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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

France1 site
  • CHR Orléans

    Boissise-le-Roi, 77310

Other trials in France

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.

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 groups in NCT05298943
Study groupRoleWhat they receive
Subjects with 4 walking situationsOtherNot described
Receives: Other: walking in 4 situations

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of oxyhemoglobin concentration during gait tasks

    Measured: Day 0

  2. 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.

  1. First posted28 Mar 2022
  2. Study start2 Mar 2022
  3. Primary completion22 Mar 2022
  4. Study completion22 Mar 2022

Resources

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)
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 32742257
  • Kim 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

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.

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