Non-invasive Spinal, Cortical, and Sensorimotor Biomarkers in Motor Neurone Disease (NCT06320444) | Clinical Trial Compass
UnknownNot Applicable
Non-invasive Spinal, Cortical, and Sensorimotor Biomarkers in Motor Neurone Disease
Ireland240 participantsStarted 2023-06-15
Plain-language summary
Substantial variability exists in the onset, and rate of degeneration across individuals with Motor Neurone Disease (MND) or Amyotrophic Lateral Sclerosis (ALS). This variability requires biomarkers that accurately classify and reliably track clinical subtypes as the disease progresses. Degeneration occurs in the brain and spinal cord, however, non-invasive diagnosis of spinal cord function remains highly challenging due to its unique alignment in spine. Disruption of complex spinal and cortical circuits that transmit and process neural signals for position sense and movement has not been adequately captured in the neurophysiological profiling of ALS patients. The overarching aim of this study is to reveal and quantify the extent of change in the sensorimotor integration and its potential contribution to network disruption in ALS.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
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Healthy Volunteers:
* age and gender matched to patient groups
* 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:
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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:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Biomarker of sensorimotor integration
Timeframe: Baseline to 2-years after baseline
2
Determination of the feasibility of sensorimotor signatures as reliable biomarkers of ALS
Timeframe: Baseline
3
Non-invasive recording of the SC functional neuro-electric activity