Last updated: September 13, 2023
Sponsor: King's College London
Overall Status: Active - Recruiting
Phase
N/A
Condition
Amyotrophic Lateral Sclerosis (Als)
Myasthenia Gravis (Chronic Weakness)
Scar Tissue
Treatment
N/AClinical Study ID
NCT06046599
296187
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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). Forsubjects with bulbar onset there must be objective limb involvement of at least onelimb.
- 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 bythemselves or with assistance).
Exclusion
Exclusion Criteria:
- 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). Forsubjects with bulbar onset there must be objective limb involvement of at least onelimb.
- 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 bythemselves 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 orlacking 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 apnoeais 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 riskthrough participation or impact the study assessments or endpoints.
- Presence of an active implantable cardiac medical device (e.g., pacemaker orimplantable cardioverter-defibrillator) or at a high risk for needing externaldefibrillation.
- History of skin hypersensitivity to adhesives.
- Current participation in a clinical trial which in the opinion of the chiefinvestigator might impact the objectives of this study.
- Does not have Wifi/stable internet in the home.
Study Design
Total Participants: 20
Study Start date:
October 24, 2022
Estimated Completion Date:
February 01, 2024
Study Description
Connect with a study center
King's College Hospital
London, SE5 9RS
United KingdomActive - Recruiting
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