Ignite Creation Date:
2025-12-24 @ 9:47 PM
Ignite Modification Date:
2026-01-02 @ 10:17 AM
Study NCT ID:
NCT03895632
Status:
COMPLETED
Last Update Posted:
2022-07-18
First Post:
2019-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Eye Muscle Needle Electromyogram (EMu) Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013285', 'term': 'Strabismus'}], 'ancestors': [{'id': 'D015835', 'term': 'Ocular Motility Disorders'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tristan.payne@nhs.net', 'phone': '0151 7064225', 'title': 'Dr. Tristan Payne', 'organization': 'Medical Physics & Clinical Engineering, Royal Liverpool Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'The duration of the Botulinum toxin injection procedure, typically around 5 minutes for each participant.', 'eventGroups': [{'id': 'EG000', 'title': 'Observation', 'description': 'Participants who were recruited and had their data recorded for this observational study.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'α (Slope) Parameter of the Electromyogram (EMG) Signal Power Spectral Density (PSD) Plot as Needle Approaches Then Enters Muscle.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Observation', 'description': 'Participants who were recruited and had their data recorded for this observational study.'}], 'classes': [{'title': 'Off-target', 'categories': [{'measurements': [{'value': '1.49', 'groupId': 'OG000', 'lowerLimit': '1.22', 'upperLimit': '1.76'}]}]}, {'title': 'Approaching-target', 'categories': [{'measurements': [{'value': '2.86', 'groupId': 'OG000', 'lowerLimit': '2.59', 'upperLimit': '3.13'}]}]}, {'title': 'On-target', 'categories': [{'measurements': [{'value': '3.56', 'groupId': 'OG000', 'lowerLimit': '3.29', 'upperLimit': '3.83'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'pValueComment': 'p-value obtained form the Wald statistics of the linear mixed-effects model. The threshold for statistical signifiance was p=0.01.', 'groupDescription': 'The null hypothesis was that α (the slope of the Power Spectral Density (PSD) plot) is not related to signal segment (off-, approaching- and on-target).', 'statisticalMethod': 'Linear mixed-effects model', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'A linear mixed-effects model was fit to assess the association between α (the slope of the Power Spectral Density (PSD) plot) and signal segment.'}], 'paramType': 'NUMBER', 'timeFrame': 'Approximately 5 minutes, i.e. immediately prior to needle insertion until Botulinum toxin (BTX) delivery and needle withdrawal', 'description': "The continuous change in the EMG signal as the needle is (a) distal to, (b) approaches, and (c) enters, the target extraocular muscle.\n\nWelch'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.", 'unitOfMeasure': 'log (mV^2 / Hz) / log (Hz)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Clinical Score of EMG Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Observation', 'description': 'Participants who were recruited and had their data recorded for this observational study.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.6', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '5'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Approximately 5 minutes, i.e. immediately prior to needle insertion until Botulinum toxin (BTX) delivery and needle withdrawal', 'description': "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.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Clinical Score of Needle Placement Accuracy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Observation', 'description': 'Participants who were recruited and had their data recorded for this observational study.'}], 'classes': [{'categories': [{'measurements': [{'value': '87.6', 'groupId': 'OG000', 'lowerLimit': '50', 'upperLimit': '95'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Approximately 5 minutes, i.e. immediately prior to needle insertion until Botulinum toxin (BTX) delivery and needle withdrawal', 'description': "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.", 'unitOfMeasure': 'percentage of confidence', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Clinical Score of EMG Quality.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Observation', 'description': 'Participants who were recruited and had their data recorded for this observational study.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '5'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Approximately 5 minutes, i.e. immediately prior to needle insertion until Botulinum toxin (BTX) delivery and needle withdrawal', 'description': "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.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Post-treatment Angle of Deviation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Observation', 'description': 'Participants who were recruited and had their data recorded for this observational study.'}], 'timeFrame': '2 weeks', 'description': "Change in participant's angle of deviation following treatment, measured in prism dioptres.", 'reportingStatus': 'POSTED', 'populationDescription': '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.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Observation', 'description': 'Patients with strabismus being treated with injections of Botulinum toxin (BTX).