Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2025-12-27 @ 5:32 AM
Study NCT ID:
NCT06265766
Status:
RECRUITING
Last Update Posted:
2025-08-27
First Post:
2024-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Brain STimulation for Arm Recovery After Stroke 2
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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Sham cTBS treatment is delivered with a sham TMS-coil.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 454}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-20', 'studyFirstSubmitDate': '2024-01-31', 'studyFirstSubmitQcDate': '2024-02-09', 'lastUpdatePostDateStruct': {'date': '2025-08-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Upper extremity section of the Fugl-Meyer Assessment', 'timeFrame': 'at 90 days post-stroke', 'description': 'The score ranges from 0 to 66 points with a higher score indicating better outcome'}], 'secondaryOutcomes': [{'measure': 'Upper extremity section of the Fugl-Meyer Assessment', 'timeFrame': 'at 12 months post-stroke', 'description': 'The score ranges from 0 to 66 points with a higher score indicating better outcome'}, {'measure': 'Action Research Arm Test', 'timeFrame': 'at 90 days and 12 months post-stroke', 'description': 'The score ranges from 0 to 57 points with a higher score indicating better outcome'}, {'measure': 'modified Rankin Scale', 'timeFrame': 'at 90 days and 12 months post-stroke', 'description': 'The score ranges from 0 to 6 points with a lower score indicating better outcome'}, {'measure': 'Hand section of Stroke Impact Scale', 'timeFrame': 'at 90 days and 12 months post-stroke', 'description': 'The score ranges from 0 to 25 points with a higher score indicating better outcome'}, {'measure': 'Participation section of Stroke Impact Scale', 'timeFrame': 'at 90 days and 12 months post-stroke', 'description': 'The score ranges from 0 to 40 points with a higher score indicating better outcome'}, {'measure': 'EuroQol-5D', 'timeFrame': 'at 90 days and 12 months post-stroke', 'description': 'The score ranges from 0 to 5 points per item with a higher score indicating better outcome'}, {'measure': 'Nine Hole Peg Test', 'timeFrame': 'at 90 days and 12 months post-stroke', 'description': 'The outcome ranges from 0 to 50 seconds with a shorter outcome indicating better outcome'}, {'measure': 'Ipsilesional corticospinal excitability', 'timeFrame': 'within 12 hours after the 10th cTBS session', 'description': 'Ipsilesional corticospinal excitability is defined as the resting motor threshold of the ipsilesional hemisphere as determined with single pulse TMS. The outcome ranges from 0 to 100% of the machine output'}, {'measure': 'iMTA medical consumption questionnaire', 'timeFrame': 'at 6 and 12 months post-stroke', 'description': 'This questionnaire aims to identify costs associated with medical consumption'}, {'measure': 'iMTA productivity cost questionnaire', 'timeFrame': 'At 6 and 12 months post-stroke', 'description': 'This questionnaire aims to identify costs associated with productivity loss of paid work.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stroke', 'Transcranial magnetic stimulation', 'Continuous theta burst stimulation', 'Upper limb recovery', 'TMS', 'cTBS'], 'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'Rationale: Every year, about 40,000 people in the Netherlands have a stroke. After the initial admission to the hospital, about 15% of stroke survivors is admitted to a rehabilitation center because of remaining disabilities. Three out of four of these patients have upper limb dysfunction, hampering activities of daily living. Upper limb function plays a critical role in the performance of most daily life activities. In our phase II trial B-STARS, continuous theta burst stimulation (cTBS) treatment led to an absolute additional recovery of upper limb function of 17%, as measured with the Action Research Arm Test (ARAT) score three months after stroke. This improvement exceeds the minimal clinically important difference of 10%. cTBS treatment also resulted in a significant improvement in measures of activities and participation (of similar magnitude) and a reduction in the mean length of stay at the rehabilitation center by 18 days.\n\nObjective: To assess the effectiveness and cost effectiveness of cTBS treatment in promoting upper limb recovery after stroke in patients admitted to a rehabilitation center.\n\nStudy design: A phase III, multi-center, double-blind, randomized, sham-controlled, clinical trial.\n\nStudy population: 454 patients aged 18 years or older with a first-ever ischemic stroke or intracerebral hemorrhage and a unilateral arm paresis, defined by a Motricity Index between 9 and 99, in whom cTBS treatment can be started within 3 weeks after stroke onset.