Amyotrophic Lateral SclerosisNCT04918251
EEG and TMS-based Biomarkers of ALS, MS and FTD
An observational study of Amyotrophic Lateral Sclerosis and Frontotemporal Dementia, run by University of Dublin, Trinity College at 1 site in Ireland.
Trial summary
The purpose of this observational study is to improve understanding of the biology of why ALS, MS and FTD have different effects on different people and facilitate better measurement of the disease in future drug testing. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Amyotrophic Lateral Sclerosis, Frontotemporal Dementia, Multiple Sclerosis
- What is being tested?
- 128 electrode electroencephalography (EEG) and Transcranial magnetic stimulation (TMS)
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 1 siteIreland
- Study dates
- Sep 2012to Apr 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy controls and patients diagnosed with ALS, FTD or MS
Who may be able to join
- Age >18 years and able to give informed written or verbal (in the presence of two witnesses) consent.
- In the case of non-control subjects, a clinical diagnosis of:
- Probable frontotemporal dementia (FTD) including behavioural variant FTD, semantic dementia or primary progressive aphasia) with supportive brain imaging or known FTD causing genetic mutation (ii) Multiple sclerosis (MS) according to the McDonald criteria (Polman et al., 2011) or (iii) Possible, probable or definite amyotrophic lateral sclerosis (ALS) according to the El Escorial Criteria Revised (Brooks et al. 2000)
Who cannot join
- Any diagnosed neurological/muscular disease other than ALS, MS or FTD
- Use of neuro- or myo-modulatory medications except riluzole
- Inability to participate due to disease-related motor symptoms (e.g. inability to sit for the required time or click the mouse to respond)
- Upper body metallic implants
- History of seizure disorders in the participant or immediate family members
- Anxiety-induced fainting
Show all 9Show fewer
- Regular migraine
- Evidence of significant respiratory insufficiency
- Sleep time >2 hours below normal and/or alcohol consumption the night before data collection (in which case, recording session will be rescheduled).
Trial locations and contacts
1 site in 1 country.
Ireland1 site, 1 recruiting
- Recruiting
Academic Unit of Neurology, Trinity College Dublin, The University of Dublin
Dublin, Leinster, Dublin 2
Orla Hardiman, BSc MB BCh BAO MD FRCPI FAAN, 018964497, hardimao@tcd.ie
Roisin McMackin, BA PhD, 0894888697, mcmackr@tcd.ie
About this study
Official title: Investigation of EEG and TMS-based Biomarkers of Amyotrophic Lateral Sclerosis, Multiple Sclerosis and Frontotemporal Dementia
The purpose of this observational study is to improve understanding of the biology of why ALS, MS and FTD have different effects on different people and facilitate better measurement of the disease in future drug testing. To do this, brain and spinal cord neural network functionality will be measured over time, in addition to profiling of movement and non-movement symptoms, in large groups of patients, as well as in a population-based sample of the healthy population. Patterns of dysfunction which relate to patients' diagnosis and coinciding and future symptoms which align with categories of patients with similar prognoses will be investigated and their ability to predict incident patients' symptoms in future will be measured.
Read the detailed description
The aim of this project is to characterize spatiotemporal patterns of central nervous system dysfunction that correlate with clinical features of ALS, MS and FTD, to provide non-invasive electrophysiological measurements that can be used in a clinical setting to inform stratification of patients in clinical trials, and to provide data driven diagnostic and prognostic biomarkers and objective clinical trial outcome measures. Such dysfunction will be investigated by recording single- and paired-pulse transcranial magnetic stimulation (TMS)-associated electromyography (EMG) during rest and by recording electroencephalography (EEG) during rest and during cognitive-motor tasks.
