Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT05713474 |
Other study ID # |
uEMG |
Secondary ID |
28039122-NS-0097 |
Status |
Not yet recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
March 1, 2023 |
Est. completion date |
January 1, 2026 |
Study information
Verified date |
January 2023 |
Source |
Newcastle University |
Contact |
Katrin Bangel |
Phone |
01912083543 |
Email |
Katrin.Bangel[@]nhs.net |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial 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.
Description:
About this study We have developed a completely new multi-electrode electromyography system
(MicroEMG) that we want to test in this study. It records muscle activity from multiple
recording points in the muscle at once. We believe that this will increase the sensitivity of
the technique in diagnosing muscle disease, reduce the time taken, and be more comfortable
for patients. However, to prove whether this is the case we first need to understand the how
the recorded signals of the new MicroEMG look like in different patient groups.
Background:
Why are we doing this study? Electromyography (EMG) is an essential diagnostic test for nerve
and muscle diseases. Cells in the muscle generate electric potentials when they are
activated. This activity can be measured by the EMG. Based on those 'patterns', experts can
detect medical abnormalities, such as muscle or nerve disorders.
EMG involves inserting a thin metal needle electrode through the skin into a muscle. It
records changes in the pattern of electrical signals produced by the muscle fibres.
In conventional EMG only a single recording surface at the tip of the needle is used and
therefore only small part of muscle can be examined.
We developed a new EMG device called MicroEMG. It uses a novel type of electrode that can
examine the muscle in more detail. As it records activity from several different points at
the muscle at once it can produce an electrical image (rather than an abstract signal). This
way a large volume of muscle can be recorded simultaneously with less movement and discomfort
for the patient.
What is the goal of this study? Patients with a disease known to affect the nerves or the
muscles typically would be tested with conventional EMG. Some diseases are linked to a
specific 'diagnostic pattern' in the EMG that guides the specialist's diagnosis.
We do not know these pattern for MicroEMG yet. In this study we want to look at how
measurements with the new MicroEMG look like in patients with neuromuscular disease. Each
patient will undergo recordings from identical muscles using both conventional EMG and
microEMG during a single visit. This will allow us to relate the electrical signal patterns
in the muscle measured by MicroEMG to the known diagnostic pattern we typically see in
conventional EMG. We will do this in both healthy and diseased muscles. Based on that we can
determine which of these patterns may be suitable as potential diagnostic markers for the
MicroEMG system.
We will also ask participants about their experience as a patient. It will give us a better
understanding about how patients in our hospital may benefit from the new MicroEMG device in
the future (after further confirmative research).
Who can participate? In this study we want to look at how measurements with the new MicroEMG
look like in patients with neuromuscular diseases - in particular, motor neurone disease,
sarcopenia, post-polio syndrome, and myasthenia gravis. We also want to look at how those
signals compare to signals measured in a healthy control group.
Participants will have a previously known diagnosis of any of the abovementioned diseases.
Not everyone is able to take part. Important reasons why one may not be able to take part
include:
- Having a cardiac pacemaker or implanted defibrillator.
- Alternative neurological disorders.
- Lymphedema or dialysis fistula in the arms or legs.
- Taking clotting inhibitors or having a clotting disorder.
What does the study involve? What will I be asked to do? Initial appointment
- We will ask participants to attend the Neurophysiology Department in Newcastle Hospitals
NHS Trust.
- We will ask participants to fill out a data entry form (e.g. age, gender and contact
details).
- We will ask participants basic questions about their health history to ensure they are
able to take part.
Recording EMG
- We will perform 2 EMG exams, one with a conventional EMG needle that is normally used in
our clinic. Another exam we will use the newly developed MicroEMG.
- We will ask participants to put their phone in flight mode (if possible) and lie on a
couch.
- For each exam we will place a fine needle into in the muscles in the arms and shins (in
total 5 different points). The insertion spots will be cleaned using alcohol beforehand.
- The EMG procedures are uncomfortable and can cause a similar amount of pain to having a
vaccination. They may cause some temporary bruising to the skin but have no long-term
effects.
- Each EMG exam will take approximately 30 minutes.
- At the end of each exam, we will ask participants to fill in a short questionnaire. This
is to learn about their experience of the EMG exam, any discomfort, and any suggestions
for improvement.
- We expect the entire procedure to not take longer than 2 hours.
What are the possible benefits of taking part?
- This study itself will not benefit participants. We expect the results of this study
will help us decide us whether and how MicroEMG may be used as a diagnostic tool in our
hospital in the future.
- We hope that this new system will help with the future diagnosis of diseases which
damage the nerves and muscles. However, to prove this systematically we need to do more
research.
What are the possible risks of taking part?
- The needle test (electromyography) is uncomfortable but has no long-term effects.
- In people with blood clotting abnormalities there is a small risk of bleeding inside the
muscles. To avoid this, anyone with blood clotting problems will be excluded from the
study as a precaution.
- To control risk of infection we clean the skin with alcohol before inserting the sterile
needle. After use, the needle is safely disposed.
- In addition, our department has put in place extensive measures to ensure patient safety
during the Covid-19 pandemic. These have been reviewed and approved by the hospital
Infection Control Team.
Who monitors this study?
• The study is overseen by Newcastle Upon Tyne Hospitals NHS Foundation Trust (NuTH). It is a
requirement that participant records in this research, together with any relevant medical
records, be made available for scrutiny by monitors from NuTH. Their role is to check that
research is properly conducted and the interests of those taking part are adequately
protected. NIHR-BRC has provided funding for this study.
Who can I contact for further information? If you would like further information please
contact Dr Roger Whittaker (0191 28 24578 or 0191 2083543) or Katrin Bangel
(Katrin.Bangel[at]nhs.net)