Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2026-01-01 @ 9:47 AM
Study NCT ID:
NCT06628193
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-02-17
First Post:
2024-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Low-intensity Focused Ultrasound Effects on Human Memory
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'sham-controlled, repeated measures design conducted across eight sessions'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-11-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2027-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-13', 'studyFirstSubmitDate': '2024-09-23', 'studyFirstSubmitQcDate': '2024-10-02', 'lastUpdatePostDateStruct': {'date': '2025-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Memory Task Accuracy', 'timeFrame': 'up to 6 weeks', 'description': 'The percentage of correct responses during memory recall tasks, measured as a percentage. This metric will evaluate accuracy following LIFU stimulation compared to sham stimulation.'}, {'measure': 'Memory Task Reaction Time', 'timeFrame': 'up to 6 weeks', 'description': 'Reaction time during memory recall tasks, measured in milliseconds. This metric will assess the speed of memory recall following LIFU stimulation compared to sham stimulation.'}], 'secondaryOutcomes': [{'measure': 'Electroencephalography(EEG) Power Spectral Analysis in Targeted Brain Regions', 'timeFrame': 'up to 6 weeks', 'description': 'Change in theta power (4 - 8 HZ) and gamma power (30 - 100 HZ) measured by up to 64-channel EEG systems within targeted brain regions, measured in microvolts squared (uV2). This outcome will assess alterations in brain electrical activities during memory tasks.'}, {'measure': 'Phase-Amplitude Coupling (PAC) Index', 'timeFrame': 'up to 6 weeks', 'description': 'Change in the strength of phase-amplitude coupling between theta and gamma oscillations measured by up to 64-channel electroencephalography (EEG) systems, expressed as a coupling index (unitless ration). This outcome will provide insights into neural connectivity alterations during memory tasks.'}, {'measure': 'Executive Function Score', 'timeFrame': 'up to 6 weeks', 'description': 'Executive function will be assessed using standardized tools form NIH Toolbox Cognitive Battery, with results expressed as T-scores.'}, {'measure': 'Attention Score', 'timeFrame': 'up to 6 weeks', 'description': 'Attention will be measured through the NIH Toolbox Cognitive Battery, with results provided in T-scores'}, {'measure': 'Processing Speed Score', 'timeFrame': 'up to 6 weeks', 'description': 'Processing speed will be evaluated using the NIH Toolbox Cognitive Battery with scores expressed as T-scores.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['LIFU'], 'conditions': ['Memory']}, 'descriptionModule': {'briefSummary': 'This research project is examining the effects of noninvasive brain stimulation on human memory. This study will help to better understand noninvasive brain stimulation techniques that may have the potential to aid in memory dysfunction. Subjects will undergo a magnetic resonance imaging (MRI) and a computed tomography (CT) scan, to take pictures of their brain and skull. They will receive noninvasive brain stimulation using low-intensity focused ultrasound (LIFU) sound waves, to temporarily change brain activity. Their brain signals (MRI or EEG) will be monitored to measure changes in their brain signals. Their heart rate, blood pressure, respiratory rate, eye movement and skin moisture will be monitored as well. They will complete neuropsychological batteries and memory tasks. They will complete questionnaires.', 'detailedDescription': 'This study employs a two-arm, sham-controlled, repeated measures design conducted across eight sessions:\n\nOverall Structure\n\n* Session 1: Baseline Assessment and Imaging\n* Session 2-8: LIFU Stimulation \\*The order of Sessions 2-8 is ideally randomized to control for order effects. The study design allows for flexibility to accommodate varying levels of participant completion while maintaining scientific validity.