Study of Cortical Activation During Hand and Shoulder Movements in Healthy Subjects (CouNirs)

January 20, 2023 updated by: Centre Hospitalier Régional d'Orléans

Counirs: Study of Cortical Activation During Hand and Shoulder Movements - Contribution of fNIRS in Healthy Subjects

Characterization of cortical activation patterns during movements in healthy adults may help our understanding of how the injured brain works. Upper limb motor tasks are commonly used to assess impaired motor function and to predict recovery in individuals with neurological disorders such as stroke. This study aimed to explore cortical activation patterns associated with movements of the hand and shoulder using functional near-infrared spectroscopy (fNIRS). The investigators hypothesized that the activation pattern observed with fNIRS would differ for shoulder and hand movements. More specifically, the investigators hypothesized that the cerebral activation during hand movements would mainly involve the contralateral hemisphere, particularly the lateral part of primary motor cortex; whereas activation during shoulder movements would be more medial and more extensive than that of the hand.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Stroke is a leading cause of chronic disability worldwide in adults. Upper extremity (hand and arm) impairments are especially prevalent after stroke and cause lasting disabilities. Functional reorganization of the motor cortex may occur in both the ipsilesional and contralesional hemispheres. Thus, knowledge of brain activation patterns during execution of a movement is important both for neuroscience and neurorehabilitation.

The use of brain imaging techniques for post-stroke follow-up is valuable for understanding the mechanisms of cerebral recovery. Functional Near-Infrared Spectroscopy (fNIRS) is a non-invasive technique that assesses neural activation through the measurement of cortical oxygenated and deoxygenated hemoglobin concentrations during motor tasks in a natural.

As remapping of the sensorimotor cortex after stroke with hand impairment can involve the territory of the elbow or shoulder, the investigators aimed to determine if the cortical activation of these regions (hand and shoulder) could be distinguished by fNIRS recordings in healthy subjects. The investigators hypothesized that the activation pattern observed with fNIRS would differ for shoulder and hand movements. More specifically, the investigators hypothesized that the cerebral activation during hand movements would mainly involve the contralateral hemisphere, particularly the lateral part of primary motor cortex; whereas activation during shoulder movements would be more medial and more extensive than that of the hand, involving the contralateral premotor region and supplementary motor cortex. If these three cortical regions could be distinguished by fNIRS, this technique could be used to measure spontaneous motor recovery and rehabilitation-induced recovery after stroke.

The investigations will be carried out by the principal investigator or by specialized technicians from the neurology functional exploration department.

Each acquisition has a duration of 920 seconds, it begins with a rest period of 120 seconds, which corresponds to the baseline.

For each condition the movements are performed at a frequency of 0.5 Hz which seems to be the optimal frequency for observing cortical activation using a metronome. Each movement is therefore performed 10 times per block.

The order of placing the various conditions will be balanced. Between periods of movement, the subject is in a resting position for 30 seconds.

The "movement" and "rest" instructions are given at the start of each phase.

The protocol has 2 conditions:

  • Shoulder task
  • Hand task

After recruiting the participants, the study investigator will check the inclusion and non-inclusion criteria.

On the day of the first acquisition, the subject will present to the neurology department at the time of his appointment.

Then the fNIRS acquisition headset (Brite 24) will be installed by a specialized technician and the procurement instructions will be given.

The acquisition is then carried out. The helmet is only removed at the end of the acquisition

Study Type

Observational

Enrollment (Actual)

24

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
      • Orléans, France, 45067
        • 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

Sampling Method

Non-Probability Sample

Study Population

right handed healthy subjects aged between 18 and 40

Description

Inclusion Criteria:

  • Age:18 to 40
  • Right handed
  • No neurological, rhumatological or cardiac disease
  • Having social security coverage
  • Having expressed his non-objection

Exclusion Criteria:

  • Person under tutorship or curatorship
  • Known allergy to components of the fNIRS device: neoprene
  • Person with known vascular problems

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy participants
right handed healthy participants aged between 18 and 40.
Device: Hand and shoulder task

Hand task: the participant is seated on a chair facing a table, both hands resting on the table. The participant is asked, for each block of 10 seconds, to perform flexion / extension movements of the fingers of the right hand at 0.5 Hz.

Shoulder task: the participant is seated on a chair facing a table, both hands resting on the table. The participant is asked, for each block of 10 seconds, to perform alternating movement of abduction and adduction of the right shoulder at 0.5 Hz with the elbow flexed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change in the concentration of oxyhemoglobin and deoxyhemoglobin during the task
Time Frame: Day 0
Changes in the concentration of oxyhemoglobin and deoxyhemoglobin during the task measured with fNIRS device
Day 0

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Régional d'Orléans

Investigators

  • Principal Investigator: Julien BONNAL, CHR 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)

June 25, 2020

Primary Completion (Actual)

July 16, 2020

Study Completion (Actual)

July 16, 2020

Study Registration Dates

First Submitted

January 11, 2023

First Submitted That Met QC Criteria

January 11, 2023

First Posted (Actual)

January 20, 2023

Study Record Updates

Last Update Posted (Actual)

January 23, 2023

Last Update Submitted That Met QC Criteria

January 20, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CHRO-2020-04

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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