HealthyLateralinirsNCT05428917
Evaluation of the Impact of Laterality on Cerebral Activation During a Motor Task of the Upper Limb in Healthy Subjects
A study testing Simple task and complex task in people with Healthy, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
Trial summary
The aim of this study is to investigate the differences in brain activation in healthy subjects during motor tasks, depending on the laterality of the subject, the laterality of the task and the complexity of the task. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Simple task and complex task
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteFrance
- Study dates
- 8 Apr 2022to 6 May 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject from 18 to 60 years old
- Sufficient command of the French language to understand the instructions
- No known neurological medical history
- Benefiting from social security coverage
- For right-handed subjects: Edinburgh laterality test QL> 40
- For left-handed subjects: Edinburgh laterality test QL< -40
Who cannot join
- Known allergy to components of the fNIRS device : neoprene
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Impact of Laterality on Cerebral Activation During a Motor Task of the Upper Limb Using fNIRS Technology in Healthy Subjects
The aim of this study is to investigate the differences in brain activation in healthy subjects during motor tasks, depending on the laterality of the subject, the laterality of the task and the complexity of the task. It seems that the laterality of activation is less marked in left-handed people, when using the non-dominant hand and when performing a complex task. The objective of this study is to highlight profiles of subject and modality of use of the hand with a specific lateralization of cerebral activation.
Read the detailed description
Stroke frequently leads to upper limb deficit. The recovery of motor skills depends on many factors including laterality. The literature shows that cerebral activation during motor tasks differs depending on whether one is right-handed or left-handed and whether one uses the dominant hand or not. These differences probably lead to different recovery mechanisms depending on the side of the lesion and the laterality. An imaging technique is particularly suitable for exploring these different mechanisms: fNIRS (Functional Near Infra Red Spectroscopy). This method allows (like fMRI) to study cerebral neurovascular coupling. It is based on the fact that an activated brain region increases its local blood flow. Oxygenated (HbO) and deoxygenated (HbR) hemoglobin absorb infrared light and it is then possible to identify the cerebral cortical regions involved in a given task. This technique therefore makes it possible to study cerebral activation under more ecological conditions than fMRI and is thus particularly suitable for exploring rehabilitation techniques.
This research aims to study and compare in healthy subjects, using an fNIRS apparatus, the brain regions involved in the performance of different motor tasks according to the laterality of the task and the subject.
The investigations will be carried out by the principal investigator or by specialized technicians from the neurology functional exploration department.
Stroke frequently leads to upper limb deficit. The recovery of motor skills depends on many factors including laterality. The literature shows that cerebral activation during motor tasks differs depending on whether one is right-handed or left-handed and whether one uses the dominant hand or not. These differences probably lead to different recovery mechanisms depending on the side of the lesion and the laterality. An imaging technique is particularly suitable for exploring these different mechanisms: fNIRS (Functional Near Infra Red Spectroscopy). This method allows (like fMRI) to study cerebral neurovascular coupling. It is based on the fact that an activated brain region increases its local blood flow. Oxygenated (HbO) and deoxygenated (HbR) hemoglobin absorb infrared light and it is then possible to identify the cerebral cortical regions involved in a given task. This technique therefore makes it possible to study cerebral activation under more ecological conditions than fMRI and is thus particularly suitable for exploring rehabilitation techniques.
This research aims to study and compare in healthy subjects, using an fNIRS apparatus, the brain regions involved in the performance of different motor tasks according to the laterality of the task and the subject.
The investigations will be carried out by the principal investigator or by specialized technicians from the neurology functional exploration department.
The acquisition has a duration of 25 minutes, it begins with a rest period of 120 seconds, which corresponds to the baseline. Four different tasks are performed during the acquisition for each subject:
- Simple task right hand (SD)
- Simple task left hand (SG)
- Complex task right hand (CD)
- Complex stain left hand (CG)
The design is a block design, each task, which has a duration of 20 seconds, is carried out 8 times per acquisition. There is therefore a total of 32 tasks whose order will be randomized.
