Ignite Creation Date:
2025-12-24 @ 7:25 PM
Ignite Modification Date:
2026-01-01 @ 8:40 PM
Study NCT ID:
NCT05147103
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-07-04
First Post:
2021-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of the Duration of Low-intensity Focused Ultrasound
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, '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 durations'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2022-08-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-01', 'studyFirstSubmitDate': '2021-11-10', 'studyFirstSubmitQcDate': '2021-12-06', 'lastUpdatePostDateStruct': {'date': '2025-07-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Waveforms', 'timeFrame': 'Outcomes assessed throughout participation - an average of 3 weeks.', 'description': 'Changes in waveform peak will be observed per each variable application of LIFU'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, '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': '29380485', 'type': 'BACKGROUND', 'citation': 'Legon W, Ai L, Bansal P, Mueller JK. Neuromodulation with single-element transcranial focused ultrasound in human thalamus. Hum Brain Mapp. 2018 May;39(5):1995-2006. doi: 10.1002/hbm.23981. Epub 2018 Jan 29.'}, {'pmid': '24413698', 'type': 'BACKGROUND', 'citation': 'Legon W, Sato TF, Opitz A, Mueller J, Barbour A, Williams A, Tyler WJ. Transcranial focused ultrasound modulates the activity of primary somatosensory cortex in humans. Nat Neurosci. 2014 Feb;17(2):322-9. doi: 10.1038/nn.3620. Epub 2014 Jan 12.'}]}, 'descriptionModule': {'briefSummary': 'This project examines the effects of various durations of noninvasive neuromodulation 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, a functional Magnetic Resonance Image (fMRI) and computed tomography (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 of 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'}, 'identificationModule': {'nctId': 'NCT05147103', 'briefTitle': 'Investigation of the Duration of Low-intensity Focused Ultrasound', 'organization': {'class': 'OTHER', 'fullName': 'Virginia Polytechnic Institute and State University'}, 'officialTitle': 'Investigation of the Duration of Low-intensity Focused Ultrasound', 'orgStudyIdInfo': {'id': '21-892'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Duration Trials', 'description': 'Six different durations (three intermittent and three continuous) of LIFU application will be tested across six study sessions. 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 durations, responses of neuromodulation recorded using TMS and EMG.', 'armGroupLabels': ['Duration 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'}}}}