CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 25 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT03895632
NCT03895632N/ACompleted

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

Liverpool University Hospitals NHS Foundation Trust·observational·Posted Mar 29, 2019·Updated Jul 18, 2022

In Brief

An observational study for Strabismus. Completed, enrolled 25 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsStrabismus
CountriesUnited Kingdom

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedMar 29, 2019
Enrollment StartFeb 20, 2019
Primary CompletionMay 30, 2019
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 7.3 years ago