For simple tasks, movements are performed at a frequency of 0.5 Hz which appears to be the optimal frequency for observing cortical activation using a metronome.
Between periods of movement, the subject is in a rest position for a period from 15 to 25 seconds.
Instructions are given verbally at the start of each phase. After recruiting the subjects, the study investigator will check the inclusion and exclusion criteria.
If the subject can integrate the protocol, the acquisition will then be planned.
On the day of the acquisition, the fNIRS acquisition helmet (Brite MKII) will be installed by a specialist technician and instructions will be given. The recording is then made.
- Conditions
- Healthy
- Being tested
- Simple task, complex task
- Keywords
- Laterality, motor task, cerebral activation, near infrared spectroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simple taskBehavioural
The subject is seated on a chair facing a table, both hands resting on the table.
The subject is asked, for each block of 20 seconds, to perform flexion / extension movements of the fingers of the left hand at 0.5 Hz.
complex taskBehavioural
The subject is seated on a chair facing a table, both hands resting on the table.
The subject is asked, for each block of 20 seconds, to perform an exercise based on the nine hole peg test
| Study group | Role | What they receive |
|---|---|---|
| Near infrared spectroscopy | Experimental | This method allows (like fMRI) to study cerebral neurovascular coupling. It is based on the fact that an activated brain region increases its local blood flow. Oxygenated (HbO) and deoxygenated (HbR) hemoglobin absorb infrared light and it is then possible to identify the cerebral cortical regions involved in a given task. This technique therefore makes it possible to study cerebral activation under more ecological conditions than fMRI and is thus particularly suitable for exploring rehabilitation techniques. Receives: Behavioral: Simple task; Behavioral: complex task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Laterality index using t values
Compare the asymmetry of activation of the sensorimotor cortex during a complex motor task on the dominant side between right-handers and left-handers.
Measured: Minutes 25
Secondary outcomes (2)
concentration of oxyhemoglobin measured with fnirs device
Assess the effect of task complexity and the effect of using the dominant or non-dominant side
Measured: Minutes 25
concentration of deoxyhemoglobin measured with fnirs device
Assess the effect of task complexity and the effect of using the dominant or non-dominant side
Measured: minutes 25
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2022
- Study start8 Apr 2022
- Primary completion6 May 2022
- Study completion6 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 60 healthy subjects (30 left handed and 30 right handed) will be recruited and will carry out the acquisition.
- Masking
- None (open label)
- Enrolment
- 59 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, Regional Hospital Center of ORLEANS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05428917
- Sponsor's protocol ID
- CHRO-2021-13
- Acronym
- Lateralinirs
- Status last verified
- Dec 2022
- First submitted
- 17 Jun 2022
- Last updated
- 28 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bartur G, Pratt H, Dickstein R, Frenkel-Toledo S, Geva A, Soroker N. Electrophysiological manifestations of mirror visual feedback during manual movement. Brain Res. 2015 May 5;1606:113-24. doi: 10.1016/j.brainres.2015.02.029. Epub 2015 Feb 23.
PubMed 25721791Bondi D, Prete G, Malatesta G, Robazza C. Laterality in Children: Evidence for Task-Dependent Lateralization of Motor Functions. Int J Environ Res Public Health. 2020 Sep 15;17(18):6705. doi: 10.3390/ijerph17186705.
PubMed 32942557Harris JE, Eng JJ. Individuals with the dominant hand affected following stroke demonstrate less impairment than those with the nondominant hand affected. Neurorehabil Neural Repair. 2006 Sep;20(3):380-9. doi: 10.1177/1545968305284528.
PubMed 16885424Ludemann-Podubecka J, Bosl K, Theilig S, Wiederer R, Nowak DA. The Effectiveness of 1 Hz rTMS Over the Primary Motor Area of the Unaffected Hemisphere to Improve Hand Function After Stroke Depends on Hemispheric Dominance. Brain Stimul. 2015 Jul-Aug;8(4):823-30. doi: 10.1016/j.brs.2015.02.004. Epub 2015 Mar 16.
