Impairments of Neuro-muscular Communication in Motor-Neuron Disease: A Bio-Marker for Early and Personalised Diagnosis

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Dublin, Trinity College

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 128 electrode electroencephalography (EEG), Bipolar surface electromyography (sEMG), High-density electromyography (HD-EMG)

    Procedure/Surgery

    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)

Treatment groups

400 Participants
are divided into 4 treatment groups
Group A: Controls1 intervention
Group B: Amyotrophic lateral sclerosis patients1 intervention
Group C: Postpoliomyelitis syndrome1 intervention
Group D: Spinal Muscular Atrophy1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline to final visit assessed up to 2 years after baseline
2

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.

Time frame
Baseline to final visit assesed up to 2 years after baseline

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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