Remote surface EMG in MND

Study titleHome monitoring in motor neuron disease using remote surface electromyography: a feasibility study
UK Chief InvestigatorProf Chris Shaw
Research summaryPatients with motor neurone disease typically experience relentless motor decline and die within three years of symptom onset from respiratory muscle weakness. There are currently no effective therapies and the discovery of novel therapies is hampered by the lack of a sensitive disease biomarker. Consequently, there is a huge drive to discover novel biomarkers, which can reliably track disease progression over time. These can then be incorporated into clinical drug trials to expedite effective drug discovery. Muscle fasciculations represent the hyperexcitability of diseased motor neurons and are almost universally present from the early stages of MND. We predict that the site, frequency and shape of fasciculations might provide a sensitive measure of disease progression in an individual. We have been conducting a 12-month longitudinal study of 25 patients, performing high-density surface EMG every two months. We have validated an automated technique to process these large data sets (Bashford et al 2019). Due to a significant dropout rate (9/25) in the study owing to patients' inability to travel to and from the hospital for each assessment, we wish to introduce remote home monitoring in the long run. This would enable us to capture key data at a point when patients are becoming too disabled to attend the hospital. Our current recording equipment is expensive and bulky, lacking the portability for widespread use in patients' homes. In collaboration with bioengineers at Imperial College London, we have built and customised a more compact device called PANACEA. This is under a tenth of the cost of our current device and is no larger than an average broadband router. The aim of this study is to test the feasibility of this device, comparing it with our current equipment to ensure its safety, practicability and efficacy at recording fasciculations.
Inclusion/exclusion criteriaInclusion Criteria:
(i) Aged between 18 and 80 years of age inclusive, at the time of signing the informed consent. (ii) Diagnosed with MND by a neurologist with expertise in MND.(20) For subjects with bulbar onset there must be objective limb involvement of at least one limb. (iii) Diagnosed with MND within 36 months of symptom onset. (iv) Subjects must be ambulatory (i.e. must not be confined to a wheelchair). (v) Male and female subjects (vi) Capable of giving signed informed consent (vii) Capable and willing to comply with the requirements of the protocol (either by themselves or with assistance).
Exclusion Criteria:
(i) Neurological (other than the subject’s MND) or non ­neurological co­morbidities (e.g. joint disease, respiratory disease) which limit mobility.
(ii) Clinically significant cognitive impairment in the opinion of the investigator or lacking capacity in accordance with the Mental Capacity Act (2005).
(iii) Regionally restricted forms of MND, or other atypical variants: • Isolated corticobulbar pattern of MND with normal ambulation • Primary lateral sclerosis • Signs of chronic partial denervation restricted to a single limb • MND or parkinsonism dementia complex
(iv) Subjects requiring mechanical ventilation (non ­invasive ventilation for sleep apnoea is allowed).
(v) Historical or current evidence of clinically significant uncontrolled disease which, in the opinion of the chief investigator, would put the safety of the subject at risk through participation or impact the study assessments or endpoints.
(vi) Presence of an active implantable cardiac medical device (e.g., pacemaker or implantable cardioverter ­defibrillator) or at a high risk for needing external defibrillation.
(vii) History of skin hypersensitivity to adhesives.
(viii) Current participation in a clinical trial which in the opinion of the chief investigator might impact the objectives of this study.
Current statusActive - Recruitment
LocationsKing’s College Hospital, London
Contact detailsJames Bashford - Research Activity Co-ordinator
james.bashford@kcl.ac.uk
Recruitment group(s)Participant with the relevant condition
Recruitment target(s)6 participants (UK)
Key datesActual opening date: 30 June 2020
First participant UK: 01 June 2021
Planned study completion date:
Funder(s)Motor Neurone Disease Association (MNDA)
Medical Research Council (Clinical Research Training Fellowship)
SponsorKing's College London
Study designObservational
Intervention (if applicable)
Phase (if applicable)
Outcome measuresEffect of recording device on median noise level as a measure of data quality.
Publications / Results reports
Participant Information Sheet