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Recruiting Observational

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

NCT05663008 · tracked via the Priya Life Science Ireland tracker
Phase
Observational
Started
2015-10-01
Last updated
2022-12-23

Condition(s) studied

ALS (Amyotrophic Lateral Sclerosis)Postpoliomyelitis SyndromeSpinal Muscular Atrophy

Investigational drug(s) / intervention(s)

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

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: 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. Exclusion Criteria: 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.

Primary outcome measure(s)

  • EEG-EMG signatures for reliable and early distinction between healthy people and ALS patient subgroups (specifically ALS, PLS, PMA, and SMA). — Baseline to final visit assessed up to 2 years after baseline
    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) — Baseline to final visit assesed up to 2 years after baseline
    Cortico-cortical coherence during functional motor tasks.

Trial sites (1)

FacilityCityRegionStatus
Academic Unit of Neurology, Trinity College Dublin, The University of Dublin Dublin Leinster Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05663008 on ClinicalTrials.gov ↗ ← All trials in Ireland