Eye Muscle Needle Electromyogram (EMu) Study
EMu
A Data Collection and Analysis Pilot Study to Indicate Preliminary Characterisation of the Electromyogram Signal in Relation to Needle Position With Respect to the Extraocular Muscles, as Observed During Electromyogram Needle Guided Treatment of Strabismus in Adults
1 other identifier
observational
25
1 country
1
Brief Summary
In some cases, strabismus, or squint, is treated with injections of Botulinum toxin (BTX) to temporarily relax the eye muscle responsible for causing the eye to be pulled to one side. Due to the deep location of the muscles, electromyogram (EMG) needle guidance is used to help ensure the toxin is delivered accurately. EMG needle guidance involves listening to the EMG signal from the tip of the delivery needle - when the needle is in the right place a sound akin to "rain on a tin roof" is heard and the BTX can be injected. From previous research, clearly clinicians want to improve the technology of this procedure and increase the treatment efficacy and repeatability. After all, the current procedure is imprecise and subjective for what is a small target, with the eye muscles being around 2.5 mm to 4.7 mm in diameter. There may also be an increase in the likelihood of side effects such as droopy eyelids when the toxin spreads beyond the target muscle. There is a strong need for new knowledge to improve EMG needle guidance in this context. It is hypothesised that the EMG signal could be cleaned and mined for information in real time during the procedure, thus providing the clinician with better information to guide the positioning of the needle before injecting. This pilot study will deliver the knowledge essential to indicate the feasibility of doing this. If feasible, this study will inform a full study with the aim of benefitting patients by allowing new technology to be developed to improve the treatment of strabismus with BTX.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2019
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 16, 2019
CompletedStudy Start
First participant enrolled
February 20, 2019
CompletedFirst Posted
Study publicly available on registry
March 29, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2019
CompletedResults Posted
Study results publicly available
August 18, 2020
CompletedJuly 18, 2022
January 1, 2019
3 months
January 16, 2019
June 30, 2020
July 1, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
α (Slope) Parameter of the Electromyogram (EMG) Signal Power Spectral Density (PSD) Plot as Needle Approaches Then Enters Muscle.
The continuous change in the EMG signal as the needle is (a) distal to, (b) approaches, and (c) enters, the target extraocular muscle. Welch's periodogram estimator (Hamming window, 256-point FFT, 50% overlap) was applied to each of the three signal segments described above to obtain an estimate of the PSD of the signal. A robust linear model was fit to estimate the α (slope) parameter of each PSD plot.
Approximately 5 minutes, i.e. immediately prior to needle insertion until Botulinum toxin (BTX) delivery and needle withdrawal
Secondary Outcomes (4)
Clinical Score of EMG Change
Approximately 5 minutes, i.e. immediately prior to needle insertion until Botulinum toxin (BTX) delivery and needle withdrawal
Clinical Score of Needle Placement Accuracy
Approximately 5 minutes, i.e. immediately prior to needle insertion until Botulinum toxin (BTX) delivery and needle withdrawal
Clinical Score of EMG Quality.
Approximately 5 minutes, i.e. immediately prior to needle insertion until Botulinum toxin (BTX) delivery and needle withdrawal
Post-treatment Angle of Deviation
2 weeks
Eligibility Criteria
Patients with strabismus being treated with injections of Botulinum toxin.
You may qualify if:
- i. Adults undergoing planned, routine EMG needle guided BTX injection into either lateral or medial rectus muscle for the treatment of strabismus.
- ii. Patients being treated by Mr Yagan.
You may not qualify if:
- \- Patients with Chronic progressive external ophthalmoplegia (CPEO) are excluded; a highly attenuated EMG signal is expected.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Manchester Royal Eye Hospital
Manchester, M13 9WL, United Kingdom
Related Publications (1)
Pinheiro, J. & Bates, D. (2000) Mixed-Effects Models in S and S-PLUS. Statistics and Computing. New York, NY, USA: Springer-Verlag
BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Tristan Payne
- Organization
- Medical Physics & Clinical Engineering, Royal Liverpool Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Tristan G Payne, PhD
Liverpool University Hospitals NHS Foundation Trust
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 16, 2019
First Posted
March 29, 2019
Study Start
February 20, 2019
Primary Completion
May 30, 2019
Study Completion
May 30, 2019
Last Updated
July 18, 2022
Results First Posted
August 18, 2020
Record last verified: 2019-01