Remote Home Assessment of Patients With Amyotrophic Lateral Sclerosis (RHAALS)

• ClinicalTrials.gov Identifier: NCT06046599
• Recruitment Status: Recruiting
• First Posted: September 21, 2023
• Last Update Posted: September 21, 2023
• Sponsor: King's College London
• Collaborators: Imperial College London; King's College Hospital NHS Trust
• Information provided by (Responsible Party): King's College London

Tracking Information

• First Submitted Date: August 29, 2023
• First Posted Date: September 21, 2023
• Last Update Posted Date: September 21, 2023
• Actual Study Start Date: October 24, 2022
• Estimated Primary Completion Date: February 1, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 13, 2023)

EMG activity [ Time Frame: 1 year ]

Number of fasciculations from electromyography

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: September 13, 2023)

• Nocturnal Respiration [ Time Frame: 1 year ]
  Respiratory rate recorded from an under mattress sensor
• Nocturnal heart rate [ Time Frame: 1 year ]
  Heart rate recorded from an under mattress sensor
• Household movement [ Time Frame: 1 year ]
  Movement within the home collected from passive infrared sensors
• Sleep stage ratios [ Time Frame: 1 year ]
  Awake periods, light sleep, deep sleep and rapid eye movement sleep recorded from an under mattress sensor.
• Blood pressure [ Time Frame: 1 year ]
  Blood pressure recorded from a wireless internet enabled blood pressure monitor
• Blood oxygen saturation [ Time Frame: 1 year ]
  Blood oxygen saturation recorded from a smart watch
• Heart beat irregularity [ Time Frame: 1 year ]
  R wave cycle count from electrocardiogram within smart watch
• Temperature [ Time Frame: 1 year ]
  Recorded from an internet enabled thermometer
• Weight [ Time Frame: 1 year ]
  Recorded from smart scales
• Step count [ Time Frame: 1 year ]
  Step count recorded from a smart watch

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Remote Home Assessment of Patients With Amyotrophic Lateral Sclerosis
• Official Title: Remote Home Assessment of Patients With Amyotrophic Lateral Sclerosis

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.

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 one available drug for ALS, which offers only a small increase to survival by two to three months. The discovery of new drugs for ALS is difficult due to a lack of objective measures that can be used to track disease progression. Consequently, there is a huge need to discover measures that can reliably track ALS over time, which can then be included in clinical trials to speed up drug discovery.

Muscle twitches are a distinctive characteristic present in all patients with ALS. These muscle twitches can be seen at the surface of the skin and can be detected accurately with electromyography (EMGs). We predict that these muscle twitches will provide a sensitive measure of disease progression.

Due to large dropout rates caused by travelling to and from the hospital, we have built and validated a compact high-density EMG device that sits on the surface of the skin to facilitate repeated assessments from patients' homes. This small device is a tenth of the cost of current devices and has been demonstrated to safely and effectively record muscle twitches. The EMG will be integrated into a digital remote home monitoring platform called Minder. Minder is an established platform for recording internet-enabled medical devices and sensors from within a patient's home.

This study aims to establish a home-based digital measure that can track disease progression in patients with ALS. We will recruit 20 patients with ALS from King's Motor Nerve Clinic. Patients will participate in the study for 12-months and will undergo continuous monitoring through the digital monitoring platform alongside regular EMG recordings.

• Study Type: Observational
• Study Design: Observational Model: Case-Only; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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
• Condition: Amyotrophic Lateral Sclerosis
• Intervention: Not Provided

Study Groups/Cohorts

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.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: September 13, 2023): 20
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: February 1, 2024
• Estimated Primary Completion Date: February 1, 2024 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Mark A Crook-Rumsey, PhD; +44(0) 7850255865 ext +44; markcrook-rumsey@hotmail.co.uk

Contact: James Bashford, MD; 07876406551 ext +44; james.bashford@kcl.ac.uk

• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT06046599
• Other Study ID Numbers: 296187
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: King's College London
• Original Responsible Party: Same as current
• Current Study Sponsor: King's College London
• Original Study Sponsor: Same as current

Collaborators

• Imperial College London
• King's College Hospital NHS Trust

• Investigators: Not Provided
• PRS Account: King's College London
• Verification Date: August 2023