HealthyCouNirsNCT05691777
Study of Cortical Activation During Hand and Shoulder Movements in Healthy Subjects
An observational study of Healthy, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
Trial summary
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. 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?
- Hand and shoulder task
- Type of treatment
- Medical device
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 25 Jun 2020to 16 Jul 2020
- 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: right handed healthy subjects aged between 18 and 40
Who may be able to join
- Age:18 to 40
- Right handed
- No neurological, rhumatological or cardiac disease
- Having social security coverage
- Having expressed his non-objection
Who cannot join
- Person under tutorship or curatorship
- Known allergy to components of the fNIRS device: neoprene
- Person with known vascular problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Healthy
- Being tested
- Hand and shoulder task
- Keywords
- cortical activation, functional near-infrared spectroscopy, upper limb, motricity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand and shoulder taskDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy participants | right handed healthy participants aged between 18 and 40. Receives: Device: Hand and shoulder task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in the concentration of oxyhemoglobin and deoxyhemoglobin during the task
Changes in the concentration of oxyhemoglobin and deoxyhemoglobin during the task measured with fNIRS device
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 posted20 Jan 2023
- Study start25 Jun 2020
- Primary completion16 Jul 2020
- Study completion16 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julien BONNAL, Principal investigator, CHR d'Orléans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05691777
- Sponsor's protocol ID
- CHRO-2020-04
- Acronym
- CouNirs
- Status last verified
- Jan 2023
- First submitted
- 11 Jan 2023
- Last updated
- 23 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nudo RJ, Milliken GW. Reorganization of movement representations in primary motor cortex following focal ischemic infarcts in adult squirrel monkeys. J Neurophysiol. 1996 May;75(5):2144-9. doi: 10.1152/jn.1996.75.5.2144.
PubMed 8734610Carrera E, Jones PS, Morris RS, Alawneh J, Hong YT, Aigbirhio FI, Fryer TD, Carpenter TA, Warburton EA, Baron JC. Is neural activation within the rescued penumbra impeded by selective neuronal loss? Brain. 2013 Jun;136(Pt 6):1816-29. doi: 10.1093/brain/awt112. Epub 2013 May 16.
PubMed 23682070Csipo T, Mukli P, Lipecz A, Tarantini S, Bahadli D, Abdulhussein O, Owens C, Kiss T, Balasubramanian P, Nyul-Toth A, Hand RA, Yabluchanska V, Sorond FA, Csiszar A, Ungvari Z, Yabluchanskiy A. Assessment of age-related decline of neurovascular coupling responses by functional near-infrared spectroscopy (fNIRS) in humans. Geroscience. 2019 Oct;41(5):495-509. doi: 10.1007/s11357-019-00122-x. Epub 2019 Nov 2.
PubMed 31676966Delorme M, Vergotte G, Perrey S, Froger J, Laffont I. Time course of sensorimotor cortex reorganization during upper extremity task accompanying motor recovery early after stroke: An fNIRS study. Restor Neurol Neurosci. 2019;37(3):207-218. doi: 10.3233/RNN-180877.
PubMed 31227675Kato J, Yamada T, Kawaguchi H, Matsuda K, Higo N. Functional near-infrared-spectroscopy-based measurement of changes in cortical activity in macaques during post-infarct recovery of manual dexterity. Sci Rep. 2020 Apr 15;10(1):6458. doi: 10.1038/s41598-020-63617-0.
PubMed 32296087Lee SH, Jin SH, An J. The difference in cortical activation pattern for complex motor skills: A functional near- infrared spectroscopy study. Sci Rep. 2019 Oct 1;9(1):14066. doi: 10.1038/s41598-019-50644-9.
PubMed 31575954Yang CL, Lim SB, Peters S, Eng JJ. Cortical Activation During Shoulder and Finger Movements in Healthy Adults: A Functional Near-Infrared Spectroscopy (fNIRS) Study. Front Hum Neurosci. 2020 Jul 8;14:260. doi: 10.3389/fnhum.2020.00260. eCollection 2020.
PubMed 32733221Yeo SS, Chang PH, Jang SH. The cortical activation differences between proximal and distal joint movements of the upper extremities: a functional NIRS study. NeuroRehabilitation. 2013;32(4):861-6. doi: 10.3233/NRE-130910.
PubMed 23867412Pinti P, Tachtsidis I, Hamilton A, Hirsch J, Aichelburg C, Gilbert S, Burgess PW. The present and future use of functional near-infrared spectroscopy (fNIRS) for cognitive neuroscience. Ann N Y Acad Sci. 2020 Mar;1464(1):5-29. doi: 10.1111/nyas.13948. Epub 2018 Aug 7.
PubMed 30085354Bonnal J, Ozsancak C, Monnet F, Valery A, Prieur F, Auzou P. Neural Substrates for Hand and Shoulder Movement in Healthy Adults: A Functional near Infrared Spectroscopy Study. Brain Topogr. 2023 Jul;36(4):447-458. doi: 10.1007/s10548-023-00972-x. Epub 2023 May 18.
