Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2025-12-26 @ 2:13 AM
Study NCT ID:
NCT07220005
Status:
RECRUITING
Last Update Posted:
2025-12-23
First Post:
2025-10-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Low Intensity Focused Ultrasound Stimulation in Stroke Patients - Parameter Optimization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D010291', 'term': 'Paresis'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-19', 'studyFirstSubmitDate': '2025-10-21', 'studyFirstSubmitQcDate': '2025-10-21', 'lastUpdatePostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Motor sequence learning', 'timeFrame': 'Baseline, immediately after intervention, and 1 hour after intervention', 'description': 'Motor sequence learning (MSL) involves predictive processing that results in the anticipation of each component of a sequence of actions. MSL will produce response times and the MSL measure will be the number of responders (i.e., those with ≥20% reduction in the response time).'}, {'measure': 'Corticospinal excitability', 'timeFrame': 'Baseline, immediately after intervention, and 1 hour after intervention.', 'description': 'Corticospinal excitability is measured by the peak to peak amplitude of motor evoked potential.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Brain Stimulation', 'Transcranial Focused Ultrasound Stimulation', 'Low Intensity Focused Ultrasound Stimulation', 'Stroke Recovery', 'Motor Learning', 'Corticospinal Excitability'], 'conditions': ['Stroke', 'Arm Weakness as a Consequence of Stroke', 'Upper Extremity Hemiparesis', 'Upper Extremity Impairments', 'Upper Extremity Weakness']}, 'descriptionModule': {'briefSummary': 'The goal of this research study is to optimize the parameter of Low-Intensity Focused Ultrasound Stimulation (LIFUS) that is most effective in changing cortical excitability and motor learning skills in patients who suffered a stroke. The researchers hope to answer two questions.\n\n* with increasing power, would LIFUS be more effective?\n* with the same power, what LIFUS timing is the best\n\nFor Aim 1, the study will compare 8, 4 W/cm\\^2 to a zero(sham) stimulation to see if higher power is the better.\n\nFor Aim 2, the study will compare 500 vs 1000 vs 2000 Hz "timing" to see which one is better.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* age \\>=21 years old of any gender or race\n* First-ever ischemic or hemorrhagic stroke (neuroimaging verified) at least 6 months from the stroke onset of symptoms\n* Unilateral arm weakness measured by the Fugl-Meyer Upper-Extremity Scale ≤ 62/64\n* Inducible rest motor threshold and testing motor threshold recorded from the affected abductor pollicis brevis muscle\n\nExclusion Criteria:\n\n* Bilateral strokes (infarcts and/or hematoma)\n* Other co-existent neuromuscular disorders affecting upper extremity motor impairment\n* History of medically uncontrolled depression or other neuropsychiatric disorders despite medications either before or after a stroke that may affect the subject's ability to participate in the study\n* History of confirmed dementia or taking dementia drugs\n* Uncontrolled hypertension despite medical treatment(s) at the time of enrollment, defined as SBP≥185 mmHg or DBP≥110 mmHg (patient can be treated, reassessed and enrolled later)\n* Presence of any MRI/TMS/LIFUS risk factors\n* Concurrent enrollment in another interventional stroke recovery study\n* Concerns that the subject cannot comply with study procedures and visits\n* Pregnant"}, 'identificationModule': {'nctId': 'NCT07220005', 'acronym': 'LIFUS-OPTIMIZE', 'briefTitle': 'Low Intensity Focused Ultrasound Stimulation in Stroke Patients - Parameter Optimization', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Low Intensity Focused Ultrasound Stimulation in Stroke Patients - Parameter Optimization', 'orgStudyIdInfo': {'id': 'Pro00117400'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ISPPA- 8 W/cm^2 (estimated intracranial spatial-peak pulse-average intensities)', 'description': 'Participant will receive ultrasound stimulation at intensity of 8 W/cm\\^2 (estimated intracranial spatial-peak pulse-average intensities, ISPPA).', 'interventionNames': ['Device: Low intensity focused ultrasound stimulation']}, {'type': 'EXPERIMENTAL', 'label': 'ISPPA- 4 W/cm^2 (estimated intracranial spatial-peak pulse-average intensities)', 'description': 'Participant will receive ultrasound stimulation at intensity of ISPPA of 4 W/cm\\^2', 'interventionNames': ['Device: Low intensity focused ultrasound stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Experimental: ISPPA- 0 W/cm^2 (estimated intracranial spatial-peak pulse-average intensities)', 'description': 'Participant will receive ultrasound stimulation at ISPPA- 0 W/cm\\^2 or sham stimulation', 'interventionNames': ['Device: Low intensity focused ultrasound stimulation']}, {'type': 'EXPERIMENTAL', 'label': 'Pulse repetition frequency(PRF) at 2000 Hz', 'description': 'each participant will receive LIFUS with pulse repetition frequency at 2000 Hz', 'interventionNames': ['Device: Low intensity focused ultrasound stimulation']}, {'type': 'EXPERIMENTAL', 'label': 'Pulse repetition frequency(PRF) at 1000 Hz', 'description': 'each participant will receive LIFUS with pulse repetition frequency at 1000 Hz', 'interventionNames': ['Device: Low intensity focused ultrasound stimulation']}, {'type': 'EXPERIMENTAL', 'label': 'Pulse repetition frequency (PRF) at 500 Hz', 'description': 'Participants will receive LIFUS with pulse repetition frequency at 500 Hz', 'interventionNames': ['Device: Low intensity focused ultrasound stimulation']}], 'interventions': [{'name': 'Low intensity focused ultrasound stimulation', 'type': 'DEVICE', 'description': 'A low-intensity focused ultrasound stimulation', 'armGroupLabels': ['Experimental: ISPPA- 0 W/cm^2 (estimated intracranial spatial-peak pulse-average intensities)', 'ISPPA- 4 W/cm^2 (estimated intracranial spatial-peak pulse-average intensities)', 'ISPPA- 8 W/cm^2 (estimated intracranial spatial-peak pulse-average intensities)', 'Pulse repetition frequency (PRF) at 500 Hz', 'Pulse repetition frequency(PRF) at 1000 Hz', 'Pulse repetition frequency(PRF) at 2000 Hz']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Megan Gonzalez, MS', 'role': 'CONTACT', 'email': 'megan.gonzalez@duke.edu', 'phone': '919-668-7597'}], 'facility': 'Duke University Hospital', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'centralContacts': [{'name': 'Clinical Research Coordinator', 'role': 'CONTACT', 'email': 'megan.gonzalez@duke.edu', 'phone': '919-668-7597'}, {'name': 'Ziping Huang, MS', 'role': 'CONTACT', 'email': 'ziping.huang@duke.edu'}], 'overallOfficials': [{'name': 'Wayne Feng, MD MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}