Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-01-02 @ 7:00 PM
Study NCT ID:
NCT05730556
Status:
TERMINATED
Last Update Posted:
2025-10-27
First Post:
2023-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Remote Electrical Neuromodulation for Acute Procedural Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-09-29', 'type': 'ESTIMATED'}}}}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Starling.Amaal@mayo.edu', 'phone': '715-537-1345', 'title': 'Amaal Starling, M.D.', 'organization': 'Mayo Clinic'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'This study was terminated early as enough data was collected at interim analysis.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events were collected from the time of informed consent through study completion, approximately 24 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Electrical Neuromodulation', 'description': 'Subjects had the Nerivio ® applied 20 minutes prior to clinical care onabotulinumtoxinA (Botox) injection, and continued to wear the device for a total of 40 to 45 minutes.\n\nNerivio ®: Non-invasive wearable, remote electrical neuromodulation (REN) device controlled by a smartphone application worn on an armband on the upper arm.', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 0, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sham', 'description': 'Subjects had the sham device applied 20 minutes prior to clinical care onabotulinumtoxinA (Botox) injection, and continued to wear the device for a total of 40 to 45 minutes.\n\nSham: Electrical stimulation to mimic study treatment intervention', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 0, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Pain Intensity Measured by Visual Analog Scale (VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Electrical Neuromodulation, Then Sham', 'description': 'Subjects first had the Nerivio ® applied 20 minutes prior to clinical care onabotulinumtoxinA (Botox) injection, and continued to wear the device for a total of 40 to 45 minutes at week 12. Subjects then had the sham device applied 20 minutes prior to clinical care onabotulinumtoxinA (Botox) injection, and continued to wear the device for a total of 40 to 45 minutes at week 24.\n\nNerivio ®: Non-invasive wearable, remote electrical neuromodulation (REN) device controlled by a smartphone application worn on an armband on the upper arm.\n\nSham: Electrical stimulation to mimic study treatment intervention'}, {'id': 'OG001', 'title': 'Sham, Then Electrical Neuromodulation', 'description': 'Subjects first had the sham device applied 20 minutes prior to clinical care onabotulinumtoxinA (Botox) injection, and continued to wear the device for a total of 40 to 45 minutes at week 12. Subjects then had the Nerivio ® applied 20 minutes prior to clinical care onabotulinumtoxinA (Botox) injection, and continued to wear the device for a total of 40 to 45 minutes at week 24.\n\nNerivio ®: Non-invasive wearable, remote electrical neuromodulation (REN) device controlled by a smartphone application worn on an armband on the upper arm.\n\nSham: Electrical stimulation to mimic study treatment intervention'}], 'classes': [{'title': 'Baseline Pre-Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.0', 'spread': '26.3', 'groupId': 'OG000'}, {'value': '32.9', 'spread': '24.8', 'groupId': 'OG001'}]}]}, {'title': 'Baseline Intra-Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '52.5', 'spread': '19.6', 'groupId': 'OG000'}, {'value': '58.3', 'spread': '24.2', 'groupId': 'OG001'}]}]}, {'title': 'Baseline Post-Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '59.9', 'spread': '22.1', 'groupId': 'OG000'}, {'value': '62.0', 'spread': '25.2', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 Pre-Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.2', 'spread': '23.3', 'groupId': 'OG000'}, {'value': '27.0', 'spread': '23.7', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 Intra-Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '37.2', 'spread': '19.3', 'groupId': 'OG000'}, {'value': '60.7', 'spread': '20.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 Post-Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '38.7', 'spread': '19.7', 'groupId': 'OG000'}, {'value': '64.7', 'spread': '21.5', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 Pre-Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.2', 'spread': '24.7', 'groupId': 'OG000'}, {'value': '25.7', 'spread': '20.