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Surface EMG and Ultrasound in MND

Primary Purpose

Motor Neuron Disease

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
High-density surface EMG
Ultrasound
Sponsored by
King's College Hospital NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Motor Neuron Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria for MND patients:

(i) Aged between 40 and 80 years of age inclusive, at the time of signing the informed consent.

(ii) Diagnosed with MND by a neurologist with expertise in MND. For subjects with bulbar onset there must be objective limb involvement of at least one limb. (iii) Diagnosed with MND within 24 months of symptom onset. (iv) Subjects must be ambulatory (i.e. must not be confined to a wheelchair). (v) Male and female subjects (vi) Capable of giving signed (or verbal consent or assent where applicable) informed consent as described in Protocol Section 9.2 which includes compliance with the requirements and restrictions listed in the consent form and in the protocol. (vii) Capable and willing to comply with the requirements of the protocol (either by themselves or with assistance).

Inclusion criteria for healthy controls (i) Aged between 40 and 80 years of age inclusive, at the time of signing the informed consent.

(ii) Male and female subjects (vi) Capable of giving signed (or verbal consent or assent where applicable) informed consent as described in Protocol Section 9.2 which includes compliance with the requirements and restrictions listed in the consent form and in the protocol. (vii) Capable and willing to comply with the requirements of the protocol

Exclusion criteria for MND patients:

(i) Neurological (other than the subject's MND) or non neurological co morbidities (e.g. joint disease, respiratory disease) which limit mobility.

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

(iii) Regionally restricted forms of MND, or other atypical variants:

  • Isolated corticobulbar pattern of MND with normal ambulation
  • Primary lateral sclerosis
  • Signs of chronic partial denervation restricted to a single limb
  • MND or parkinsonism dementia complex (iv) Subjects requiring mechanical ventilation (non invasive ventilation for sleep apnoea is allowed).

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

(vii) History of skin hypersensitivity to adhesives. (viii) Current participation in a clinical trial which in the opinion of the chief investigator might impact the objectives of this study.

Exclusion criteria for healthy participants:

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

(iii) History of skin hypersensitivity to adhesives. (iv) Current participation in a clinical trial which in the opinion of the chief investigator might impact the objectives of this study.

Sites / Locations

  • King's College Hospital NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Motor Neuron Disease

Healthy controls

Arm Description

High-density surface EMG Ultrasound

High-density surface EMG Ultrasound

Outcomes

Primary Outcome Measures

Correlation between automated detection of fasciculations by two methods (high-density surface EMG and ultrasound)

Secondary Outcome Measures

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

Full Information

First Posted
August 20, 2019
Last Updated
March 29, 2022
Sponsor
King's College Hospital NHS Trust
Collaborators
Manchester Metropolitan University
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1. Study Identification

Unique Protocol Identification Number
NCT05314348
Brief Title
Surface EMG and Ultrasound in MND
Official Title
Exploring the Electro-mechanical Coupling of Fasciculations in Motor Neuron Disease Using Surface Electromyography and Ultrasound: a Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
June 11, 2019 (Actual)
Primary Completion Date
December 1, 2019 (Actual)
Study Completion Date
December 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King's College Hospital NHS Trust
Collaborators
Manchester Metropolitan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Motor Neuron Disease

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
12 MND/ALS patients and 13 healthy controls to be assessed at a single time-point each
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Motor Neuron Disease
Arm Type
Active Comparator
Arm Description
High-density surface EMG Ultrasound
Arm Title
Healthy controls
Arm Type
Active Comparator
Arm Description
High-density surface EMG Ultrasound
Intervention Type
Device
Intervention Name(s)
High-density surface EMG
Intervention Description
High-density surface EMG for fasciculation detection
Intervention Type
Device
Intervention Name(s)
Ultrasound
Intervention Description
Ultrasound for fasciculation detection
Primary Outcome Measure Information:
Title
Correlation between automated detection of fasciculations by two methods (high-density surface EMG and ultrasound)
Time Frame
Single time-point
Secondary Outcome Measure Information:
Title
To assess the practical feasibility of using high-density surface EMG and ultrasound simultaneously in biceps and gastrocnemius.
Time Frame
Single time-point
Title
To highlight potential biomarkers of disease related to the electromechanical coupling of fasciculations (e.g. latency between electrical and mechanical peaks).
Time Frame
Single time-point