- Being tested
- 128 electrode electroencephalography (EEG), Transcranial magnetic stimulation (TMS)
- Keywords
- EEG, TMS, Neurodegeneration, Network, Electrophysiology, Biomarkers, Cognitive, Behavioural, Motor
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Frontotemporal Dementia, Multiple Sclerosis, Nerve Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
128 electrode electroencephalography (EEG)Procedure or surgery
128 electrode EEG will be non-invasively recorded from electrodes placed in a montage over the scalp while the participant is resting or performing tasks designed to engage specific cortical motor networks of interest (cognitive, behavioural, motor and sensory)
Transcranial magnetic stimulation (TMS)Procedure or surgery
Single and paired pulse TMS protocol will be delivered while surface bipolar EMG is recorded over hand muscles to interrogate corticospinal tract function and cortical motor network component functions
| Study group | Role | What they receive |
|---|---|---|
| Controls | Individuals from the Irish population with no psychiatric, psychological, neurological or muscular disease diagnosis Receives: Procedure: 128 electrode electroencephalography (EEG); Procedure: Transcranial magnetic stimulation (TMS) | |
| Amyotrophic lateral sclerosis patients | Not described Receives: Procedure: 128 electrode electroencephalography (EEG); Procedure: Transcranial magnetic stimulation (TMS) | |
| Multiple sclerosis patients | Not described Receives: Procedure: 128 electrode electroencephalography (EEG); Procedure: Transcranial magnetic stimulation (TMS) | |
| Frontotemporal dementia patients | Not described Receives: Procedure: 128 electrode electroencephalography (EEG); Procedure: Transcranial magnetic stimulation (TMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis-related difference in EEG or TMS measurements
Differences in single or paired pulse TMS measures or time and/or frequency domain EEG characteristics between those within each patient cohort and controls
Measured: Baseline recording
Prognosis-related EEG or TMS measurements
Patient cohort single or paired pulse TMS measures or time and/or frequency domain EEG characteristics which show significant correlation to cognitive, behavioural, motor and/or sensory task performance, to disease duration or to survival time
Measured: Baseline recording
Diagnosis-related changes in EEG or TMS measurements
Differences in rate of change (slope) across time of single or paired pulse TMS measures or time and/or frequency domain EEG characteristics between those within each patient cohort relative to controls
Measured: Baseline to final visit assessed up to 2 years after baseline
Prognosis-related changes in EEG or TMS measurements
Rates of change (slope) across time of patient cohort single or paired pulse TMS measures or time and/or frequency domain EEG characteristics which show significant correlation to cognitive, behavioural, motor and/or sensory task performance, to disease duration or to survival time
Measured: Baseline to final visit assessed up to 2 years after baseline
Secondary outcomes (2)
Diagnosis-specific changes in EEG or TMS measurements
Differences in rate of change (slope) across time of single or paired pulse TMS measures or time and/or frequency domain EEG characteristics between patient cohorts
Measured: Baseline to final visit assessed up to 2 years after baseline
Diagnosis-specific difference in EEG or TMS measurements
Differences in single or paired pulse TMS measures or time and/or frequency domain EEG characteristics between patient cohorts
Measured: Baseline recording
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2021
- Study startSep 2012
- Primary completionFeb 2023 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Amyotrophic Lateral SclerosisStudies 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Dublin, Trinity College
- Sponsor type
- University, hospital or other
- Collaborators
- Motor Neurone Disease Association, UK, Irish Research Council, Health Research Board, IE, Research Motor Neurone, IE, Thierry Latran Foundation, FR, ALS Association, USA
- Responsible party
- Principal investigator, Orla Hardiman, University of Dublin, Trinity College
- Investigators
- Orla Hardiman, BSc MB BCh BAO MD FRCPI FAAN, Principal investigator, Academic Unit of Neurology, Trinity College Dublin, The University of Dublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04918251
- Sponsor's protocol ID
- CRFSJ00170
- Other IDs
- CRFSJ00171
- Status last verified
- Jun 2021
- First submitted
- 1 Apr 2021
- Last updated
- 8 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Raw data from this study may be made available in anonymized form upon request from qualified investigators subject to the approval by the Data Protection Office (DPO) and Office of Corporate Partnership and Knowledge Exchanges (OCPKE) in Trinity College Dublin, the University of Dublin.
Publications
McMackin R, Dukic S, Broderick M, Iyer PM, Pinto-Grau M, Mohr K, Chipika R, Coffey A, Buxo T, Schuster C, Gavin B, Heverin M, Bede P, Pender N, Lalor EC, Muthuraman M, Hardiman O, Nasseroleslami B. Dysfunction of attention switching networks in amyotrophic lateral sclerosis. Neuroimage Clin. 2019;22:101707. doi: 10.1016/j.nicl.2019.101707. Epub 2019 Feb 2.
