StrabismusEMuNCT03895632
Eye Muscle Needle Electromyogram (EMu) Study
An observational study of Strabismus, run by Liverpool University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Strabismus
- How many people
- 25 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Feb 2019to 30 May 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with strabismus being treated with injections of Botulinum toxin.
Who may be able to join
- Adults undergoing planned, routine EMG needle guided BTX injection into either lateral or medial rectus muscle for the treatment of strabismus.
- Patients being treated by Mr Yagan.
Who cannot join
- Patients with Chronic progressive external ophthalmoplegia (CPEO) are excluded; a highly attenuated EMG signal is expected.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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
- Keywords
- Extraocular muscle, Electromyogram, Monopolar, Needle guidance, Botulinum toxin, Strabismus
- Medical subject headings
- Strabismus
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Clinician's score of the step change from baseline EMG to 'active' EMG level heard immediately prior to delivery of Botulinum toxin (BTX) from 1-5. Value from 1 = no significant step change heard, to 5 = a very clear step change heard.
Measured: Approximately 5 minutes, i.e. immediately prior to needle insertion until Botulinum toxin (BTX) delivery and needle withdrawal
Clinical Score of Needle Placement Accuracy
Clinician's score of their confidence in accurate needle placement with respect to the target muscle. Given as a percentage, a higher score indicates more confidence in accurate needle placement.
Measured: Approximately 5 minutes, i.e. immediately prior to needle insertion until Botulinum toxin (BTX) delivery and needle withdrawal
Clinical Score of EMG Quality.
Clinician's score of overall quality of the EMG signal heard during the procedure. A higher score indicates better quality of EMG signal, and is quantified as 1 to 5, where: 1 indicates signal not present and 5 indicates excellent quality EMG signal.
Measured: Approximately 5 minutes, i.e. immediately prior to needle insertion until Botulinum toxin (BTX) delivery and needle withdrawal
Post-treatment Angle of Deviation
Change in participant's angle of deviation following treatment, measured in prism dioptres.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2019
- Study start20 Feb 2019
- Primary completion30 May 2019
- Study completion30 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrabismusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liverpool University Hospitals NHS Foundation Trust
- Sponsor type
- Other government
- Collaborators
- Manchester University NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Tristan G Payne, PhD, Principal investigator, Liverpool University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03895632
- Sponsor's protocol ID
- 5686
- Acronym
- EMu
- Status last verified
- Jan 2019
- First submitted
- 16 Jan 2019
- Last updated
- 18 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pinheiro, J. & Bates, D. (2000) Mixed-Effects Models in S and S-PLUS. Statistics and Computing. New York, NY, USA: Springer-Verlag
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03895632
- Acronym / sponsor ID
- EMu / 5686
- Conditions
- Strabismus
- Keywords
- Extraocular muscle, Electromyogram, Monopolar, Needle guidance, Botulinum toxin, Strabismus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Liverpool University Hospitals NHS Foundation TrustOther government
- Collaborators
- Manchester University NHS Foundation Trust
- Study start
- 20 Feb 2019 (actual)
- Primary completion
- 30 May 2019 (actual)
- Study completion
- 30 May 2019 (actual)
- First posted
- 29 Mar 2019 (actual)
- Results
- Posted 18 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with strabismus being treated with injections of Botulinum toxin.
Key inclusion criteria (2 listed)
- Adults undergoing planned, routine EMG needle guided BTX injection into either lateral or medial rectus muscle for the treatment of strabismus.
- Patients being treated by Mr Yagan.
Key exclusion criteria (1 listed)
- Patients with Chronic progressive external ophthalmoplegia (CPEO) are excluded; a highly attenuated EMG signal is expected.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
α (Slope) Parameter of the Electromyogram (EMG) Signal Power Spectral Density (PSD) Plot as Needle Approaches Then Enters Muscle.
Time frame: Approximately 5 minutes, i.e. immediately prior to needle insertion until Botulinum toxin (BTX) delivery and needle withdrawal
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.
4 secondary outcomes
Clinical Score of EMG Change
Time frame: Approximately 5 minutes, i.e. immediately prior to needle insertion until Botulinum toxin (BTX) delivery and needle withdrawal
Clinical Score of Needle Placement Accuracy
Time frame: Approximately 5 minutes, i.e. immediately prior to needle insertion until Botulinum toxin (BTX) delivery and needle withdrawal
Clinical Score of EMG Quality.
Time frame: Approximately 5 minutes, i.e. immediately prior to needle insertion until Botulinum toxin (BTX) delivery and needle withdrawal
Post-treatment Angle of Deviation
Time frame: 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundPinheiro, J. & Bates, D. (2000) Mixed-Effects Models in S and S-PLUS. Statistics and Computing. New York, NY, USA: Springer-Verlag
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tristan G Payne, PhD principal investigator
Liverpool University Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Strabismus, run by Liverpool University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
α (Slope) Parameter of the Electromyogram (EMG) Signal Power Spectral Density (PSD) Plot as Needle Approaches Then Enters Muscle. (time frame: Approximately 5 minutes, i.e. immediately prior to needle insertion until Botulinum toxin (BTX) delivery and needle withdrawal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03895632, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2022.