MONITOR ALS

Non-invasive MONITORing of human motoneuron properties in Amyotrophic Lateral Sclerosis progression

UK Chief Investigator

Jakob Skarabot

Research summary

A lot is still unknown about the progression of Amyotrophic Lateral Sclerosis (ALS), and widely effective therapies are still lacking. To understand disease and advance therapeutics it is important to develop suitable biomarkers. In ALS, an attractive biomarker candidate is the dysfunction in motoneuron activity. In clinical drug trials, tracking improvements often involves invasive procedures with poorer patient tolerance. Here, we propose to track and study motoneuron dysfunction in ALS without using needles. Specifically, we will record muscle activity with large sensors placed on the skin. These recordings will then be analysed using powerful computer algorithms that detect motoneuron dysfunction. We plan to do these recordings in ALS patients every three months for half a year. This will give us a detailed look into how motoneurons change their activity with ALS. We anticipate that this entirely non-invasive approach will significantly improve our understanding of ALS progression. It will allow us to develop a tool that can be used in clinical trials for cheaper costs so that many more therapeutics may be tested. It also has the potential to be used for earlier detection of ALS - this is critically needed for patients to make treatment more effective.

Current status

Open to recruitment

Recruitment target

60 participants in total, broken down into:

• 30 people living with ALS

• 30 neurologically healthy controls

Click here to see how many patients have been recruited into this study to date (external link to the NIHR public study search) 

Recruitment groups

Patients with MND

Locations

• Loughborough University, Principal Investigator: Dr Jakob Skarabot

• Nottingham (Queens Medical Centre), Principal Investigator: Erica Littleworth

Contact details

Email Gemma Brownbill: g.brownbill@lboro.ac.uk

Key dates

Recruitment opening date: 08 October 2025

Planned recruitment end date: 31 December 2026

Inclusion / exclusion criteria

Inclusion criteria for participants with ALS: 

1. Clinically confirmed diagnosis of ALS within the last 24 months (for patients with bulbar onset, they must be symptomatic in at least one limb)

2. Age 18-90 years

3. Able to consent

4. Able and willing to comply with the requirements of the protocol (either by themselves or with assistance)

Inclusion criteria for the control group: 

1. Age 18-90 years

2. Able to consent

3. Able and willing to comply with the requirements of the protocol

Exclusion criteria for participants with ALS:

1. Non-ALS related neurological comorbidities

2. Non-neurological comorbidities, including joint disease, respiratory disease, active skin ulceration or infection

3. History or current evidence of clinically significant uncontrolled disease which would put the safety of participation at risk

4. Regionally restricted forms of Motor Neurone Disease, or other atypical variants including primary lateral sclerosis, signs of chronic partial denervation restricted to a single limb, parkinsonism dementia complex

5. Requirement for mechanical ventilation for > 20 hours a day (n.b. does not include only non-invasive ventilation during sleep)

6. Presence of an active implantable cardiac medical device (e.g., pacemaker or implantable cardioverter defibrillator) or at a high risk for needing external defibrillation

7. Current participation in a study with conflicting therapies/outcomes

8. History of skin hypersensitivity to adhesives

9. Clinically significant cognitive impairment in the opinion of the investigator or lacking capacity in accordance with the Mental Capacity Act (2005).    

Exclusion criteria for the control group: 

1. Any neurological comorbidities

2. Non-neurological comorbidities, including joint disease, respiratory disease, active skin ulceration or infection

3. History or current evidence of clinically significant uncontrolled disease which would put the safety of participation at risk

4. Presence of an active implantable cardiac medical device (e.g., pacemaker or implantable cardioverter defibrillator) or at a high risk for needing external defibrillation

5. Current participation in a study with conflicting therapies/outcomes

6. History of skin hypersensitivity to adhesives

7. Clinically significant cognitive impairment in the opinion of the investigator or lacking capacity in accordance with the Mental Capacity Act (2005).

Funder

The Darby Rimmer MND Foundation

Sponsor

Loughborough University

Study design

Observational, cohort study