Surface EMG and Ultrasound in MND

Not Applicable

Completed

• Conditions: Motor Neuron Disease
• Interventions: Device: High-density surface EMG; Device: Ultrasound

• Registration Number: NCT05314348
• Lead Sponsor: King's College Hospital NHS Trust

Brief Summary

Patients with motor neurone disease typically experience relentless motor decline and die within three years of symptom onset from respiratory muscle weakness. There are currently no effective therapies and the discovery of novel therapies is hampered by the lack of a sensitive disease biomarker. Consequently, there is a huge drive to discover novel biomarkers, which can reliably track disease progression over time. These can then be incorporated into clinical drug trials to expedite effective drug discovery.

Muscle fasciculations represent the hyperexcitability of diseased motor neurons and are almost universally present from the early stages of MND. We predict that the site, frequency and shape of fasciculations might provide a sensitive measure of disease progression in an individual.

We have been conducting a 12-month longitudinal study of 25 patients, performing high-density surface EMG every two months. We have validated an automated technique to process these large data sets. Ultrasound is widely used in clinical medicine to assess anatomical structure in a safe and non-invasive way. Dr Emma Hodson-Tole (Manchester Metropolitan University) and her group have been applying this to the analysis of fasciculations in healthy individuals and patients with MND.

This collaborative project will explore combining these two techniques simultaneously in patients with motor neuron disease and control subjects. The goal is to explore the nature of electro-mechanical coupling related to fasciculations and to determine whether any of these properties are pathophysiological. This would complement other studies from our two groups, investigating the natural history and potential utility of fasciculations as a biomarker of motor neuron health in MND.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-11
• Study First Submitted: 2019-08-20
• Primary Completion: 2019-12-01
• Study Completion: 2019-12-01
• Status Verified: 2022-03
• Study First Submitted QC: 2022-03-29
• Last Update Submitted: 2022-03-29
• Study First Posted: 2022-04-06
• Last Update Posted: 2022-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy controls	High-density surface EMG	High-density surface EMG Ultrasound
Healthy controls	Ultrasound	High-density surface EMG Ultrasound
Motor Neuron Disease	High-density surface EMG	High-density surface EMG Ultrasound
Motor Neuron Disease	Ultrasound	High-density surface EMG Ultrasound

Primary Outcome Measures

Name	Time	Method
Correlation between automated detection of fasciculations by two methods (high-density surface EMG and ultrasound)	Single time-point

Secondary Outcome Measures

Name	Time	Method
To assess the practical feasibility of using high-density surface EMG and ultrasound simultaneously in biceps and gastrocnemius.	Single time-point
To highlight potential biomarkers of disease related to the electromechanical coupling of fasciculations (e.g. latency between electrical and mechanical peaks).	Single time-point

Trial Locations

Locations (1)

King's College Hospital NHS Foundation Trust; 🇬🇧 London, United Kingdom