PubMed 25828427Duboc V, Dufourcq P, Blader P, Roussigne M. Asymmetry of the Brain: Development and Implications. Annu Rev Genet. 2015;49:647-72. doi: 10.1146/annurev-genet-112414-055322. Epub 2015 Oct 6.
PubMed 26442849Grabowska A, Gut M, Binder M, Forsberg L, Rymarczyk K, Urbanik A. Switching handedness: fMRI study of hand motor control in right-handers, left-handers and converted left-handers. Acta Neurobiol Exp (Wars). 2012;72(4):439-51. doi: 10.55782/ane-2012-1914.
PubMed 23377273Jin SH, Lee SH, Yang ST, An J. Hemispheric asymmetry in hand preference of right-handers for passive vibrotactile perception: an fNIRS study. Sci Rep. 2020 Aug 7;10(1):13423. doi: 10.1038/s41598-020-70496-y.
PubMed 32770115Kim SG, Ashe J, Hendrich K, Ellermann JM, Merkle H, Ugurbil K, Georgopoulos AP. Functional magnetic resonance imaging of motor cortex: hemispheric asymmetry and handedness. Science. 1993 Jul 30;261(5121):615-7. doi: 10.1126/science.8342027.
PubMed 8342027Lee 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 31575954Oldfield RC. The assessment and analysis of handedness: the Edinburgh inventory. Neuropsychologia. 1971 Mar;9(1):97-113. doi: 10.1016/0028-3932(71)90067-4. No abstract available.
PubMed 5146491O'Regan L, Serrien DJ. Individual Differences and Hemispheric Asymmetries for Language and Spatial Attention. Front Hum Neurosci. 2018 Oct 4;12:380. doi: 10.3389/fnhum.2018.00380. eCollection 2018.
PubMed 30337864Solodkin A, Hlustik P, Noll DC, Small SL. Lateralization of motor circuits and handedness during finger movements. Eur J Neurol. 2001 Sep;8(5):425-34. doi: 10.1046/j.1468-1331.2001.00242.x.
PubMed 11554905Vingerhoets G, Acke F, Alderweireldt AS, Nys J, Vandemaele P, Achten E. Cerebral lateralization of praxis in right- and left-handedness: same pattern, different strength. Hum Brain Mapp. 2012 Apr;33(4):763-77. doi: 10.1002/hbm.21247. Epub 2011 Apr 15.
PubMed 21500314
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of Laterality on Cerebral Activation During a Motor Task of the Upper Limb Using fNIRS Technology in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05428917
- Acronym / sponsor ID
- Lateralinirs / CHRO-2021-13
- Conditions
- Healthy
- Keywords
- Laterality, motor task, cerebral activation, near infrared spectroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional d'OrléansUniversity, hospital or other
- Study start
- 8 Apr 2022 (actual)
- Primary completion
- 6 May 2022 (actual)
- Study completion
- 6 May 2022 (actual)
- First posted
- 23 Jun 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.
The aim of this study is to investigate the differences in brain activation in healthy subjects during motor tasks, depending on the laterality of the subject, the laterality of the task and the complexity of the task. It seems that the laterality of activation is less marked in left-handed people, when using the non-dominant hand and when performing a complex task. The objective of this study is to highlight profiles of subject and modality of use of the hand with a specific lateralization of cerebral activation.
Detailed description
Stroke frequently leads to upper limb deficit. The recovery of motor skills depends on many factors including laterality. The literature shows that cerebral activation during motor tasks differs depending on whether one is right-handed or left-handed and whether one uses the dominant hand or not. These differences probably lead to different recovery mechanisms depending on the side of the lesion and the laterality. An imaging technique is particularly suitable for exploring these different mechanisms: fNIRS (Functional Near Infra Red Spectroscopy). This method allows (like fMRI) to study cerebral neurovascular coupling. It is based on the fact that an activated brain region increases its local blood flow. Oxygenated (HbO) and deoxygenated (HbR) hemoglobin absorb infrared light and it is then possible to identify the cerebral cortical regions involved in a given task. This technique therefore makes it possible to study cerebral activation under more ecological conditions than fMRI and is thus particularly suitable for exploring rehabilitation techniques.