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 Intra-Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50.4', 'spread': '20.5', 'groupId': 'OG000'}, {'value': '44.5', 'spread': '22.8', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 Post-Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '54.6', 'spread': '23.4', 'groupId': 'OG000'}, {'value': '46.6', 'spread': '25.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12, Week 24', 'description': 'Measured by VAS values reported by participants using the 100-mm Visual Analogue Scale (VAS). The VAS line will be 100 mm long with no intermediate delineations. Each end will be marked with "no pain" on the left, and "worst possible pain" on the right. Participants will identify their pain level by indicating a point on the line between each end. That point will be measured from the "No pain" end, and the number of millimeters will be reported as the pain score. Scores can range from 0 to 100, with higher score indicating worse pain.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Seven (7) participants in the Electrical Neuromodulation, Then Sham arm and Eight (8) participants in Sham, Then Electrical Neuromodulation arm did not have Week 24 data as the trial was stopped early as the stopping rule for efficiency was reached in the interim analysis.'}, {'type': 'SECONDARY', 'title': 'Presence of Post-procedural Headache', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Electrical Neuromodulation, Then Sham', 'description': 'Subjects first had the Nerivio ® applied 20 minutes prior to clinical care onabotulinumtoxinA (Botox) injection, and continued to wear the device for a total of 40 to 45 minutes at week 12. Subjects then had the sham device applied 20 minutes prior to clinical care onabotulinumtoxinA (Botox) injection, and continued to wear the device for a total of 40 to 45 minutes at week 24.\n\nNerivio ®: Non-invasive wearable, remote electrical neuromodulation (REN) device controlled by a smartphone application worn on an armband on the upper arm.\n\nSham: Electrical stimulation to mimic study treatment intervention'}, {'id': 'OG001', 'title': 'Sham, Then Electrical Neuromodulation', 'description': 'Subjects first had the sham device applied 20 minutes prior to clinical care onabotulinumtoxinA (Botox) injection, and continued to wear the device for a total of 40 to 45 minutes at week 12. Subjects then had the Nerivio ® applied 20 minutes prior to clinical care onabotulinumtoxinA (Botox) injection, and continued to wear the device for a total of 40 to 45 minutes at week 24.\n\nNerivio ®: Non-invasive wearable, remote electrical neuromodulation (REN) device controlled by a smartphone application worn on an armband on the upper arm.\n\nSham: Electrical stimulation to mimic study treatment intervention'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Week 12, Week 24', 'description': "Number of subjects to report the presence of post-procedural headache, defined as a headache that lasts for 4 hours or more and is at least moderate in severity or during which abortive medications are used to treat the patient's head pain.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Seven (7) participants in the Electrical Neuromodulation, Then Sham arm and Eight (8) participants in Sham, Then Electrical Neuromodulation arm did not have Week 24 data as the trial was stopped early as the stopping rule for efficiency was reached in the interim analysis.'}, {'type': 'SECONDARY', 'title': 'Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Electrical Neuromodulation', 'description': 'Subjects had the Nerivio ® applied 20 minutes prior to clinical care onabotulinumtoxinA (Botox) injection, and continued to wear the device for a total of 40 to 45 minutes.\n\nNerivio ®: Non-invasive wearable, remote electrical neuromodulation (REN) device controlled by a smartphone application worn on an armband on the upper arm.'}, {'id': 'OG001', 'title': 'Sham, Then Electrical Neuromodulation', 'description': 'Subjects had the sham device applied 20 minutes prior to clinical care onabotulinumtoxinA (Botox) injection, and continued to wear the device for a total of 40 to 45 minutes.\n\nSham: Electrical stimulation to mimic study treatment intervention'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 weeks', 'description': 'Number of adverse events reported', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Electrical Neuromodulation, Then Sham', 'description': 'Subjects first had the Nerivio ® applied 20 minutes prior to clinical care onabotulinumtoxinA (Botox) injection, and continued to wear the device for a total of 40 to 45 minutes at week 12. Subjects then had the sham device applied 20 minutes prior to clinical care onabotulinumtoxinA (Botox) injection, and continued to wear the device for a total of 40 to 45 minutes at week 24.