PubMed 37202647
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Counirs: Study of Cortical Activation During Hand and Shoulder Movements - Contribution of fNIRS in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05691777
- Acronym / sponsor ID
- CouNirs / CHRO-2020-04
- Conditions
- Healthy
- Keywords
- cortical activation, functional near-infrared spectroscopy, upper limb, motricity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional d'OrléansUniversity, hospital or other
- Study start
- 25 Jun 2020 (actual)
- Primary completion
- 16 Jul 2020 (actual)
- Study completion
- 16 Jul 2020 (actual)
- First posted
- 20 Jan 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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy participants | – | Device: Hand and shoulder taskright handed healthy participants aged between 18 and 40. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- right handed healthy subjects aged between 18 and 40
Key inclusion criteria (5 listed)
- Age:18 to 40
- Right handed
- No neurological, rhumatological or cardiac disease
- Having social security coverage
- Having expressed his non-objection
Key exclusion criteria (3 listed)
- Person under tutorship or curatorship
- Known allergy to components of the fNIRS device: neoprene
- Person with known vascular problems
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 |
|---|---|---|
| Hand and shoulder taskHand 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. | Device | Healthy participants |
Primary outcome
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
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 23 Jan 2023.
- Background: PubMed 8734610Nudo RJ, Milliken GW. Reorganization of movement representations in primary motor cortex following focal ischemic infarcts in adult squirrel monkeys. J Neurophysiol. 1996 May;75(5):2144-9. doi: 10.1152/jn.1996.75.5.2144.
- Background: PubMed 23682070Carrera E, Jones PS, Morris RS, Alawneh J, Hong YT, Aigbirhio FI, Fryer TD, Carpenter TA, Warburton EA, Baron JC. Is neural activation within the rescued penumbra impeded by selective neuronal loss? Brain. 2013 Jun;136(Pt 6):1816-29. doi: 10.1093/brain/awt112. Epub 2013 May 16.
- Background: PubMed 31676966Csipo T, Mukli P, Lipecz A, Tarantini S, Bahadli D, Abdulhussein O, Owens C, Kiss T, Balasubramanian P, Nyul-Toth A, Hand RA, Yabluchanska V, Sorond FA, Csiszar A, Ungvari Z, Yabluchanskiy A. Assessment of age-related decline of neurovascular coupling responses by functional near-infrared spectroscopy (fNIRS) in humans. Geroscience. 2019 Oct;41(5):495-509. doi: 10.1007/s11357-019-00122-x. Epub 2019 Nov 2.
- Background: PubMed 31227675Delorme M, Vergotte G, Perrey S, Froger J, Laffont I. Time course of sensorimotor cortex reorganization during upper extremity task accompanying motor recovery early after stroke: An fNIRS study. Restor Neurol Neurosci. 2019;37(3):207-218. doi: 10.3233/RNN-180877.
- Background: PubMed 32296087Kato J, Yamada T, Kawaguchi H, Matsuda K, Higo N. Functional near-infrared-spectroscopy-based measurement of changes in cortical activity in macaques during post-infarct recovery of manual dexterity. Sci Rep. 2020 Apr 15;10(1):6458. doi: 10.1038/s41598-020-63617-0.
- Background: PubMed 31575954Lee SH, Jin SH, An J. The difference in cortical activation pattern for complex motor skills: A functional near- infrared spectroscopy study. Sci Rep. 2019 Oct 1;9(1):14066. doi: 10.1038/s41598-019-50644-9.
- Background: PubMed 32733221Yang CL, Lim SB, Peters S, Eng JJ. Cortical Activation During Shoulder and Finger Movements in Healthy Adults: A Functional Near-Infrared Spectroscopy (fNIRS) Study. Front Hum Neurosci. 2020 Jul 8;14:260. doi: 10.3389/fnhum.2020.00260. eCollection 2020.
- Background: PubMed 23867412Yeo SS, Chang PH, Jang SH. The cortical activation differences between proximal and distal joint movements of the upper extremities: a functional NIRS study. NeuroRehabilitation. 2013;32(4):861-6. doi: 10.3233/NRE-130910.
- Background: PubMed 30085354Pinti P, Tachtsidis I, Hamilton A, Hirsch J, Aichelburg C, Gilbert S, Burgess PW. The present and future use of functional near-infrared spectroscopy (fNIRS) for cognitive neuroscience. Ann N Y Acad Sci. 2020 Mar;1464(1):5-29. doi: 10.1111/nyas.13948. Epub 2018 Aug 7.
- Derived from this study: PubMed 37202647Bonnal J, Ozsancak C, Monnet F, Valery A, Prieur F, Auzou P. Neural Substrates for Hand and Shoulder Movement in Healthy Adults: A Functional near Infrared Spectroscopy Study. Brain Topogr. 2023 Jul;36(4):447-458. doi: 10.1007/s10548-023-00972-x. Epub 2023 May 18.
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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.
Julien BONNAL 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?
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 5 inclusion and 3 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 23 Jan 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 and deoxyhemoglobin during the task (time frame: Day 0). 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 NCT05691777, which also lists 10 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 23 Jan 2023.