Ignite Creation Date:
2025-12-25 @ 2:58 AM
Ignite Modification Date:
2025-12-26 @ 1:39 AM
Study NCT ID:
NCT05134233
Status:
COMPLETED
Last Update Posted:
2025-01-23
First Post:
2021-11-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Investigation of Low-intensity Focused Ultrasound Parameters
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jnw@vtc.vt.edu', 'phone': '540-526-2261', 'title': 'Jessica Florig', 'organization': 'Fralin Biomedical Research Institute at VTC'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Beginning (prior to study tasks) and end of each study visit, visits occurring over an average of 4 weeks - participants completed report of symptoms questionnaire.', 'description': 'Collected a Report of Symptoms Questionnaire pre/post LIFU application at each study visit.', 'eventGroups': [{'id': 'EG000', 'title': 'Parameter Trials', 'description': 'Up to 15 parameter combinations will be tested per study session, expected up to 6 sessions of trials. Response recorded using TMS and EMG.\n\nLow-intensity Focused Ultrasound: LIFU application using various parameters, responses of neuromodulation recorded using TMS and EMG.', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 0, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Waveforms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Parameter Trials', 'description': 'Up to 15 parameter combinations will be tested per study session, expected up to 6 sessions of trials. Response recorded using TMS and EMG.\n\nLow-intensity Focused Ultrasound: LIFU application using various parameters, responses of neuromodulation recorded using TMS and EMG.'}], 'classes': [{'title': 'Parameter 1 (6W/cm2-1%DC-100msec)', 'categories': [{'measurements': [{'value': '1.06', 'spread': '0.12', 'groupId': 'OG000'}]}]}, {'title': 'Parameter 2 (6W/cm2-10%DC-100msec)', 'categories': [{'measurements': [{'value': '1.10', 'spread': '0.12', 'groupId': 'OG000'}]}]}, {'title': 'Parameter 3 (6W/cm2-30%DC-100msec)', 'categories': [{'measurements': [{'value': '0.97', 'spread': '.10', 'groupId': 'OG000'}]}]}, {'title': 'Parameter 4 (6W/cm2-50%DC-100msec)', 'categories': [{'measurements': [{'value': '0.99', 'spread': '0.10', 'groupId': 'OG000'}]}]}, {'title': 'Parameter 5 (6W/cm2-70%DC-100msec)', 'categories': [{'measurements': [{'value': '1.03', 'spread': '0.13', 'groupId': 'OG000'}]}]}, {'title': 'Parameter 6 (6W/cm2-1%DC-500msec)', 'categories': [{'measurements': [{'value': '0.80', 'spread': '0.10', 'groupId': 'OG000'}]}]}, {'title': 'Parameter 7 (6W/cm2-10%DC-500msec)', 'categories': [{'measurements': [{'value': '0.84', 'spread': '0.10', 'groupId': 'OG000'}]}]}, {'title': 'Parameter 8 (6W/cm2-30%DC-500msec)', 'categories': [{'measurements': [{'value': '0.70', 'spread': '0.08', 'groupId': 'OG000'}]}]}, {'title': 'Parameter 9 (6W/cm2-50%DC-500msec)', 'categories': [{'measurements': [{'value': '0.81', 'spread': '0.11', 'groupId': 'OG000'}]}]}, {'title': 'Parameter 10 (6W/cm2-70%DC-500msec)', 'categories': [{'measurements': [{'value': '0.75', 'spread': '0.08', 'groupId': 'OG000'}]}]}, {'title': 'Parameter 11 (24W/cm2-1%DC-100msec)', 'categories': [{'measurements': [{'value': '0.86', 'spread': '0.09', 'groupId': 'OG000'}]}]}, {'title': 'Parameter 12 (24W/cm2-10%DC-100msec)', 'categories': [{'measurements': [{'value': '0.93', 'spread': '0.11', 'groupId': 'OG000'}]}]}, {'title': 'Parameter 13 (24W/cm2-30%DC-100msec)', 'categories': [{'measurements': [{'value': '1.01', 'spread': '0.12', 'groupId': 'OG000'}]}]}, {'title': 'Parameter 14 (24W/cm2-50%DC-100msec)', 'categories': [{'measurements': [{'value': '0.91', 'spread': '0.12', 'groupId': 'OG000'}]}]}, {'title': 'Parameter 15 (24W/cm2-70%DC-100msec)', 'categories': [{'measurements': [{'value': '0.91', 'spread': '0.09', 'groupId': 