Exoskeleton and Brain Activity With fNIRS (ExoNIRS)

March 31, 2022 updated by: Centre Hospitalier Régional d'Orléans

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Boissise-le-Roi, France, 77310
        • CHR Orléans

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Subjects with 4 walking situations
Other: walking in 4 situations
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change of oxyhemoglobin concentration during gait tasks
Time Frame: Day 0
Day 0
Change of desoxyhemoglobin concentration during gait tasks
Time Frame: Day 0
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Régional d'Orléans

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2022

Primary Completion (Actual)

March 22, 2022

Study Completion (Actual)

March 22, 2022

Study Registration Dates

First Submitted

March 16, 2022

First Submitted That Met QC Criteria

March 25, 2022

First Posted (Actual)

March 28, 2022

Study Record Updates

Last Update Posted (Actual)

April 1, 2022

Last Update Submitted That Met QC Criteria

March 31, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHRO-2021-11

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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