This research aims to study and compare in healthy subjects, using an fNIRS apparatus, the brain regions involved in the performance of different motor tasks according to the laterality of the task and the subject.
The investigations will be carried out by the principal investigator or by specialized technicians from the neurology functional exploration department.
Stroke frequently leads to upper limb deficit. The recovery of motor skills depends on many factors including laterality. The literature shows that cerebral activation during motor tasks differs depending on whether one is right-handed or left-handed and whether one uses the dominant hand or not. These differences probably lead to different recovery mechanisms depending on the side of the lesion and the laterality. An imaging technique is particularly suitable for exploring these different mechanisms: fNIRS (Functional Near Infra Red Spectroscopy). This method allows (like fMRI) to study cerebral neurovascular coupling. It is based on the fact that an activated brain region increases its local blood flow. Oxygenated (HbO) and deoxygenated (HbR) hemoglobin absorb infrared light and it is then possible to identify the cerebral cortical regions involved in a given task. This technique therefore makes it possible to study cerebral activation under more ecological conditions than fMRI and is thus particularly suitable for exploring rehabilitation techniques.
This research aims to study and compare in healthy subjects, using an fNIRS apparatus, the brain regions involved in the performance of different motor tasks according to the laterality of the task and the subject.
The investigations will be carried out by the principal investigator or by specialized technicians from the neurology functional exploration department.
The acquisition has a duration of 25 minutes, it begins with a rest period of 120 seconds, which corresponds to the baseline. Four different tasks are performed during the acquisition for each subject:
- Simple task right hand (SD)
- Simple task left hand (SG)
- Complex task right hand (CD)
- Complex stain left hand (CG)
The design is a block design, each task, which has a duration of 20 seconds, is carried out 8 times per acquisition. There is therefore a total of 32 tasks whose order will be randomized.
For simple tasks, movements are performed at a frequency of 0.5 Hz which appears to be the optimal frequency for observing cortical activation using a metronome.
Between periods of movement, the subject is in a rest position for a period from 15 to 25 seconds.
Instructions are given verbally at the start of each phase. After recruiting the subjects, the study investigator will check the inclusion and exclusion criteria.
If the subject can integrate the protocol, the acquisition will then be planned.
On the day of the acquisition, the fNIRS acquisition helmet (Brite MKII) will be installed by a specialist technician and instructions will be given. The recording is then made.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 60 healthy subjects (30 left handed and 30 right handed) will be recruited and will carry out the acquisition.
| Arm | Type | Receives |
|---|---|---|
| Near infrared spectroscopy | Experimental | Behavioral: Simple task, Behavioral: complex taskThis method allows (like fMRI) to study cerebral neurovascular coupling. It is based on the fact that an activated brain region increases its local blood flow. Oxygenated (HbO) and deoxygenated (HbR) hemoglobin absorb infrared light and it is then possible to identify the cerebral cortical regions involved in a given task. This technique therefore makes it possible to study cerebral activation under more ecological conditions than fMRI and is thus particularly suitable for exploring rehabilitation techniques. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Subject from 18 to 60 years old
- Sufficient command of the French language to understand the instructions
- No known neurological medical history
- Benefiting from social security coverage
- For right-handed subjects: Edinburgh laterality test QL> 40
Key exclusion criteria (1 listed)
- Known allergy to components of the fNIRS device : neoprene
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 |
|---|---|---|
| Simple taskThe subject is seated on a chair facing a table, both hands resting on the table. The subject is asked, for each block of 20 seconds, to perform flexion / extension movements of the fingers of the left hand at 0.5 Hz. | Behavioural | Near infrared spectroscopy |
| complex taskThe subject is seated on a chair facing a table, both hands resting on the table. The subject is asked, for each block of 20 seconds, to perform an exercise based on the nine hole peg test | Behavioural | Near infrared spectroscopy |
Primary outcome
Laterality index using t values
Time frame: Minutes 25
Compare the asymmetry of activation of the sensorimotor cortex during a complex motor task on the dominant side between right-handers and left-handers.
