Remote Home Assessment of Patients With Amyotrophic Lateral Sclerosis

NCT06046599 | Unknown

• 1 other identifier: 296187
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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 questions it aims to answer are:

• Can we integrate a new muscle monitoring device into Imperial College London's home monitoring platform?
• Can we investigate and understand the relationship between muscle activity and measure of patient behaviour (e.g., patient movement), physiology (e.g., pulse/blood pressure variation) and sleep quality from the home?
• Can we establish a home-based multimodal biomarker that tracks the neurodegenerative process in ALS? Participants will have passive internet-of-things sensors and internet-enabled medical devices installed in their homes for one year. Some sensors will record automatically without any interaction from the participants, but some will require participants to engage with daily (e.g., blood pressure monitor) on their own or with the help of a study partner. Where possible, researchers will compare the collected data to other neurodegenerative diseases and healthy controls to understand differences over time.

Conditions

Amyotrophic Lateral Sclerosis

Outcome Measures

Primary Outcomes (1)

• EMG activity

  Number of fasciculations from electromyography

  1 year

Secondary Outcomes (10)

• Nocturnal Respiration

  1 year

• Nocturnal heart rate

  1 year

• Household movement

  1 year

• Sleep stage ratios

  1 year

• Blood pressure

  1 year

Study Arms (1)

Patients living with amyotrophic lateral sclerosis

Individuals with a known diagnosis of amyotrophic lateral sclerosis will be recruited from King's College Hospital's Motor Nerve Clinic. The cohort will contain 20 individuals and their study partners and will be part of the study for one year.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a diagnosis of amyotrophic lateral sclerosis recruited through King's College Hospital's Motor Nerve Clinic

You may qualify if:

• 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).

You may not qualify if:

• The study will recruit individuals with a recent diagnosis of ALS.
• 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).
• 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).

Sponsors & Collaborators

• King's College London: lead
• Imperial College London: collaborator
• King's College Hospital NHS Trust: collaborator

Study Sites (1)

King's College Hospital

London, SE5 9RS, United Kingdom

RECRUITING

Related Links

• KCL SPIQE group information
• Minder remote monitoring platform

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Mark A Crook-Rumsey, PhD

CONTACT

+44(0) 7850255865; markcrook-rumsey@hotmail.co.uk

James Bashford, MD

CONTACT

07876406551; james.bashford@kcl.ac.uk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: September 21, 2023
• Study Start: October 24, 2022
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: September 21, 2023

Record last verified: 2023-08

Locations

GB (1)