Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-26 @ 2:21 AM
Study NCT ID:
NCT05896202
Status:
COMPLETED
Last Update Posted:
2025-10-27
First Post:
2023-05-31
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Addressing Disparities in Neuromodulation for Rehabilitation: A Mixed Methods Approach to Optimize Access for Underrepresented Racial Minorities
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009437', 'term': 'Neuralgia'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mwong2@miami.edu', 'phone': '3052842670', 'title': 'Marlon L. Wong', 'organization': 'University of Miami'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '3 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) Group', 'description': 'This group will receive supplemental videos on taVNS and TMS. Participants will be in this group for approximately 7 hours.\n\ntaVNS Video: One third of the participants will see the taVNS video once in person. The video will be 2-3 minutes in length and contain information on the procedures of the technique and what participants should expect to feel/experience.\n\nEducational materials: Participants will receive sample consent forms and brochures for taVNS and TMS. These materials will be reviewed with each participant once on site, and they will have the opportunity to ask questions. participants will take these materials home and have the opportunity to review further at their leisure.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Transcranial Magnetic Stimulation (TMS) Group', 'description': 'This group will receive a supplemental video on TMS only. Participants will be in this group for approximately 7 hours.\n\nEducational materials: Participants will receive sample consent forms and brochures for taVNS and TMS. These materials will be reviewed with each participant once on site, and they will have the opportunity to ask questions. participants will take these materials home and have the opportunity to review further at their leisure.\n\nTMS Video: One third of the participants will see the TMS video once in person. The video will be 2-3 minutes in length and contain information on the procedures of the technique and what participants should expect to feel/experience.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change Expectation for Pain Relief as Measured by EXPECT Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) Group', 'description': 'This group will receive supplemental videos on taVNS and TMS. Participants will be in this group for approximately 7 hours.\n\ntaVNS Video: One third of the participants will see the taVNS video once in person. The video will be 2-3 minutes in length and contain information on the procedures of the technique and what participants should expect to feel/experience.\n\nEducational materials: Participants will receive sample consent forms and brochures for taVNS and TMS. These materials will be reviewed with each participant once on site, and they will have the opportunity to ask questions. participants will take these materials home and have the opportunity to review further at their leisure.'}, {'id': 'OG001', 'title': 'Transcranial Magnetic Stimulation (TMS) Group', 'description': 'This group will receive a supplemental video on TMS only. Participants will be in this group for approximately 7 hours.\n\nEducational materials: Participants will receive sample consent forms and brochures for taVNS and TMS. These materials will be reviewed with each participant once on site, and they will have the opportunity to ask questions. participants will take these materials home and have the opportunity to review further at their leisure.\n\nTMS Video: One third of the participants will see the TMS video once in person. The video will be 2-3 minutes in length and contain information on the procedures of the technique and what participants should expect to feel/experience.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.19', 'spread': '1.16', 'groupId': 'OG000'}, {'value': '0.28', 'spread': '1.08', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, and up to 90 minutes', 'description': 'The Expectations for Complementary and Alternative Medicine Treatments (EXPECT) is a 4-item questionnaire that assesses expectations for pain improvement. Each of the 4 items is scored on an 11-point scale, with 0 being no change and 10 representing complete relief (scores ranging from 0-10). Higher scores represent greater expectations for pain relief. Scores from all 4 items are summed to produce a total score ranging from 0 to 40, with higher scores indicating greater expectations for pain relief.