Status:
UNKNOWN
Remote Home Assessment of Patients With Amyotrophic Lateral Sclerosis
Lead Sponsor:
King's College London
Collaborating Sponsors:
Imperial College London
King's College Hospital NHS Trust
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
18+ years
Brief Summary
The goal of this observational study is the develop new ways of remotely monitoring the health and symptoms of people living with amyotrophic lateral sclerosis from within their homes. The main questi...
Detailed Description
Amyotrophic lateral sclerosis (ALS), is a neurodegenerative disease that affects nerve cells causing loss of muscle control. Patients with ALS often die within three years of diagnosis. There is only ...
Eligibility Criteria
Inclusion
- Aged 18 years of age or above at the time of signing the informed consent.
- Diagnosed with ALS by a neurologist with expertise in ALS (Brooks et al., 2000). For subjects with bulbar onset there must be objective limb involvement of at least one limb.
- Diagnosed with ALS within 36 months of symptom onset.
- Subjects must be ambulatory (i.e., must not be confined to a wheelchair).
- Capable of giving signed informed consent.
- Capable and willing to comply with the requirements of the protocol (either by themselves or with assistance).
Exclusion
- The study will recruit individuals with a recent diagnosis of ALS.
- Inclusion criteria:
- Aged 18 years of age or above at the time of signing the informed consent.
- Diagnosed with ALS by a neurologist with expertise in ALS (Brooks et al., 2000). For subjects with bulbar onset there must be objective limb involvement of at least one limb.
- Diagnosed with ALS within 36 months of symptom onset.
- Subjects must be ambulatory (i.e., must not be confined to a wheelchair).
- Capable of giving signed informed consent.
- Capable and willing to comply with the requirements of the protocol (either by themselves or with assistance).
- Exclusion criteria:
- Neurological (other than the subject's ALS) or non-neurological co-morbidities (e.g., joint disease, respiratory disease) which limit mobility.
- Clinically significant cognitive impairment in the opinion of the investigator or lacking capacity in accordance with the Mental Capacity Act (2005).
- Regionally restricted forms of ALS, or other atypical variants:
- Isolated corticobulbar pattern of ALS with normal ambulation
- Primary lateral sclerosis
- Signs of chronic partial denervation restricted to a single limb
- ALS or parkinsonism dementia complex
- Subjects requiring mechanical ventilation (non-invasive ventilation for sleep apnoea is allowed).
- 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.
- Presence of an active implantable cardiac medical device (e.g., pacemaker or implantable cardioverter-defibrillator) or at a high risk for needing external defibrillation.
- History of skin hypersensitivity to adhesives.
- Current participation in a clinical trial which in the opinion of the chief investigator might impact the objectives of this study.
- Does not have Wifi/stable internet in the home.
Key Trial Info
Start Date :
October 24 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06046599
Start Date
October 24 2022
End Date
February 1 2024
Last Update
September 21 2023
Active Locations (1)
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1
King's College Hospital
London, United Kingdom, SE5 9RS