PubMed 30735860Dukic S, McMackin R, Buxo T, Fasano A, Chipika R, Pinto-Grau M, Costello E, Schuster C, Hammond M, Heverin M, Coffey A, Broderick M, Iyer PM, Mohr K, Gavin B, Pender N, Bede P, Muthuraman M, Lalor EC, Hardiman O, Nasseroleslami B. Patterned functional network disruption in amyotrophic lateral sclerosis. Hum Brain Mapp. 2019 Nov 1;40(16):4827-4842. doi: 10.1002/hbm.24740. Epub 2019 Jul 26.
PubMed 31348605McMackin R, Dukic S, Costello E, Pinto-Grau M, Fasano A, Buxo T, Heverin M, Reilly R, Muthuraman M, Pender N, Hardiman O, Nasseroleslami B. Localization of Brain Networks Engaged by the Sustained Attention to Response Task Provides Quantitative Markers of Executive Impairment in Amyotrophic Lateral Sclerosis. Cereb Cortex. 2020 Jul 30;30(9):4834-4846. doi: 10.1093/cercor/bhaa076.
PubMed 32318719McMackin R, Dukic S, Costello E, Pinto-Grau M, Keenan O, Fasano A, Buxo T, Heverin M, Reilly R, Pender N, Hardiman O, Nasseroleslami B. Sustained attention to response task-related beta oscillations relate to performance and provide a functional biomarker in ALS. J Neural Eng. 2021 Feb 25;18(2). doi: 10.1088/1741-2552/abd829.
PubMed 33395671Iyer PM, Mohr K, Broderick M, Gavin B, Burke T, Bede P, Pinto-Grau M, Pender NP, McLaughlin R, Vajda A, Heverin M, Lalor EC, Hardiman O, Nasseroleslami B. Mismatch Negativity as an Indicator of Cognitive Sub-Domain Dysfunction in Amyotrophic Lateral Sclerosis. Front Neurol. 2017 Aug 15;8:395. doi: 10.3389/fneur.2017.00395. eCollection 2017.
PubMed 28861032Nasseroleslami B, Dukic S, Broderick M, Mohr K, Schuster C, Gavin B, McLaughlin R, Heverin M, Vajda A, Iyer PM, Pender N, Bede P, Lalor EC, Hardiman O. Characteristic Increases in EEG Connectivity Correlate With Changes of Structural MRI in Amyotrophic Lateral Sclerosis. Cereb Cortex. 2019 Jan 1;29(1):27-41. doi: 10.1093/cercor/bhx301.
PubMed 29136131Iyer PM, Egan C, Pinto-Grau M, Burke T, Elamin M, Nasseroleslami B, Pender N, Lalor EC, Hardiman O. Functional Connectivity Changes in Resting-State EEG as Potential Biomarker for Amyotrophic Lateral Sclerosis. PLoS One. 2015 Jun 19;10(6):e0128682. doi: 10.1371/journal.pone.0128682. eCollection 2015.
PubMed 26091258
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of EEG and TMS-based Biomarkers of Amyotrophic Lateral Sclerosis, Multiple Sclerosis and Frontotemporal Dementia
- ClinicalTrials.gov ID
- NCT04918251
- Acronym / sponsor ID
- CRFSJ00170
- Keywords
- EEG, TMS, Neurodegeneration, Network, Electrophysiology, Biomarkers, Cognitive, Behavioural
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of Dublin, Trinity CollegeUniversity, hospital or other
- Collaborators
- Motor Neurone Disease Association, UK, Irish Research Council, Health Research Board, IE, Research Motor Neurone, IE, Thierry Latran Foundation, FR, ALS Association, USA
- Study start
- Sep 2012 (actual)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 8 Jun 2021 (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 purpose of this observational study is to improve understanding of the biology of why ALS, MS and FTD have different effects on different people and facilitate better measurement of the disease in future drug testing. To do this, brain and spinal cord neural network functionality will be measured over time, in addition to profiling of movement and non-movement symptoms, in large groups of patients, as well as in a population-based sample of the healthy population. Patterns of dysfunction which relate to patients' diagnosis and coinciding and future symptoms which align with categories of patients with similar prognoses will be investigated and their ability to predict incident patients' symptoms in future will be measured.