\n\nNerivio ®: Non-invasive wearable, remote electrical neuromodulation (REN) device controlled by a smartphone application worn on an armband on the upper arm.\n\nSham: Electrical stimulation to mimic study treatment intervention'}, {'id': 'FG001', 'title': 'Sham, Then Electrical Neuromodulation', 'description': 'Subjects first had the sham device applied 20 minutes prior to clinical care onabotulinumtoxinA (Botox) injection, and continued to wear the device for a total of 40 to 45 minutes at week 12. Subjects then had the Nerivio ® applied 20 minutes prior to clinical care onabotulinumtoxinA (Botox) injection, and continued to wear the device for a total of 40 to 45 minutes at week 24.\n\nNerivio ®: Non-invasive wearable, remote electrical neuromodulation (REN) device controlled by a smartphone application worn on an armband on the upper arm.\n\nSham: Electrical stimulation to mimic study treatment intervention'}], 'periods': [{'title': 'First Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': '80 participants were consented to the study and of those 80 participants, 20 were withdrawn prior to randomization.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Electrical Neuromodulation, Then Sham', 'description': 'Subjects first had the Nerivio ® applied 20 minutes prior to clinical care onabotulinumtoxinA (Botox) injection, and continued to wear the device for a total of 40 to 45 minutes at week 12. Subjects then had the sham device applied 20 minutes prior to clinical care onabotulinumtoxinA (Botox) injection, and continued to wear the device for a total of 40 to 45 minutes at week 24.\n\nNerivio ®: Non-invasive wearable, remote electrical neuromodulation (REN) device controlled by a smartphone application worn on an armband on the upper arm.\n\nSham: Electrical stimulation to mimic study treatment intervention'}, {'id': 'BG001', 'title': 'Sham, Then Electrical Neuromodulation', 'description': 'Subjects first had the sham device applied 20 minutes prior to clinical care onabotulinumtoxinA (Botox) injection, and continued to wear the device for a total of 40 to 45 minutes at week 12. Subjects then had the Nerivio ® applied 20 minutes prior to clinical care onabotulinumtoxinA (Botox) injection, and continued to wear the device for a total of 40 to 45 minutes at week 24.\n\nNerivio ®: Non-invasive wearable, remote electrical neuromodulation (REN) device controlled by a smartphone application worn on an armband on the upper arm.\n\nSham: Electrical stimulation to mimic study treatment intervention'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '51.5', 'spread': '12.2', 'groupId': 'BG000'}, {'value': '44.5', 'spread': '15.0', 'groupId': 'BG001'}, {'value': '48.0', 'spread': '14.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-11-30', 'size': 656212, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-07-22T17:33', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'whyStopped': 'Enough data was collected to demonstrate device efficacy at interim analysis', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2023-02-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2024-09-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-30', 'studyFirstSubmitDate': '2023-02-06', 'resultsFirstSubmitDate': '2025-09-08', 'studyFirstSubmitQcDate': '2023-02-06', 'lastUpdatePostDateStruct': {'date': '2025-10-27', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-09-30', 'studyFirstPostDateStruct': {'date': '2023-02-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-10-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-09-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Pain Intensity Measured by Visual Analog Scale (VAS)', 'timeFrame': 'Baseline, Week 12, Week 24', 'description': 'Measured by VAS values reported by participants using the 100-mm Visual Analogue Scale (VAS). The VAS line will be 100 mm long with no intermediate delineations. Each end will be marked with "no pain" on the left, and "worst possible pain" on the right. Participants will identify their pain level by indicating a point on the line between each end. That point will be measured from the "No pain" end, and the number of millimeters will be reported as the pain score. Scores can range from 0 to 100, with higher score indicating worse pain.'