\n\nBTX dosage varied from 0.5 to 6.0 Units given in a single injection of fluid.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Observation', 'description': 'Participants who were recruited and had their data recorded for this observational study.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '75'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Not recorded', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Sex/Gender data were not collected'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Rectus muscle', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Medial rectus', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Lateral rectus', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Whether the target muscle was the medial rectus or lateral rectus', 'unitOfMeasure': 'Participants'}, {'title': 'Electrode distance', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000', 'lowerLimit': '10', 'upperLimit': '17'}]}]}], 'paramType': 'MEAN', 'description': "The measured distance from the participant's outer canthus to the nearest point of the reference electrode", 'unitOfMeasure': 'mm', 'dispersionType': 'FULL_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-11-21', 'size': 618297, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-04-14T12:40', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2019-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-01', 'studyFirstSubmitDate': '2019-01-16', 'resultsFirstSubmitDate': '2020-06-30', 'studyFirstSubmitQcDate': '2019-03-27', 'lastUpdatePostDateStruct': {'date': '2022-07-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-04', 'studyFirstPostDateStruct': {'date': '2019-03-29', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-08-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'α (Slope) Parameter of the Electromyogram (EMG) Signal Power Spectral Density (PSD) Plot as Needle Approaches Then Enters Muscle.', 'timeFrame': 'Approximately 5 minutes, i.e. immediately prior to needle insertion until Botulinum toxin (BTX) delivery and needle withdrawal', 'description': "The continuous change in the EMG signal as the needle is (a) distal to, (b) approaches, and (c) enters, the target extraocular muscle.\n\nWelch'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."}], 'secondaryOutcomes': [{'measure': 'Clinical Score of EMG Change', 'timeFrame': 'Approximately 5 minutes, i.e. immediately prior to needle insertion until Botulinum toxin (BTX) delivery and needle withdrawal', 'description': "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."}, {'measure': 'Clinical Score of Needle Placement Accuracy', 'timeFrame': 'Approximately 5 minutes, i.e. immediately prior to needle insertion until Botulinum toxin (BTX) delivery and needle withdrawal', 'description': "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."}, {'measure': 'Clinical Score of EMG Quality.', 'timeFrame': 'Approximately 5 minutes, i.e. immediately prior to needle insertion until Botulinum toxin (BTX) delivery and needle withdrawal', 'description': "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."}, {'measure': 'Post-treatment Angle of Deviation', 'timeFrame': '2 weeks', 'description': "Change in participant's angle of deviation following treatment, measured in prism dioptres."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Extraocular muscle', 'Electromyogram', 'Monopolar', 'Needle guidance', 'Botulinum toxin', 'Strabismus'], 'conditions': ['Strabismus']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Pinheiro, J. & Bates, D. (2000) Mixed-Effects Models in S and S-PLUS. Statistics and Computing. New York, NY, USA: Springer-Verlag'}]}, 'descriptionModule': {'briefSummary': '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.\n\nFrom 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.\n\nThere 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with strabismus being treated with injections of Botulinum toxin.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\ni. Adults undergoing planned, routine EMG needle guided BTX injection into either lateral or medial rectus muscle for the treatment of strabismus.\n\nii. Patients being treated by Mr Yagan.\n\nExclusion Criteria:\n\n\\- Patients with Chronic progressive external ophthalmoplegia (CPEO) are excluded; a highly attenuated EMG signal is expected.'}, 'identificationModule': {'nctId': 'NCT03895632', 'acronym': 'EMu', 'briefTitle': 'Eye Muscle Needle Electromyogram (EMu) Study', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Liverpool University Hospitals NHS Foundation Trust'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '5686'}}, 'contactsLocationsModule': {'locations': [{'zip': 'M13 9WL', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Manchester Royal Eye Hospital', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'overallOfficials': [{'name': 'Tristan G Payne, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Liverpool University Hospitals NHS Foundation Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Liverpool University Hospitals NHS Foundation Trust', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Manchester University NHS Foundation Trust', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}