\n\nDetailed Session Breakdown Session 1: Baseline Assessment and Imaging\n\n* Structural \\& Functional imaging: MRI and CT anatomical scans\n* Administration of questionnaire battery Session 2-8: LIFU Stimulation or Sham\n* Memory task performance\n* Neuropsychological battery administration\n* EEG recording\n* Collection of physiological measures (HR, BP, RR, and EDR)\n\nDesign Considerations: There will be at least one week between Session 1 and Session 2, and at least 48 hours between each subsequent session. This design allows for within-subject comparisons across stimulation conditions, as well as between-subject comparisons if the full protocol is completed. The study protocol is designed to accommodate potential variability in participant availability. While full completion of all sessions is ideal, partial completion can still yield valuable data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects of all ethnicities, who understand and speak English.\n\nExclusion Criteria:\n\n* The exclusion criteria below are regularly implemented in MRI, CT, and EEG experiments for the safety of the subjects and for data quality assurance.\n\n 1. Claustrophobia (scanning environment may be uncomfortable).\n 2. Contraindications to MRI: including pacemaker, aneurysm clips, neurostimulators, cochlear implants, metal in eyes, steel worker, or other implants.\n 3. Contraindications to CT: pregnancy\n 4. Active medical disorder or treatment with potential CNS effects (e.g. Alzheimer\\'s)\n 5. History of neurologic disorder. (e.g. Parkinson\\'s, Epilepsy, or Essential Tremor)\n 6. History of head injury resulting in loss of consciousness for \\>10 minutes.\n 7. History of alcohol or drug dependence (through self-report).'}, 'identificationModule': {'nctId': 'NCT06628193', 'briefTitle': 'Study of Low-intensity Focused Ultrasound Effects on Human Memory', 'organization': {'class': 'OTHER', 'fullName': 'Virginia Polytechnic Institute and State University'}, 'officialTitle': 'Study of Low-intensity Focused Ultrasound Effects on Human Memory', 'orgStudyIdInfo': {'id': '24-999'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Sham LIFU', 'description': 'Sham LIFU stimulation visit with memory tasks and neuropsychological assessments.', 'interventionNames': ['Device: Sham (No Treatment)']}, {'type': 'EXPERIMENTAL', 'label': 'LIFU 1', 'description': 'LIFU stimulation with parameter set 1 visit with memory tasks and neuropsychological assessments.', 'interventionNames': ['Device: Low intensity focused ultrasound']}, {'type': 'EXPERIMENTAL', 'label': 'LIFU 2', 'description': 'LIFU stimulation with parameter set 2 visit with memory tasks and neuropsychological assessments.', 'interventionNames': ['Device: Low intensity focused ultrasound']}, {'type': 'EXPERIMENTAL', 'label': 'LIFU 3', 'description': 'LIFU stimulation with parameter set 3 visit with memory tasks and neuropsychological assessments.', 'interventionNames': ['Device: Low intensity focused ultrasound']}, {'type': 'EXPERIMENTAL', 'label': 'LIFU 4', 'description': 'LIFU stimulation with parameter set 4 visit with memory tasks and neuropsychological assessments.', 'interventionNames': ['Device: Low intensity focused ultrasound']}, {'type': 'EXPERIMENTAL', 'label': 'LIFU 5', 'description': 'LIFU stimulation with parameter set 5 visit with memory tasks and neuropsychological assessments.', 'interventionNames': ['Device: Low intensity focused ultrasound']}, {'type': 'EXPERIMENTAL', 'label': 'LIFU 6', 'description': 'LIFU stimulation with parameter set 6 visit with memory tasks and neuropsychological assessments.', 'interventionNames': ['Device: Low intensity focused ultrasound']}, {'type': 'EXPERIMENTAL', 'label': 'LIFU 7', 'description': 'LIFU stimulation with parameter set 7 visit with memory tasks and neuropsychological assessments.', 'interventionNames': ['Device: Low intensity focused ultrasound']}], 'interventions': [{'name': 'Low intensity focused ultrasound', 'type': 'DEVICE', 'description': 'low-intensity focused ultrasound for neuromodulation applied to the head.', 'armGroupLabels': ['LIFU 1', 'LIFU 2', 'LIFU 3', 'LIFU 4', 'LIFU 5', 'LIFU 6', 'LIFU 7']}, {'name': 'Sham (No Treatment)', 'type': 'DEVICE', 'description': 'Sham LIFU application', 'armGroupLabels': ['Sham LIFU']}]}, 'contactsLocationsModule': {'locations': [{'zip': '24016', 'city': 'Roanoke', 'state': 'Virginia', 'country': 'United States', 'facility': 'Fralin Biomedical Research Institute at VTC', 'geoPoint': {'lat': 37.27097, 'lon': -79.94143}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, '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'}}}}