}], 'secondaryOutcomes': [{'measure': 'Presence of Post-procedural Headache', 'timeFrame': 'Baseline, Week 12, Week 24', 'description': "Number of subjects to report the presence of post-procedural headache, defined as a headache that lasts for 4 hours or more and is at least moderate in severity or during which abortive medications are used to treat the patient's head pain."}, {'measure': 'Adverse Events', 'timeFrame': '24 weeks', 'description': 'Number of adverse events reported'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['OnabotulinumtoxinA (Botox) injections'], 'conditions': ['Chronic Migraine']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the effectiveness of using remote electrical neuromodulation, using the Nerivio ® device, to relieve pain associated with receiving onabotulinumtoxinA (Botox) injections for chronic migraine prevention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Meet the criteria for 1.3 chronic migraine based on ICHD3 criteria.\n* Currently receiving onabotulinumtoxinA per PREEMPT protocol for the treatment of chronic migraine.\n* Patient is willing and able to comply with the protocol to the satisfaction of the investigator.\n* Patient has the capacity to provide written, informed consent for themselves.\n\nExclusion Criteria:\n\n* Participants with an active implanted electrical and/or neurostimulator device (e.g., cardiac pacemaker, cochlear implant).\n* Participants with congestive heart failure (CHF), severe cardiac or cerebrovascular disease.\n* Participants with uncontrolled epilepsy.\n* Pregnant, trying to get pregnant or breastfeeding female participants.\n* Subjects participating in any other interventional clinical study.\n* Participants with other significant pain, medical or psychological problems that in the opinion of the investigator may confound the study assessments.\n* Participants who have previous experience with the device.\n* Patients with cranial deformities, prior cranial surgeries with violation of the calvarium, or shunt placement.\n* Patients receiving concurrent nerve blocks or trigger point injections within the same visit'}, 'identificationModule': {'nctId': 'NCT05730556', 'briefTitle': 'A Study of Remote Electrical Neuromodulation for Acute Procedural Pain', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Remote Electrical Neuromodulation for Acute Procedural Pain in Chronic Migraine Patients Receiving onabotulinumtoxinA', 'orgStudyIdInfo': {'id': '22-011180'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Electrical Neuromodulation, Then Sham', 'description': 'Subjects will first have the Nerivio ® applied 20 minutes prior to clinical care onabotulinumtoxinA (Botox) injection, and continue to wear the device for a total of 40 to 45 minutes at week 12. Subjects will then have the sham device applied 20 minutes prior to clinical care onabotulinumtoxinA (Botox) injection, and continue to wear the device for a total of 40 to 45 minutes at week 24.', 'interventionNames': ['Device: Nerivio ®', 'Device: Sham']}, {'type': 'EXPERIMENTAL', 'label': 'Sham, Then Electrical Neuromodulation', 'description': 'Subjects will first have the sham device applied 20 minutes prior to clinical care onabotulinumtoxinA (Botox) injection, and continue to wear the device for a total of 40 to 45 minutes at week 12. Subjects will then have the Nerivio ® applied 20 minutes prior to clinical care onabotulinumtoxinA (Botox) injection, and continue to wear the device for a total of 40 to 45 minutes at week 24.', 'interventionNames': ['Device: Nerivio ®', 'Device: Sham']}], 'interventions': [{'name': 'Nerivio ®', 'type': 'DEVICE', 'description': 'Non-invasive wearable, remote electrical neuromodulation (REN) device controlled by a smartphone application worn on an armband on the upper arm.', 'armGroupLabels': ['Electrical Neuromodulation, Then Sham', 'Sham, Then Electrical Neuromodulation']}, {'name': 'Sham', 'type': 'DEVICE', 'description': 'Electrical stimulation to mimic study treatment intervention', 'armGroupLabels': ['Electrical Neuromodulation, Then Sham', 'Sham, Then Electrical Neuromodulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic in Arizona', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}], 'overallOfficials': [{'name': 'Amaal Starling, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Amaal J. Starling, M.D.', 'investigatorAffiliation': 'Mayo Clinic'}}}}