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Eye Muscle Needle Electromyogram (EMu) Study

NCT03895632 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 25

Last updated 2022-07-18

Study results available
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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.

Conditions

  • Strabismus

Sponsors & Collaborators

  • Manchester University NHS Foundation Trust

    collaborator OTHER_GOV

  • Liverpool University Hospitals NHS Foundation Trust

    lead OTHER_GOV

Principal Investigators

  • Tristan G Payne, PhD · Liverpool University Hospitals NHS Foundation Trust

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-20
Primary Completion
2019-05-30
Completion
2019-05-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03895632 on ClinicalTrials.gov