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Heart Rate Variability (HRV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active taVNS', 'description': 'Active stimulation applied to the cymba concha for 60 minutes'}, {'id': 'OG001', 'title': 'Sham Stimulation', 'description': 'Active stimulation applied to the ear lobe for 60 minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '0.42', 'spread': '9.73', 'groupId': 'OG000'}, {'value': '-0.37', 'spread': '12.89', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, up to 90 minutes', 'description': 'HRV will be measured with an H10 chest strap device measured in milliseconds (SDRR).', 'unitOfMeasure': 'Milliseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) Group', 'description': 'This group will receive supplemental videos on taVNS and TMS. Participants will be in this group for approximately 7 hours.\n\ntaVNS Video: One third of the participants will see the taVNS video once in person. The video will be 2-3 minutes in length and contain information on the procedures of the technique and what participants should expect to feel/experience.\n\nEducational materials: Participants will receive sample consent forms and brochures for taVNS and TMS. These materials will be reviewed with each participant once on site, and they will have the opportunity to ask questions. participants will take these materials home and have the opportunity to review further at their leisure.'}, {'id': 'FG001', 'title': 'Transcranial Magnetic Stimulation (TMS) Group', 'description': 'This group will receive a supplemental video on TMS only. Participants will be in this group for approximately 7 hours.\n\nEducational materials: Participants will receive sample consent forms and brochures for taVNS and TMS. These materials will be reviewed with each participant once on site, and they will have the opportunity to ask questions. participants will take these materials home and have the opportunity to review further at their leisure.\n\nTMS Video: One third of the participants will see the TMS video once in person. The video will be 2-3 minutes in length and contain information on the procedures of the technique and what participants should expect to feel/experience.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) Group', 'description': 'This group will receive supplemental videos on taVNS and TMS. Participants will be in this group for approximately 7 hours.\n\ntaVNS Video: One third of the participants will see the taVNS video once in person. The video will be 2-3 minutes in length and contain information on the procedures of the technique and what participants should expect to feel/experience.\n\nEducational materials: Participants will receive sample consent forms and brochures for taVNS and TMS. These materials will be reviewed with each participant once on site, and they will have the opportunity to ask questions. participants will take these materials home and have the opportunity to review further at their leisure.'}, {'id': 'BG001', 'title': 'Transcranial Magnetic Stimulation (TMS) Group', 'description': 'This group will receive a supplemental video on TMS only. Participants will be in this group for approximately 7 hours.\n\nEducational materials: Participants will receive sample consent forms and brochures for taVNS and TMS. These materials will be reviewed with each participant once on site, and they will have the opportunity to ask questions. participants will take these materials home and have the opportunity to review further at their leisure.\n\nTMS Video: One third of the participants will see the TMS video once in person. The video will be 2-3 minutes in length and contain information on the procedures of the technique and what participants should expect to feel/experience.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.2', 'spread': '11.3', 'groupId': 'BG000'}, {'value': '59.0', 'spread': '7.5', 'groupId': 'BG001'}, {'value': '58.6', 'spread': '9.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-12-16', 'size': 353111, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-10-13T17:34', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2024-07-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-13', 'studyFirstSubmitDate': '2023-05-31', 'resultsFirstSubmitDate': '2025-09-19', 'studyFirstSubmitQcDate': '2023-05-31', 'lastUpdatePostDateStruct': {'date': '2025-10-27', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-10-13', 'studyFirstPostDateStruct': {'date': '2023-06-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-10-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-07-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change Expectation for Pain Relief as Measured by EXPECT Scores', 'timeFrame': 'Baseline, and up to 90 minutes', 'description': 'The Expectations for Complementary and Alternative Medicine Treatments (EXPECT) is a 4-item questionnaire that assesses expectations for pain improvement. Each of the 4 items is scored on an 11-point scale, with 0 being no change and 10 representing complete relief (scores ranging from 0-10). Higher scores represent greater expectations for pain relief. Scores from all 4 items are summed to produce a total score ranging from 0 to 40, with higher scores indicating greater expectations for pain relief.'