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria for MND patients: (i) Aged between 40 and 80 years of age inclusive, at the time of signing the informed consent. (ii) Diagnosed with MND by a neurologist with expertise in MND. For subjects with bulbar onset there must be objective limb involvement of at least one limb. (iii) Diagnosed with MND within 24 months of symptom onset. (iv) Subjects must be ambulatory (i.e. must not be confined to a wheelchair). (v) Male and female subjects (vi) Capable of giving signed (or verbal consent or assent where applicable) informed consent as described in Protocol Section 9.2 which includes compliance with the requirements and restrictions listed in the consent form and in the protocol. (vii) Capable and willing to comply with the requirements of the protocol (either by themselves or with assistance). Inclusion criteria for healthy controls (i) Aged between 40 and 80 years of age inclusive, at the time of signing the informed consent. (ii) Male and female subjects (vi) Capable of giving signed (or verbal consent or assent where applicable) informed consent as described in Protocol Section 9.2 which includes compliance with the requirements and restrictions listed in the consent form and in the protocol. (vii) Capable and willing to comply with the requirements of the protocol Exclusion criteria for MND patients: (i) Neurological (other than the subject's MND) or non neurological co morbidities (e.g. joint disease, respiratory disease) which limit mobility. (ii) Clinically significant cognitive impairment in the opinion of the investigator or lacking capacity in accordance with the Mental Capacity Act (2005). (iii) Regionally restricted forms of MND, or other atypical variants: Isolated corticobulbar pattern of MND with normal ambulation Primary lateral sclerosis Signs of chronic partial denervation restricted to a single limb MND or parkinsonism dementia complex (iv) Subjects requiring mechanical ventilation (non invasive ventilation for sleep apnoea is allowed). (v) 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. (vi) Presence of an active implantable cardiac medical device (e.g., pacemaker or implantable cardioverter defibrillator) or at a high risk for needing external defibrillation. (vii) History of skin hypersensitivity to adhesives. (viii) Current participation in a clinical trial which in the opinion of the chief investigator might impact the objectives of this study. Exclusion criteria for healthy participants: (i) 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. (ii) Presence of an active implantable cardiac medical device (e.g., pacemaker or implantable cardioverter defibrillator) or at a high risk for needing external defibrillation. (iii) History of skin hypersensitivity to adhesives. (iv) Current participation in a clinical trial which in the opinion of the chief investigator might impact the objectives of this study.
Facility Information:
Facility Name
King's College Hospital NHS Foundation Trust
City
London
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31078984
Citation
Bashford J, Wickham A, Iniesta R, Drakakis E, Boutelle M, Mills K, Shaw C. SPiQE: An automated analytical tool for detecting and characterising fasciculations in amyotrophic lateral sclerosis. Clin Neurophysiol. 2019 Jul;130(7):1083-1090. doi: 10.1016/j.clinph.2019.03.032. Epub 2019 Apr 19. Erratum In: Clin Neurophysiol. 2020 Jan;131(1):350.
Results Reference
background
PubMed Identifier
30857760
Citation
Bibbings K, Harding PJ, Loram ID, Combes N, Hodson-Tole EF. Foreground Detection Analysis of Ultrasound Image Sequences Identifies Markers of Motor Neurone Disease across Diagnostically Relevant Skeletal Muscles. Ultrasound Med Biol. 2019 May;45(5):1164-1175. doi: 10.1016/j.ultrasmedbio.2019.01.018. Epub 2019 Mar 8.
Results Reference
background

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Surface EMG and Ultrasound in MND

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