Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-25 @ 7:10 PM
Study NCT ID:
NCT05194332
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-11
First Post:
2022-01-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Transcranial Low Intensity Focused Ultrasound Neuromodulation as a Probe to Study Human Emotion and Cognitive Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D001523', 'term': 'Mental Disorders'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2028-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-05', 'studyFirstSubmitDate': '2022-01-03', 'studyFirstSubmitQcDate': '2022-01-03', 'lastUpdatePostDateStruct': {'date': '2024-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in amygdala activity indicated by functional magnetic resonance imaging (fMRI) scan blood oxygen-level-dependent (BOLD) signal', 'timeFrame': 'baseline, 5 mins post-LIFUP sonication'}, {'measure': 'Changes in brain resting state functional network as indicated by fMRI scan connectivity measures', 'timeFrame': 'baseline, 10-20 mins post-LIFUP sonication'}], 'secondaryOutcomes': [{'measure': 'Change in performance on Reward Task', 'timeFrame': 'baseline, 1-hour post-LIFUP sonication'}, {'measure': 'Tolerability of LIFUP sonication as assessed number of adverse events', 'timeFrame': 'baseline, immediately after LIFUP sonication'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['depression', 'mental illness'], 'conditions': ['Depressive Disorder, Major']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the low-intensity focused ultrasound pulsation (LIFUP) neuromodulation on emotion processing in healthy individuals, and to assess the overall safety of the LIFUP to stimulate or inhibit brain activity in healthy volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must be right-handed\n* Must be illicit drug-free at the time of scanning as appropriate (verified by negative urine drug screen)\n* Must be healthy (without medical, neurological, psychiatric illness)\n* Must be psychotropic medication free (≥ 14 days)\n\nExclusion Criteria:\n\n* Must not be a smoker\n* Females must not be pregnant or nursing\n* Must not suffer from claustrophobia\n* Must not meet exclusion criteria for MRI scanning (i.e., non-fixed magnetizable objects)\n* Must not have ongoing, chronic, or relapsing/remitting medical, psychiatric,or neurological illness as determined by a combination of history, medical record, and/or examination.'}, 'identificationModule': {'nctId': 'NCT05194332', 'briefTitle': 'Transcranial Low Intensity Focused Ultrasound Neuromodulation as a Probe to Study Human Emotion and Cognitive Function', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'Transcranial Low Intensity Focused Ultrasound Neuromodulation as a Probe to Study Human Emotion and Cognitive Function', 'orgStudyIdInfo': {'id': 'HSC-MS-21-0570'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LIFUP sonication to the amygdala', 'interventionNames': ['Device: LIFUP sonication to the amygdala']}], 'interventions': [{'name': 'LIFUP sonication to the amygdala', 'type': 'DEVICE', 'description': 'LIFUP sonication to amygdala will be performed.', 'armGroupLabels': ['LIFUP sonication to the amygdala']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'contacts': [{'name': 'Andrea Boscutti, MD', 'role': 'CONTACT', 'email': 'Andrea.Boscutti@uth.tmc.edu', 'phone': '713-486-2622'}, {'name': 'Juliana Figueiredo', 'role': 'CONTACT'}], 'facility': 'The University of Texas Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Andrea Boscutti, MD', 'role': 'CONTACT', 'email': 'Andrea.Boscutti@uth.tmc.edu', 'phone': '713-486-2622'}], 'overallOfficials': [{'name': 'Jair Soares, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jair Soares', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}