}], 'secondaryOutcomes': [{'measure': 'Change in Heart Rate Variability (HRV)', 'timeFrame': 'Baseline, up to 90 minutes', 'description': 'HRV will be measured with an H10 chest strap device measured in milliseconds (SDRR).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['neurostimulation', 'video enhanced consent', 'neuromodulation', 'transcutaneous auricular vagus nerve stimulation', 'transcranial direct current stimulation', 'transcranial magnetic stimulation'], 'conditions': ['Neuropathic Pain']}, 'referencesModule': {'references': [{'pmid': '39896735', 'type': 'DERIVED', 'citation': 'Wong ML, Widerstrom-Noga E, Bolanos JL, Gonzalez G, Penedo FJ, Hosein PJ, Tovin MM, Gonzalez JP, McTeague LM. Feasibility of trancutaneous auricular vagus nerve stimulation in Black and Hispanic/Latino people with peripheral neuropathy. Front Pain Res (Lausanne). 2025 Jan 17;5:1516196. doi: 10.3389/fpain.2024.1516196. eCollection 2024.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to:\n\n1. Development of culturally sensitive videos for enhance informed consent with neurostimulation and determination of factors that influence minority interest in participating in neurostimulation research.\n2. Examination of the influence that video enhanced informed consent has on expectations with transcutaneous auricular vagus nerve stimulation (taVNS) and on treatment intended effects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. between the ages of 18-80 years\n2. neuropathic pain lasting longer than 3 months (i.e., complaint of sensation of burning, stabbing or pressing pain, shooting or shock like pain, or paresthesias)\n3. Neuropathic Pain Symptom Inventory score ≥10.\n4. self identifies as Black or Hispanic\n\nExclusion Criteria:\n\n1. any unstable medical condition or medical contraindication to moderate physical exertion (e.g., unstable angina or cardiac arrythmia)\n2. pregnancy\n3. currently taking Buprenorphine or recently stopped taking (within 1 month)\n4. presence of cognitive impairment or language barrier that impairs full autonomy in the consent process or in the ability to participate in detailed interviews\n5. implants in the head or neck, cochlear implants, or pacemaker\n6. head or neck metastasis or recent ear trauma\n7. history of seizures.'}, 'identificationModule': {'nctId': 'NCT05896202', 'briefTitle': 'Addressing Disparities in Neuromodulation for Rehabilitation: A Mixed Methods Approach to Optimize Access for Underrepresented Racial Minorities', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Addressing Disparities in Neuromodulation for Rehabilitation: A Mixed Methods Approach to Optimize Access for Underrepresented Racial Minorities', 'orgStudyIdInfo': {'id': '20230154'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Transcutaneous Auricular Vagus Nerve stimulation (taVNS) group', 'description': 'This group will receive supplemental videos on taVNS and TMS. Participants will be in this group for approximately 7 hours.', 'interventionNames': ['Other: taVNS Video', 'Other: Educational materials']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Transcranial Magnetic Stimulation (TMS) group', 'description': 'This group will receive a supplemental video on TMS only. Participants will be in this group for approximately 7 hours.', 'interventionNames': ['Other: Educational materials', 'Other: TMS Video']}], 'interventions': [{'name': 'taVNS Video', 'type': 'OTHER', 'description': 'One third of the participants will see the taVNS video once in person. The video will be 2-3 minutes in length and contain information on the procedures of the technique and what participants should expect to feel/experience.', 'armGroupLabels': ['Transcutaneous Auricular Vagus Nerve stimulation (taVNS) group']}, {'name': 'Educational materials', 'type': 'OTHER', 'description': 'Participants will receive sample consent forms and brochures for taVNS and TMS. These materials will be reviewed with each participant once on site, and they will have the opportunity to ask questions. participants will take these materials home and have the opportunity to review further at their leisure.', 'armGroupLabels': ['Transcranial Magnetic Stimulation (TMS) group', 'Transcutaneous Auricular Vagus Nerve stimulation (taVNS) group']}, {'name': 'TMS Video', 'type': 'OTHER', 'description': 'One third of the participants will see the TMS video once in person. The video will be 2-3 minutes in length and contain information on the procedures of the technique and what participants should expect to feel/experience.', 'armGroupLabels': ['Transcranial Magnetic Stimulation (TMS) group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33176', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Marlon Wong', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center of Neuromodulation for Rehabilitation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Clinical Physical Therapy', 'investigatorFullName': 'Marlon Wong', 'investigatorAffiliation': 'University of Miami'}}}}