Status:
COMPLETED
Serial Fasciculation Measurements in Motor Neurone Disease
Lead Sponsor:
King's College Hospital NHS Trust
Conditions:
Motor Neuron Disease
Benign Fasciculation-Cramp Syndrome
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Patients with motor neurone disease (MND) typically experience relentless motor decline and die within three years of symptom onset from respiratory muscle weakness. There are currently no effective t...
Eligibility Criteria
Inclusion
- Inclusion criteria for MND patients:
- (i) Aged between 40 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 24 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).
- Inclusion criteria for Benign Fasciculation Syndrome (BFS) patients:
- (i) Aged between 18 and 80 years of age inclusive, at the time of signing the informed consent.
- (ii) Diagnosed with BFS by a neurologist with expertise in motor nerve disorders.
- (iii) 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 for MND patients:
- (i) Neurological (other than the subject's MND) or non-neurological co-morbidities (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.
- Exclusion criteria for Benign Fasciculation Syndrome patients:
- (i) Significant diagnostic uncertainty, whereby motor neurone disease remains a possible differential diagnosis.
- (ii) 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.
- (iii) Presence of an active implantable cardiac medical device (e.g., pacemaker or implantable cardioverter-defibrillator) or at a high risk for needing external defibrillation.
- (iv) History of skin hypersensitivity to adhesives. (v) Current participation in a clinical trial which in the opinion of the chief investigator might impact the objectives of this study.
Exclusion
Key Trial Info
Start Date :
July 6 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2019
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT03809845
Start Date
July 6 2017
End Date
March 1 2019
Last Update
August 21 2019
Active Locations (1)
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1
King's College Hospital NHS Foundation Trust
London, United Kingdom