Amyotrophic Lateral SclerosisRHAALSNCT06046599
Remote Home Assessment of Patients With Amyotrophic Lateral Sclerosis
An observational study of Amyotrophic Lateral Sclerosis, run by King's College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Oct 2022to 1 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a diagnosis of amyotrophic lateral sclerosis recruited through King's College Hospital's Motor Nerve Clinic
Who may be able to join
- 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).
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- 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).
Who cannot join
- The study will recruit individuals with a recent diagnosis of ALS.
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
King's College Hospital
London, SE5 9RS
Chris Shaw, Professor, +44(0) 20 7836 5454 ext. 85180, chris.shaw@kcl.ac.uk
About this study
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.
Read the 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.
- Conditions
- Amyotrophic Lateral Sclerosis
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
EMG activity
Number of fasciculations from electromyography
Measured: 1 year
Secondary outcomes (10)
Nocturnal Respiration
Respiratory rate recorded from an under mattress sensor
Measured: 1 year
Nocturnal heart rate
Heart rate recorded from an under mattress sensor
Measured: 1 year
Household movement
Movement within the home collected from passive infrared sensors
Measured: 1 year
Sleep stage ratios
Awake periods, light sleep, deep sleep and rapid eye movement sleep recorded from an under mattress sensor.
Measured: 1 year
Blood pressure
Blood pressure recorded from a wireless internet enabled blood pressure monitor
Measured: 1 year
Blood oxygen saturation
Blood oxygen saturation recorded from a smart watch
Measured: 1 year
Heart beat irregularity
R wave cycle count from electrocardiogram within smart watch
Measured: 1 year
Temperature
Recorded from an internet enabled thermometer
Measured: 1 year
Weight
Recorded from smart scales
Measured: 1 year
Step count
Step count recorded from a smart watch
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start24 Oct 2022
- Primary completion1 Feb 2024 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Imperial College London, King's College Hospital NHS Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06046599
- Sponsor's protocol ID
- 296187
- Acronym
- RHAALS
- Status last verified
- Aug 2023
- First submitted
- 29 Aug 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Home Assessment of Patients With Amyotrophic Lateral Sclerosis
- ClinicalTrials.gov ID
- NCT06046599
- Acronym / sponsor ID
- RHAALS / 296187
- Conditions
- Amyotrophic Lateral Sclerosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Imperial College London, King's College Hospital NHS Trust
- Study start
- 24 Oct 2022 (actual)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a diagnosis of amyotrophic lateral sclerosis recruited through King's College Hospital's Motor Nerve Clinic
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (14 listed)
- The study will recruit individuals with a recent diagnosis of ALS.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
EMG activity
Time frame: 1 year
Number of fasciculations from electromyography
10 secondary outcomes
Nocturnal Respiration
Time frame: 1 year
Nocturnal heart rate
Time frame: 1 year
Household movement
Time frame: 1 year
Sleep stage ratios
Time frame: 1 year
Blood pressure
Time frame: 1 year
Blood oxygen saturation
Time frame: 1 year
Heart beat irregularity
Time frame: 1 year
Temperature
Time frame: 1 year
Weight
Time frame: 1 year
Step count
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- KCL SPIQE group informationLink provided by the sponsor.
- Minder remote monitoring platformLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amyotrophic Lateral Sclerosis, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mark A Crook-Rumsey, PhD (+44(0) 7850255865 ext. +44, markcrook-rumsey@hotmail.co.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EMG activity (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.