoting neuroplasticity. Literature suggests that robotic rehabilitation increases the walking ability of patients , walking speed , lower limb muscle strength, step length and walking symmetry . However, the neurophysiological bases of robot-assisted rehabilitation remain poorly known. The use of an exoskeleton makes it possible to control the percentage of aid provided. In this study in healthy subjects the investigators propose to study brain activation in motor regions when walking in an exoskeleton. Four strength levels are studied: total aid (A100%), partial help (A50%), no help (A0%) and resistance of 25 % (R25%) to walking from the exoskeleton. The investigators hypothesize that the level of brain activation measured by fNIRS will increase with the effort provided by the subjects.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with 4 walking situations | Other | Other: walking in 4 situations |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy volunteers (with no known neurological, rheumatological or cardiological medical history)
- Age between 18 and 40
- Having social security coverage,
- Having given written consent.
- Height > 1.5 meters
Key exclusion criteria (5 listed)
- Person under guardianship or curatorship,
- Walking with assistance,
- Trauma or orthopedic disorder that may affect walking,
- Pregnant women,
- Medication that alters alertness and potentially affects walking and attentional abilities,
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 in 4 situationsRecording of cerebral hemodynamic with fNIRS during gait in exoskeleton with Four strength levels of aid : total aid (A100%), partial aid (A50%), no aid (A0%) and resistance of 25 % (R25%) to walking from the exoskeleton. Each subject are recorded during 8 trials for each level (32 trials). The order is counterbalanced among the subjects | Other | Subjects with 4 walking situations |
Primary outcome
Change of oxyhemoglobin concentration during gait tasks
Time frame: Day 0
Change of desoxyhemoglobin concentration during gait tasks
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 1 Apr 2022.
- Background: PubMed 32742257Chen WL, Wagner J, Heugel N, Sugar J, Lee YW, Conant L, Malloy M, Heffernan J, Quirk B, Zinos A, Beardsley SA, Prost R, Whelan HT. Functional Near-Infrared Spectroscopy and Its Clinical Application in the Field of Neuroscience: Advances and Future Directions. Front Neurosci. 2020 Jul 9;14:724. doi: 10.3389/fnins.2020.00724. eCollection 2020.
- Background: PubMed 33341645Kim H. Corrigendum to "Cerebral hemodynamics predicts the cortical area and coding scheme in the human brain for force generation by wrist muscles" [Behav. Brain Res. 396 (2021) 112865]. Behav Brain Res. 2021 Feb 26;400:113054. doi: 10.1016/j.bbr.2020.113054. Epub 2020 Dec 17. No abstract available.
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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.
Pascal AUZOU, Dr principal investigator
CHR d'Orléans
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing walking in 4 situations in people with Healthy and Gait Disorders, Neurologic, 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 7 inclusion and 5 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 1 Apr 2022. 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?
Change of oxyhemoglobin concentration during gait tasks (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 NCT05298943, which also lists 2 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 1 Apr 2022; AzTrials last refreshed its copy on 29 Oct 2026.