2 secondary outcomes
concentration of oxyhemoglobin measured with fnirs device
Time frame: Minutes 25
concentration of deoxyhemoglobin measured with fnirs device
Time frame: minutes 25
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 28 Dec 2022.
- Background: PubMed 25721791Bartur G, Pratt H, Dickstein R, Frenkel-Toledo S, Geva A, Soroker N. Electrophysiological manifestations of mirror visual feedback during manual movement. Brain Res. 2015 May 5;1606:113-24. doi: 10.1016/j.brainres.2015.02.029. Epub 2015 Feb 23.
- Background: PubMed 32942557Bondi D, Prete G, Malatesta G, Robazza C. Laterality in Children: Evidence for Task-Dependent Lateralization of Motor Functions. Int J Environ Res Public Health. 2020 Sep 15;17(18):6705. doi: 10.3390/ijerph17186705.
- Background: PubMed 16885424Harris JE, Eng JJ. Individuals with the dominant hand affected following stroke demonstrate less impairment than those with the nondominant hand affected. Neurorehabil Neural Repair. 2006 Sep;20(3):380-9. doi: 10.1177/1545968305284528.
- Background: PubMed 25828427Ludemann-Podubecka J, Bosl K, Theilig S, Wiederer R, Nowak DA. The Effectiveness of 1 Hz rTMS Over the Primary Motor Area of the Unaffected Hemisphere to Improve Hand Function After Stroke Depends on Hemispheric Dominance. Brain Stimul. 2015 Jul-Aug;8(4):823-30. doi: 10.1016/j.brs.2015.02.004. Epub 2015 Mar 16.
- Background: PubMed 26442849Duboc V, Dufourcq P, Blader P, Roussigne M. Asymmetry of the Brain: Development and Implications. Annu Rev Genet. 2015;49:647-72. doi: 10.1146/annurev-genet-112414-055322. Epub 2015 Oct 6.
- Background: PubMed 23377273Grabowska A, Gut M, Binder M, Forsberg L, Rymarczyk K, Urbanik A. Switching handedness: fMRI study of hand motor control in right-handers, left-handers and converted left-handers. Acta Neurobiol Exp (Wars). 2012;72(4):439-51. doi: 10.55782/ane-2012-1914.
- Background: PubMed 32770115Jin SH, Lee SH, Yang ST, An J. Hemispheric asymmetry in hand preference of right-handers for passive vibrotactile perception: an fNIRS study. Sci Rep. 2020 Aug 7;10(1):13423. doi: 10.1038/s41598-020-70496-y.
- Background: PubMed 8342027Kim SG, Ashe J, Hendrich K, Ellermann JM, Merkle H, Ugurbil K, Georgopoulos AP. Functional magnetic resonance imaging of motor cortex: hemispheric asymmetry and handedness. Science. 1993 Jul 30;261(5121):615-7. doi: 10.1126/science.8342027.
- 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 5146491Oldfield RC. The assessment and analysis of handedness: the Edinburgh inventory. Neuropsychologia. 1971 Mar;9(1):97-113. doi: 10.1016/0028-3932(71)90067-4. No abstract available.
- Background: PubMed 30337864O'Regan L, Serrien DJ. Individual Differences and Hemispheric Asymmetries for Language and Spatial Attention. Front Hum Neurosci. 2018 Oct 4;12:380. doi: 10.3389/fnhum.2018.00380. eCollection 2018.
- Background: PubMed 11554905Solodkin A, Hlustik P, Noll DC, Small SL. Lateralization of motor circuits and handedness during finger movements. Eur J Neurol. 2001 Sep;8(5):425-34. doi: 10.1046/j.1468-1331.2001.00242.x.
- Individual participant dataSharing planned: No
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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
Regional Hospital Center of ORLEANS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simple task and complex task in people with 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 6 inclusion and 1 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 28 Dec 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?
Laterality index using t values (time frame: Minutes 25). 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 NCT05428917, which also lists 13 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 28 Dec 2022.