'OG000'}]}]}, {'title': 'Parameter 16 (24W/cm2-1%DC-500msec)', 'categories': [{'measurements': [{'value': '0.75', 'spread': '0.07', 'groupId': 'OG000'}]}]}, {'title': 'Parameter 17 (24W/cm2-10%DC-500msec)', 'categories': [{'measurements': [{'value': '0.79', 'spread': '0.10', 'groupId': 'OG000'}]}]}, {'title': 'Parameter 18 (24W/cm2-30%DC-500msec)', 'categories': [{'measurements': [{'value': '0.84', 'spread': '0.10', 'groupId': 'OG000'}]}]}, {'title': 'Parameter 19 (24W/cm2-50%DC-500msec)', 'categories': [{'measurements': [{'value': '0.93', 'spread': '0.13', 'groupId': 'OG000'}]}]}, {'title': 'Parameter 20 (24W/cm2-70%DC-500msec)', 'categories': [{'measurements': [{'value': '0.84', 'spread': '0.09', 'groupId': 'OG000'}]}]}, {'title': 'Parameter 21 (continuous- 6W/cm2-35000 cycles)', 'categories': [{'measurements': [{'value': '0.84', 'spread': '.11', 'groupId': 'OG000'}]}]}, {'title': 'Parameter 22 (continuous- 24W/cm2-35000 cycles)', 'categories': [{'measurements': [{'value': '1.05', 'spread': '0.13', 'groupId': 'OG000'}]}]}, {'title': 'Parameter 23 (continuous- 6W/cm2-75000 cycles)', 'categories': [{'measurements': [{'value': '1.10', 'spread': '0.13', 'groupId': 'OG000'}]}]}, {'title': 'Parameter 24 (continuous- 24W/cm2-75000 cycles)', 'categories': [{'measurements': [{'value': '0.99', 'spread': '0.10', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Outcome measured throughout study participation - an average of 4 weeks per participant.', 'description': 'Changes in waveform peak will be observed per each variable application of LIFU', 'unitOfMeasure': 'percentage of baseline MEP mV', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant data set had artifacts that could not be removed while leaving usable MEP data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Parameter Trials', 'description': 'Up to 15 parameter combinations will be tested per study session, expected up to 6 sessions of trials. Response recorded using TMS and EMG.\n\nLow-intensity Focused Ultrasound: LIFU application using various parameters, responses of neuromodulation recorded using TMS and EMG.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'MEP value too low', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Parameter Trials', 'description': 'Up to 15 parameter combinations will be tested per study session, expected up to 6 sessions of trials. Response recorded using TMS and EMG.\n\nLow-intensity Focused Ultrasound: LIFU application using various parameters, responses of neuromodulation recorded using TMS and EMG.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000', 'lowerLimit': '20', 'upperLimit': '53'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-09-12', 'size': 757810, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-09-12T14:21', 'hasProtocol': True}, {'date': '2024-09-12', 'size': 185759, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-09-12T14:22', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Multi-visit study, testing various LIFU parameters per session'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-03-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-03', 'studyFirstSubmitDate': '2021-11-10', 'resultsFirstSubmitDate': '2024-09-12', 'studyFirstSubmitQcDate': '2021-11-22', 'lastUpdatePostDateStruct': {'date': '2025-01-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-12-03', 'studyFirstPostDateStruct': {'date': '2021-11-24', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Waveforms', 'timeFrame': 'Outcome measured throughout study participation - an average of 4 weeks per participant.', 'description': 'Changes in waveform peak will be observed per each variable application of LIFU'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['low-intensity focused ultrasound', 'transcranial magnetic stimulation'], 'conditions': ['Development of LIFU for Clinical Purposes']}, 'referencesModule': {'references': [{'pmid': '29968768', 'type': 'BACKGROUND', 'citation': 'Legon W, Bansal P, Tyshynsky R, Ai L, Mueller JK. Transcranial focused ultrasound neuromodulation of the human primary motor cortex. Sci Rep. 2018 Jul 3;8(1):10007. doi: 10.1038/s41598-018-28320-1.'