About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
age and gender-matched to patient groups
the intact physical ability to take part in the experiment.
Diagnosis of ALS, PLS, PMA, SMA, Polio or MS
capable of providing informed consent.
Disqualifiers
History of neuromuscular
neurological or active psychiatric disease disease
history of reaction or allergy to recording environments, equipment and the recording gels.
the presence of active psychiatric disease
Trial population
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.
Trial design
Cohort
Prospective
Treatments tested in this trial
128 electrode electroencephalography (EEG), Bipolar surface electromyography (sEMG), High-density electromyography (HD-EMG)
Procedure/Surgery128 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)
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
Sponsors and contacts
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University of Dublin, Trinity College
Lead sponsor
Motor Neurone Disease Association, UK
Collaborator
Irish Research Council, IE
Collaborator
Research Motor Neuron, IE
Collaborator
Thierry Latran Foundation, FR
Collaborator
ALS Association, USA
Collaborator