Ignite Creation Date:
2025-12-24 @ 2:20 PM
Ignite Modification Date:
2026-01-21 @ 2:14 AM
Study NCT ID:
NCT07277595
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-11
First Post:
2025-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
kTMP in Chronic Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2030-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2025-12-02', 'studyFirstSubmitQcDate': '2025-12-02', 'lastUpdatePostDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2030-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fugl Meyer Assessment', 'timeFrame': 'Enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34.', 'description': 'The Fugl-Meyer Assessment (FMA) is a structured evaluation used to measure motor recovery after a stroke, with a total score range of 0-226. Higher scores indicate better motor function, while lower scores reflect greater impairment.'}], 'secondaryOutcomes': [{'measure': 'Wolf Motor Function Test', 'timeFrame': 'At enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34', 'description': 'Measures timed functional tasks, strength testing, and analysis of movement quality when completing various upper extremity tasks. Uses a 6 point ordinal scale (0-5), where ) is does not attempt with the involved arm and 5 is arm does participate and movement appears normal. Maximum score of 75. Lower scores indicate lower functional levels.'}, {'measure': 'Stroke Impact Scale', 'timeFrame': 'At enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34', 'description': 'Self reported questionnaire that evaluates disability and health related quality of life after stroke, consisting of 59 items, assessing strength, hand function, ADL/iADL, mobility, communication, emotion, memory and thinking, participation/role function. Each item is rated in a 5 point Likert scale, where 1 equals could not do it at all and 5 equals not difficult at all. Score ranges 0-100. Higher score indicates less disability and high quality of life after stroke.'}, {'measure': 'Stroke Specific QOL', 'timeFrame': 'At enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34', 'description': "Questionnaire consisting of 49 items in the 12 domains of mobility, energy, upper extremity function, work and productivity, mood, self-care, social roles, family roles, vision, language, thinking and personality. Each item is assessed on a 5 point Guttman type scale, where 1=total help; couldn't do it at all; strongly agree and 5 =no help needed; no trouble at all; strongly disagree. Higher scores indicate better functioning."}, {'measure': 'EuroQOL', 'timeFrame': 'At enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34', 'description': 'A health questionnaire that measures 5 dimensions including mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each item is described by 3 levels of problems, where 1=none, 2=mild to moderate, and 3=severe. This provides a simple single index value for health status, where a higher score indicates worse health state.'}, {'measure': 'Motor Activity Log', 'timeFrame': 'At enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34', 'description': 'Self reported perception of Quality of movement are rated in 30 functional tasks, scored on a 6 point ordinal scale where 0=weaker arm not used at all for that activity and 5=ability to use the weaker arm for that activity is as good as before the stroke(normal). A higher score indicates better quality upper extremity movement.'}, {'measure': 'Modified Ashworth Scale Scores', 'timeFrame': 'At enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34', 'description': 'Test of resistance to passive movement about a joint, scores range from 0 to 5 where 0=no increase in muscle tone and 5=affected part(s) rigid. Hight scores indicate greater muscle tone.'}, {'measure': 'Action Research Arm Test', 'timeFrame': 'At enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34', 'description': 'Measures performance of the upper extremity in grasp, grip, pinch, and gross arm movements, rated on a 4 point ordinal scale where 3=performs test normally and 0=can perform no part of test. Higher score indicates greater function of the upper extremity.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['transcranial magnetic stimulation'], 'conditions': ['Stroke', 'Chronic Stroke Patients', 'Arm Weakness as a Consequence of Stroke']}, 'descriptionModule': {'briefSummary': 'kTMP, kilohertz transcutaneous magnetic perturbations, is a low intensity transcranial magnetic stimulation technique that will be used in this study to promote arm/hand rehabilitation in patients who have been disabled by stroke.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults age 18-80 years old who have had a stroke resulting in hemiplegia\n* Ability to communicate, understand, and give appropriate consent\n* Other criteria may apply\n\nExclusion Criteria:\n\n* Significant cognitive impairment\n* inability to adhere to the study protocol or provide informed consent\n* pregnancy\n* additional criteria may apply'}, 'identificationModule': {'nctId': 'NCT07277595', 'acronym': 'KULMINATE', 'briefTitle': 'kTMP in Chronic Stroke', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'KTMP: A Novel Method of Non-invasive Brain Stimulation to Enhance Motor Function in Chronic Stroke Patients.', 'orgStudyIdInfo': {'id': '25-43524'}, 'secondaryIdInfos': [{'id': 'R44NS139730', 'link': 'https://reporter.nih.gov/quickSearch/R44NS139730', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active Treatment', 'description': 'Active treatment with kTMP for 18 weeks', 'interventionNames': ['Device: kTMP 18 weeks']}, {'type': 'OTHER', 'label': 'Crossover Treatment', 'description': 'Initial 9 weeks will receive sham kTMP treatment, followed by 9 weeks of active kTMP treatment.', 'interventionNames': ['Device: kTMP sham stimulation 9 weeks + active stimulation 9 weeks']}], 'interventions': [{'name': 'kTMP sham stimulation 9 weeks + active stimulation 9 weeks', 'type': 'DEVICE', 'description': 'kTMP 9 weeks sham-kTMP stimulation, followed by 9 weeks active kTMP stimulation', 'armGroupLabels': ['Crossover Treatment']}, {'name': 'kTMP 18 weeks', 'type': 'DEVICE', 'description': 'Participants receive kTMP active stimulation for 18 weeks', 'armGroupLabels': ['Active Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94158', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'centralContacts': [{'name': 'Karunesh Ganguly, MD, PhD', 'role': 'CONTACT', 'email': 'karunesh.ganguly@ucsf.edu', 'phone': '415-514-1252'}], 'overallOfficials': [{'name': 'Karunesh Ganguly, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Neurological Disorders and Stroke (NINDS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}