Detailed description
The aim of this project is to characterize spatiotemporal patterns of central nervous system dysfunction that correlate with clinical features of ALS, MS and FTD, to provide non-invasive electrophysiological measurements that can be used in a clinical setting to inform stratification of patients in clinical trials, and to provide data driven diagnostic and prognostic biomarkers and objective clinical trial outcome measures. Such dysfunction will be investigated by recording single- and paired-pulse transcranial magnetic stimulation (TMS)-associated electromyography (EMG) during rest and by recording electroencephalography (EEG) during rest and during cognitive-motor tasks.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Controls | – | Procedure: 128 electrode electroencephalography (EEG), Procedure: Transcranial magnetic stimulation (TMS)Individuals from the Irish population with no psychiatric, psychological, neurological or muscular disease diagnosis |
| Amyotrophic lateral sclerosis patients | – | Procedure: 128 electrode electroencephalography (EEG), Procedure: Transcranial magnetic stimulation (TMS) |
| Multiple sclerosis patients | – | Procedure: 128 electrode electroencephalography (EEG), Procedure: Transcranial magnetic stimulation (TMS) |
| Frontotemporal dementia patients | – | Procedure: 128 electrode electroencephalography (EEG), Procedure: Transcranial magnetic stimulation (TMS) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy controls and patients diagnosed with ALS, FTD or MS
Key inclusion criteria (3 listed)
- Age >18 years and able to give informed written or verbal (in the presence of two witnesses) consent.
- In the case of non-control subjects, a clinical diagnosis of:
Key exclusion criteria (9 listed)
- Any diagnosed neurological/muscular disease other than ALS, MS or FTD
- Use of neuro- or myo-modulatory medications except riluzole
- Inability to participate due to disease-related motor symptoms (e.g. inability to sit for the required time or click the mouse to respond)
- Upper body metallic implants
- History of seizure disorders in the participant or immediate family members
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 |
|---|---|---|
| 128 electrode electroencephalography (EEG)128 electrode EEG will be non-invasively recorded from electrodes placed in a montage over the scalp while the participant is resting or performing tasks designed to engage specific cortical motor networks of interest (cognitive, behavioural, motor and sensory) | Procedure or surgery | Amyotrophic lateral sclerosis patients, Controls, Frontotemporal dementia patients, Multiple sclerosis patients |
| Transcranial magnetic stimulation (TMS)Single and paired pulse TMS protocol will be delivered while surface bipolar EMG is recorded over hand muscles to interrogate corticospinal tract function and cortical motor network component functions | Procedure or surgery | Amyotrophic lateral sclerosis patients, Controls, Frontotemporal dementia patients, Multiple sclerosis patients |
Primary outcome
Diagnosis-related difference in EEG or TMS measurements
Time frame: Baseline recording
Differences in single or paired pulse TMS measures or time and/or frequency domain EEG characteristics between those within each patient cohort and controls
Prognosis-related EEG or TMS measurements
Time frame: Baseline recording
Patient cohort single or paired pulse TMS measures or time and/or frequency domain EEG characteristics which show significant correlation to cognitive, behavioural, motor and/or sensory task performance, to disease duration or to survival time
Diagnosis-related changes in EEG or TMS measurements
Time frame: Baseline to final visit assessed up to 2 years after baseline
Differences in rate of change (slope) across time of single or paired pulse TMS measures or time and/or frequency domain EEG characteristics between those within each patient cohort relative to controls
Prognosis-related changes in EEG or TMS measurements
Time frame: Baseline to final visit assessed up to 2 years after baseline
Rates of change (slope) across time of patient cohort single or paired pulse TMS measures or time and/or frequency domain EEG characteristics which show significant correlation to cognitive, behavioural, motor and/or sensory task performance, to disease duration or to survival time
2 secondary outcomes
Diagnosis-specific changes in EEG or TMS measurements
Time frame: Baseline to final visit assessed up to 2 years after baseline
Diagnosis-specific difference in EEG or TMS measurements
Time frame: Baseline recording
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2021.
- Results publication: PubMed 30735860McMackin R, Dukic S, Broderick M, Iyer PM, Pinto-Grau M, Mohr K, Chipika R, Coffey A, Buxo T, Schuster C, Gavin B, Heverin M, Bede P, Pender N, Lalor EC, Muthuraman M, Hardiman O, Nasseroleslami B. Dysfunction of attention switching networks in amyotrophic lateral sclerosis. Neuroimage Clin. 2019;22:101707. doi: 10.1016/j.nicl.2019.101707. Epub 2019 Feb 2.