}, {'pmid': '33236981', 'type': 'BACKGROUND', 'citation': 'Fomenko A, Chen KS, Nankoo JF, Saravanamuttu J, Wang Y, El-Baba M, Xia X, Seerala SS, Hynynen K, Lozano AM, Chen R. Systematic examination of low-intensity ultrasound parameters on human motor cortex excitability and behavior. Elife. 2020 Nov 25;9:e54497. doi: 10.7554/eLife.54497.'}, {'pmid': '34487826', 'type': 'BACKGROUND', 'citation': 'Xia X, Fomenko A, Nankoo JF, Zeng K, Wang Y, Zhang J, Lozano AM, Chen R. Time course of the effects of low-intensity transcranial ultrasound on the excitability of ipsilateral and contralateral human primary motor cortex. Neuroimage. 2021 Nov;243:118557. doi: 10.1016/j.neuroimage.2021.118557. Epub 2021 Sep 4.'}]}, 'descriptionModule': {'briefSummary': 'This project examines the effects of different brain stimulation settings on muscle contractions. The investigators believe this study will help to better understand noninvasive brain stimulation techniques that may have the potential to aid in addiction, pain, and mental health issues. Participants undergo structural imaging, an fMRI and CT. These images are used to align the low-intensity focused ultrasound (LIFU) and transcranial magnetic stimulation (TMS) devices to temporarily change brain activity. Electromyography (EMG) will be used to record muscle contractions on the hand.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Above criteria and must understand and speak English.\n\nExclusion Criteria:\n\n* Contraindications to MRI, CT, or TMS\n\n 1. Claustrophobia\n 2. Pacemaker, aneurysm clips, neurostimulators, cochlear implants, metal in eyes, steel worker, or other implants.\n 3. Pregnancy\n 4. Active medical disorder or treatment with potential CNS effects\n 5. History of neurologic disorder\n 6. History of head injury resulting in loss of consciousness for \\>10 minutes\n 7. History of alcohol or drug dependence\n 8. Failure to provide a social security number or tax ID number. This is required for tax purposes or payment cannot be processed.'}, 'identificationModule': {'nctId': 'NCT05134233', 'briefTitle': 'Investigation of Low-intensity Focused Ultrasound Parameters', 'organization': {'class': 'OTHER', 'fullName': 'Virginia Polytechnic Institute and State University'}, 'officialTitle': 'Investigation of Low-intensity Focused Ultrasound Parameters', 'orgStudyIdInfo': {'id': '21-882'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Parameter Trials', 'description': 'Approximately 36 parameter combinations will be tested per study session, expected 6 sessions of trials. Response recorded using TMS and EMG.', 'interventionNames': ['Device: Low-intensity Focused Ultrasound']}], 'interventions': [{'name': 'Low-intensity Focused Ultrasound', 'type': 'DEVICE', 'description': 'LIFU application using various parameters, responses of neuromodulation recorded using TMS and EMG.', 'armGroupLabels': ['Parameter Trials']}]}, 'contactsLocationsModule': {'locations': [{'zip': '24016', 'city': 'Roanoke', 'state': 'Virginia', 'country': 'United States', 'facility': 'Fralin Biomedical Research Institute', 'geoPoint': {'lat': 37.27097, 'lon': -79.94143}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Virginia Polytechnic Institute and State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Wynn Legon', 'investigatorAffiliation': 'Virginia Polytechnic Institute and State University'}}}}