Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-27 @ 10:55 PM
Study NCT ID:
NCT06317194
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-05-13
First Post:
2024-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Novel Method of Non-Invasive Brain Stimulation (kTMP) to Enhance Motor Function in Chronic Stroke Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D000083302', 'term': 'Hemorrhagic Stroke'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2027-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-09', 'studyFirstSubmitDate': '2024-03-05', 'studyFirstSubmitQcDate': '2024-03-11', 'lastUpdatePostDateStruct': {'date': '2025-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fugl- Meyer Assessment (Upper Extremity)', 'timeFrame': '10 months', 'description': 'A comprehensive clinical examination that has been widely used to evaluate stroke-related motor impairment. It is graded from 0 (hemiplegia) to 66 for the Upper extremity. Higher scores signifies better motor control, and hence a better outcome.'}], 'secondaryOutcomes': [{'measure': 'Action Research Arm Test (ARAT)', 'timeFrame': '10 months', 'description': 'A standardized assessment of functional hand motor performance measured by four basic movements used in everyday life (gross arm movement, grasp, grip and pinch). The scores range from 0 to 57. Higher score means a better arm motor status.'}, {'measure': 'Modified Ashworth Scale (MAS)', 'timeFrame': '10 months', 'description': 'Used to measure spasticity in wrist and hand flexors and extensors. It assigns a grade of spasticity from 0-4. Lower scores represent normal muscle tone and higher scores represent spasticity. Hence lower scores are associated with better outcomes.'}, {'measure': 'Trial to Trial Variability (T2TV)', 'timeFrame': '10 months', 'description': 'Defined as the mean-squared error between the joint angle time-series for a given trial and the median joint angle timeseries. The median T2TV will be calculated for eleven degrees of freedom.'}, {'measure': 'Range of Joint Motion (ROM)', 'timeFrame': '10 months', 'description': 'defined as the standard deviation of the joint angle time series for a given trial. The median ROM will be calculated for eleven degrees of freedom and then averaged. If there are joints which appear to be compensatory, they will be removed from the analysis'}, {'measure': 'Grasp to Lift Time', 'timeFrame': '10 months', 'description': 'Calculated for each of three epochs, pre, during and post'}, {'measure': 'Transport Time', 'timeFrame': '10 months', 'description': 'Calculated for each of three epochs, pre, during and post'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['kTMP', 'Motor Rehabilitation', 'Ischemic Stroke', 'Hemorrhagic Stroke', 'Cerebrovascular disease', 'Cortical Excitability', 'Plasticity', 'Neuroscience', 'Stroke', 'Central Nervous System Disease', 'kilohertz Transcranial Magnetic Perturbation'], 'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'Stroke is a leading cause of disability with many patients suffering chronic motor function impairments that affect their day-to-day activities. The goal of this proposal is to provide a first assessment of the efficacy of an innovative non-invasive brain stimulation system, kTMP, in the treatment of motor impairment following stroke.', 'detailedDescription': 'The goal of this clinical trial is to test and validate a novel first-in-class non-invasive approach to enhance motor function in chronic stroke patients. The kilohertz Transcranial Magnetic Perturbation (kTMP) device allows the investigators to target frequency-specific neural activity non-invasively - with no patient discomfort - at and beyond stimulation intensities associated with enhanced recovery from stroke (up to 8 V/m), something that is not possible to achieve with existing NIBS methods.\n\nThe trial aims to evaluate the preliminary efficacy of kTMP in improving upper limb motor performance in patients suffering from chronic stroke. This clinical trial aims to target the perilesional motor cortex to assess both immediate and long-term improvement of motor performance, and corresponding physiological changes induced by kTMP stimulation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Age 18 or older with stable upper limb motor dysfunction caused by a single ischemic and/or hemorrhagic stroke greater than 6 months prior to recruitment\n2. Fugl-Meyer Assessment: Upper Extremity (FMA UE) score 28-60\n3. Motor evoked potentials in a hand muscle when stimulating ipsilesional cortex with suprathreshold single-pulse TMS (MEP+), a proxy of residual corticospinal function.\n\nExclusion criteria:\n\n1. Participants with cognitive impairment (MoCA \\< 20), language impairment that interferes with their ability to adhere to the protocol or to provide informed consent.\n2. Individuals who are pregnant, have uncontrolled medical problems including but not limited to severe cardiovascular and cardiopulmonary disease, severe alcohol or drug abuse within the past year, or major depression.\n3. Contraindications related to non-invasive brain stimulation'}, 'identificationModule': {'nctId': 'NCT06317194', 'briefTitle': 'A Novel Method of Non-Invasive Brain Stimulation (kTMP) to Enhance Motor Function in Chronic Stroke Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Magnetic Tides'}, 'officialTitle': 'A Novel Method of Non-Invasive Brain Stimulation (Kilohertz Transcranial Magnetic Perturbation) to Enhance Motor Function in Chronic Stroke Patients', 'orgStudyIdInfo': {'id': 'Magnetic Tides'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active kTMP', 'description': 'Participants received 2-8 V/m of active stimulation', 'interventionNames': ['Device: kTMP']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham kTMP', 'description': 'Participants received 0.01 V/m of sham stimulation', 'interventionNames': ['Device: Sham kTMP']}], 'interventions': [{'name': 'kTMP', 'type': 'DEVICE', 'description': 'A new non-invasive brain stimulation tool', 'armGroupLabels': ['Active kTMP']}, {'name': 'Sham kTMP', 'type': 'DEVICE', 'description': 'A new non-invasive brain stimulation tool with sham setting selected', 'armGroupLabels': ['Sham kTMP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94530', 'city': 'El Cerrito', 'state': 'California', 'country': 'United States', 'facility': 'Magnetic Tides', 'geoPoint': {'lat': 37.91576, 'lon': -122.31164}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Magnetic Tides', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of California, Berkeley', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}