- Results publication: PubMed 31348605Dukic S, McMackin R, Buxo T, Fasano A, Chipika R, Pinto-Grau M, Costello E, Schuster C, Hammond M, Heverin M, Coffey A, Broderick M, Iyer PM, Mohr K, Gavin B, Pender N, Bede P, Muthuraman M, Lalor EC, Hardiman O, Nasseroleslami B. Patterned functional network disruption in amyotrophic lateral sclerosis. Hum Brain Mapp. 2019 Nov 1;40(16):4827-4842. doi: 10.1002/hbm.24740. Epub 2019 Jul 26.
- Results publication: PubMed 32318719McMackin R, Dukic S, Costello E, Pinto-Grau M, Fasano A, Buxo T, Heverin M, Reilly R, Muthuraman M, Pender N, Hardiman O, Nasseroleslami B. Localization of Brain Networks Engaged by the Sustained Attention to Response Task Provides Quantitative Markers of Executive Impairment in Amyotrophic Lateral Sclerosis. Cereb Cortex. 2020 Jul 30;30(9):4834-4846. doi: 10.1093/cercor/bhaa076.
- Results publication: PubMed 33395671McMackin R, Dukic S, Costello E, Pinto-Grau M, Keenan O, Fasano A, Buxo T, Heverin M, Reilly R, Pender N, Hardiman O, Nasseroleslami B. Sustained attention to response task-related beta oscillations relate to performance and provide a functional biomarker in ALS. J Neural Eng. 2021 Feb 25;18(2). doi: 10.1088/1741-2552/abd829.
- Results publication: PubMed 28861032Iyer PM, Mohr K, Broderick M, Gavin B, Burke T, Bede P, Pinto-Grau M, Pender NP, McLaughlin R, Vajda A, Heverin M, Lalor EC, Hardiman O, Nasseroleslami B. Mismatch Negativity as an Indicator of Cognitive Sub-Domain Dysfunction in Amyotrophic Lateral Sclerosis. Front Neurol. 2017 Aug 15;8:395. doi: 10.3389/fneur.2017.00395. eCollection 2017.
- Results publication: PubMed 29136131Nasseroleslami B, Dukic S, Broderick M, Mohr K, Schuster C, Gavin B, McLaughlin R, Heverin M, Vajda A, Iyer PM, Pender N, Bede P, Lalor EC, Hardiman O. Characteristic Increases in EEG Connectivity Correlate With Changes of Structural MRI in Amyotrophic Lateral Sclerosis. Cereb Cortex. 2019 Jan 1;29(1):27-41. doi: 10.1093/cercor/bhx301.
- Results publication: PubMed 26091258Iyer PM, Egan C, Pinto-Grau M, Burke T, Elamin M, Nasseroleslami B, Pender N, Lalor EC, Hardiman O. Functional Connectivity Changes in Resting-State EEG as Potential Biomarker for Amyotrophic Lateral Sclerosis. PLoS One. 2015 Jun 19;10(6):e0128682. doi: 10.1371/journal.pone.0128682. eCollection 2015.
- Individual participant dataSharing planned: Yes. Raw data from this study may be made available in anonymized form upon request from qualified investigators subject to the approval by the Data Protection Office (DPO) and Office of Corporate Partnership and Knowledge Exchanges (OCPKE) in Trinity College Dublin, the University of Dublin.
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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.
Orla Hardiman, BSc MB BCh BAO MD FRCPI FAAN principal investigator
Academic Unit of Neurology, Trinity College Dublin, The University of Dublin
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 Amyotrophic Lateral Sclerosis and Frontotemporal Dementia, run by University of Dublin, Trinity College at 1 site in Ireland.
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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 8 Jun 2021. 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 Ireland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Orla Hardiman, BSc MB BCh BAO MD FRCPI FAAN (+353 1 896 4497, hardimao@tcd.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis-related difference in EEG or TMS measurements (time frame: Baseline recording). The study lists 4 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 NCT04918251, which also lists 7 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 8 Jun 2021; AzTrials last refreshed its copy on 7 Nov 2026.