NCT05713474

Brief Summary

The purpose of this small-scale exploratory study is to bridge the knowledge gap between the bench testing and the design of potential future confirmative studies. Identifying and evaluating MicroEMG measurement parameters in this exploratory manner is a necessary step to evaluate its usability and design, and determine whether the microEMG system may be suitable for in-house use after further confirmative testing.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

February 6, 2023

Completed
1.2 years until next milestone

Study Start

First participant enrolled

April 26, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

May 13, 2024

Status Verified

May 1, 2024

Enrollment Period

1.7 years

First QC Date

January 12, 2023

Last Update Submit

May 10, 2024

Conditions

Electromyography

Outcome Measures

Primary Outcomes (2)

  • List of potential EMG parameters to inform future diagnostic marker evaluation studies.

    extracted from EEG recordings

    1 study day

  • Report of tested and potential vs. disregarded diagnostic markers for MicroEMG.

    extracted from EEG recordings

    1 study day

Secondary Outcomes (2)

  • Summary of health care and patient experience with MicroEMG system.

    1 study day

  • Potential changes to the system or the examination procedure.

    1 study day

Study Arms (5)

Healthy controls

Diagnostic Test: Diagnostic EMG exam with microEMGDiagnostic Test: Conventional EMG

Patients previously diagnosed with motor neurone disease

Diagnostic Test: Diagnostic EMG exam with microEMGDiagnostic Test: Conventional EMG

Patients previously diagnosed with sarcopenia

Diagnostic Test: Diagnostic EMG exam with microEMGDiagnostic Test: Conventional EMG

Patients previously diagnosed with post-polio syndrome

Diagnostic Test: Diagnostic EMG exam with microEMGDiagnostic Test: Conventional EMG

Patients previously diagnosed with myasthenia gravis

Diagnostic Test: Diagnostic EMG exam with microEMGDiagnostic Test: Conventional EMG

Interventions

Diagnostic EMG exam with microEMGDIAGNOSTIC_TEST

Diagnostic EMG exam with microEMG

Healthy controlsPatients previously diagnosed with motor neurone diseasePatients previously diagnosed with myasthenia gravisPatients previously diagnosed with post-polio syndromePatients previously diagnosed with sarcopenia
Conventional EMGDIAGNOSTIC_TEST

Diagnostic EMG exam with conventional EMG

Healthy controlsPatients previously diagnosed with motor neurone diseasePatients previously diagnosed with myasthenia gravisPatients previously diagnosed with post-polio syndromePatients previously diagnosed with sarcopenia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with neuromuscular diseases - in particular, motor neurone disease, sarcopenia, post-polio syndrome, and myasthenia gravis - as well as healthy controls.

You may qualify if:

  • For each of the five groups, six participants will be recruited, adding up to a total of 30 participants.

You may not qualify if:

  • cardiac pacemakers or defibrillator implants.
  • alternative neurological disorders likely to affect the results of an EMG examination.
  • lymphedema or dialysis fistula in the body region to be studied with EMG.
  • patients taking clotting inhibitor (such as warfarin or direct oral anticoagulants).
  • clotting disorder (such as haemophilia or low platelets).
  • participants unable to consent in English where a translator is not available.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RVI - Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne, United Kingdom

RECRUITING

Study Officials

  • Roger Whittaker

    Newcastle University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Katrin Bangel

CONTACT

01912083543Katrin.Bangel@nhs.net

Roger Whittaker

CONTACT

roger.whittaker@newcastle.ac.uk

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2023

First Posted

February 6, 2023

Study Start

April 26, 2024

Primary Completion

January 1, 2026

Study Completion

January 1, 2026

Last Updated

May 13, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)