Impairments of Neuro-muscular Communication in Motor-Neuron Disease: A Bio-Marker for Early and Personalised Diagnosis
MotorMarker
1 other identifier
observational
400
1 country
1
Brief Summary
Motor neuron disease (MND) or ALS is a nervous system disease. ALS leads to a loss of movement ability that eventually leads to death. At the moment, there is no known treatment for ALS. Early diagnosis in individuals improves clinical care and facilitates timely entry into clinical trials. However, current methods for diagnosis are primarily clinical, and to date, no cost-effective biomarkers have been developed. Our objective is to identify a robust non-invasive neurophysiological-based system that can be used both as a biomarker of disease onset, and a measurement of progression using quantitative EEG and surface EMG (bipolar and high-density). The investigators postulate that analysing the joint recordings of EEG and EMG (bipolar or high-density) can give measures that better distinguish healthy people and ALS patient subgroups and that the findings can be developed as biomarkers of early diagnosis and disease progression.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2015
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
December 2, 2022
CompletedFirst Posted
Study publicly available on registry
December 23, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2027
December 23, 2022
December 1, 2022
11.3 years
December 2, 2022
December 21, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
EEG-EMG signatures for reliable and early distinction between healthy people and ALS patient subgroups (specifically ALS, PLS, PMA, and SMA).
Cortico-muscular coherence (CMC) during functional motor tasks.
Baseline to final visit assessed up to 2 years after baseline
EEG-EEG signatures for reliable and early distinction between healthy people and ALS patient subgroups (specially ALS, PLS, PMA, and SMA)
Cortico-cortical coherence during functional motor tasks.
Baseline to final visit assesed up to 2 years after baseline
Study Arms (4)
Controls
Individuals from the Irish population with no psychiatric, psychological, neurological or muscular disease diagnosis.
Amyotrophic lateral sclerosis patients
Individuals from the Irish population (Irish Motorneuron Disease Register) with possible/probable/definitive diagnosis of ALS.
Postpoliomyelitis syndrome
Individuals from the Irish population (Irish Motorneuron Disease Register) with postpoliomyelitis syndrome diagnosis.
Spinal Muscular Atrophy
Individuals from the Irish population (Irish Motorneuron Disease Register) with spinal muscular atrophy diagnosis.
Interventions
128 electrode EEG and 8 bipolar EMG or HD-EMG will be noninvasively recorded from electrodes placed in a montage over the scalp and arm muscles while the participant is resting or performing tasks designed to engage specific cortical networks of interest (cognitive, behavioural, motor and sensory)
Eligibility Criteria
MND (ALS, PLS, PMA, SMA, Polio or MS) patients will be recruited from the national MND/ALS register, an ongoing registry run in conjunction with Beaumont Hospital ALS clinic, run by Professor Orla Hardiman. Healthy controls will be recruited from the student population and age-matched controls from the general public, as well as a dataset of pre-consented healthy volunteers which is maintained at the Academic Unit of Neurology, Trinity College Dublin.
You may qualify if:
- Healthy Volunteers:
- age and gender-matched to patient groups
- the intact physical ability to take part in the experiment.
- Patients:
- Diagnosis of ALS, PLS, PMA, SMA, Polio or MS
- capable of providing informed consent.
You may not qualify if:
- Healthy Controls:
- History of neuromuscular
- neurological or active psychiatric disease disease
- history of reaction or allergy to recording environments, equipment and the recording gels.
- Patients:
- the presence of active psychiatric disease
- any medical condition associated with severe neuropathy (e.g. poorly controlled diabetes).
- History of reaction or allergy to recording environments, equipment and the recording gels.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Dublin, Trinity Collegelead
- Motor Neurone Disease Association, UKcollaborator
- Irish Research Council, IEcollaborator
- Research Motor Neuron, IEcollaborator
- Thierry Latran Foundation, FRcollaborator
- ALS Association, USAcollaborator
Study Sites (1)
Academic Unit of Neurology, Trinity College Dublin, The University of Dublin
Dublin, Leinster, Dublin 2, Ireland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Orla Hardiman, BSc MB BCh BAO MD FRCPI FAAN
Academic Unit of Neurology, Trinity College Dublin, The University of Dublin
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Neurology
Study Record Dates
First Submitted
December 2, 2022
First Posted
December 23, 2022
Study Start
October 1, 2015
Primary Completion (Estimated)
January 30, 2027
Study Completion (Estimated)
September 30, 2027
Last Updated
December 23, 2022
Record last verified: 2022-12
Data Sharing
- IPD Sharing
- Will not share