Remote monitoring of ALS patients at home

Remote Home Assessment of Patients With Amyotrophic Lateral Sclerosis

This study is testing a new way to monitor the health and symptoms of people with ALS at home using special devices to see how their condition changes over time.

Quick facts

• Study type: Observational
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: King's College London (Academic / other)
• Locations: 1 site (London)
• Trial ID: NCT06046599 on ClinicalTrials.gov

What this trial studies

This observational study aims to develop innovative methods for remotely monitoring the health and symptoms of individuals living with amyotrophic lateral sclerosis (ALS) from their homes. It will integrate a new muscle monitoring device into an established home monitoring platform, allowing for the collection of data on muscle activity, patient behavior, physiology, and sleep quality. Participants will have passive sensors and internet-enabled medical devices installed in their homes for one year, with some requiring daily engagement. The goal is to establish a home-based multimodal biomarker that can track the neurodegenerative process in ALS, addressing the need for reliable measures of disease progression.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older, diagnosed with ALS within the last 36 months, and capable of ambulation.

Not a fit: Patients who are wheelchair-bound or have a recent diagnosis of ALS may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective way to monitor ALS progression, potentially leading to improved treatment strategies.

How similar studies have performed: Other studies have shown promise in remote monitoring approaches for chronic conditions, but this specific integration of technology for ALS is relatively novel.

Eligibility criteria

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:

* 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.

Where this trial is running

London

• King's College Hospital — London, United Kingdom (Recruiting)

Study contacts

• Study coordinator: Mark A Crook-Rumsey, PhD

Conditions Amyotrophic Lateral Sclerosis