Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Manchester University NHS Foundation Trust | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Approximately 5 minutes, i.e. immediately prior to needle insertion until Botulinum toxin (BTX) delivery and needle withdrawal |
Not provided
Inclusion Criteria:
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.
Exclusion Criteria:
- Patients with Chronic progressive external ophthalmoplegia (CPEO) are excluded; a highly attenuated EMG signal is expected.
Not provided
Not provided
Not provided
Patients with strabismus being treated with injections of Botulinum toxin.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Tristan G Payne, PhD | Liverpool University Hospitals NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Manchester Royal Eye Hospital | Manchester | M13 9WL | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Pinheiro, J. & Bates, D. (2000) Mixed-Effects Models in S and S-PLUS. Statistics and Computing. New York, NY, USA: Springer-Verlag |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Observation | Patients with strabismus being treated with injections of Botulinum toxin (BTX). BTX dosage varied from 0.5 to 6.0 Units given in a single injection of fluid. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Observation | Participants who were recruited and had their data recorded for this observational study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | 95% Confidence Interval | log (mV^2 / Hz) / log (Hz) | Approximately 5 minutes, i.e. immediately prior to needle insertion until Botulinum toxin (BTX) delivery and needle withdrawal |
|
The duration of the Botulinum toxin injection procedure, typically around 5 minutes for each participant.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Observation | Participants who were recruited and had their data recorded for this observational study. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Tristan Payne | Medical Physics & Clinical Engineering, Royal Liverpool Hospital | 0151 7064225 | tristan.payne@nhs.net |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 21, 2018 | Apr 14, 2020 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D013285 | Strabismus |
| ID | Term |
|---|---|
| D015835 | Ocular Motility Disorders |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. | 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. | 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. | 2 weeks |
| years |
|
| Sex/Gender, Customized | Sex/Gender data were not collected | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Rectus muscle | Whether the target muscle was the medial rectus or lateral rectus | Count of Participants | Participants |
|
| Electrode distance | The measured distance from the participant's outer canthus to the nearest point of the reference electrode | Mean | Full Range | mm |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | 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. | Posted | Mean | Full Range | score on a scale | Approximately 5 minutes, i.e. immediately prior to needle insertion until Botulinum toxin (BTX) delivery and needle withdrawal |
|
|
|
| Secondary | 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. | Posted | Mean | Full Range | percentage of confidence | Approximately 5 minutes, i.e. immediately prior to needle insertion until Botulinum toxin (BTX) delivery and needle withdrawal |
|
|
|
| Secondary | 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. | Posted | Mean | Full Range | score on a scale | Approximately 5 minutes, i.e. immediately prior to needle insertion until Botulinum toxin (BTX) delivery and needle withdrawal |
|
|
|
| Secondary | Post-treatment Angle of Deviation | Change in participant's angle of deviation following treatment, measured in prism dioptres. | Data was not collected; it was determined before recruitment began that the value of this data did not merit the significant inconvenience to participants of returning for follow-up measurements. | Posted | 2 weeks |
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
Not provided
Not provided