\n\nIntervention: 10 daily sessions of cTBS delivered over the contralesional primary motor cortex during a period of 2 weeks, delivered immediately before regular care physical therapy of the affected upper limb.\n\nMain study parameters/endpoints: The primary endpoint will be the score on the upper extremity section of the Fugl-Meyer assessment (FM-UE) at 90 days after stroke. Secondary endpoints will include the score on the FM-UE at one year and the scores on the Action Research Arm Test, Nine Hole Peg Test, Stroke Impact Scale, EuroQol 5 Dimensions and modified Rankin Scale at 90 days and one year after stroke'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age, 18 years or older\n* First-ever unilateral ischemic stroke or intracerebral hemorrhage in a cerebral hemisphere or the brainstem;\n* Unilateral upper limb paresis with a motricity index between 9 and 99;\n* Possibility to start cTBS treatment within 21 days after stroke onset;\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Upper limb paresis prior to stroke onset;\n* Absolute contra-indication to TMS\n* Magnetic sensitive objects implanted in the head or neck area (e.g. cochlear implants, implanted neurostimulator, pacemaker or defibrillator, metal splinters, metal fragments or metal clips);\n* History of epilepsy;\n* Other contra-indications that may potentially be harmful as determined by the treating rehabilitation physician;\n* Severe impairments that can impede study participation as determined by the treating rehabilitation physician (i.e. extreme fatigue, severe communication deficits);\n* Life expectancy shorter than one year.'}, 'identificationModule': {'nctId': 'NCT06265766', 'acronym': 'B-STARS2', 'briefTitle': 'Brain STimulation for Arm Recovery After Stroke 2', 'organization': {'class': 'OTHER', 'fullName': 'UMC Utrecht'}, 'officialTitle': 'Brain STimulation for Arm Recovery After Stroke 2', 'orgStudyIdInfo': {'id': 'NL85511.041.24'}, 'secondaryIdInfos': [{'id': '85511', 'type': 'OTHER', 'domain': 'ABR number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active cTBS', 'description': 'Active cTBS delivered with an active TMS coil', 'interventionNames': ['Device: Active cTBS']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham cTBS', 'description': 'Sham cTBS delivered with a sham TMS coil', 'interventionNames': ['Device: Sham cTBS']}], 'interventions': [{'name': 'Active cTBS', 'type': 'DEVICE', 'description': '10 sessions of active cTBS delivered to the contralesional primary motor cortex, started within 3 weeks after stroke.', 'armGroupLabels': ['Active cTBS']}, {'name': 'Sham cTBS', 'type': 'DEVICE', 'description': '10 sessions of sham cTBS delivered to the contralesional primary motor cortex, started within 3 weeks after stroke.', 'armGroupLabels': ['Sham cTBS']}]}, 'contactsLocationsModule': {'locations': [{'city': "'s-Hertogenbosch", 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Cynthia Klinkers', 'role': 'CONTACT'}], 'facility': 'Tolbrug', 'geoPoint': {'lat': 51.69917, 'lon': 5.30417}}, {'city': 'Amsterdam', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Celine Timmermans', 'role': 'CONTACT', 'email': 'c.timmermans@reade.nl'}], 'facility': 'Reade', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Beetsterzwaag', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Wietske Rienstra', 'role': 'CONTACT', 'email': 'w.rienstra@revalidatie-friesland.nl'}], 'facility': 'Revalidatie Friesland', 'geoPoint': {'lat': 53.05914, 'lon': 6.07711}}, {'city': 'Breda', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Marissa Riemens', 'role': 'CONTACT'}], 'facility': 'Revant', 'geoPoint': {'lat': 51.58656, 'lon': 4.77596}}, {'city': 'Doorn', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Lisa Kruisheer', 'role': 'CONTACT'}], 'facility': 'MRC Aardenburg', 'geoPoint': {'lat': 52.03343, 'lon': 5.34571}}, {'city': 'Eindhoven', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Daphne Stranders', 'role': 'CONTACT'}], 'facility': 'Libra Blixembosch', 'geoPoint': {'lat': 51.44083, 'lon': 5.47778}}, {'city': 'Groesbeek', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Henk Meulenbelt', 'role': 'CONTACT'}], 'facility': 'University Medical Center Groningen', 'geoPoint': {'lat': 51.77667, 'lon': 5.93611}}, {'city': 'Hilversum', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Maijke van Bloemendaal', 'role': 'CONTACT'}, {'name': 'Karin Peek', 'role': 'CONTACT'}], 'facility': 'Merem', 'geoPoint': {'lat': 52.22333, 'lon': 5.17639}}, {'city': 'Hoensbroek', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Carlijn Wiertz', 'role': 'CONTACT', 'email': 'Carlijn.Wiertz@adelantegroep.nl', 'phone': '+31 45 528 2828'}], 'facility': 'Adelante', 'geoPoint': {'lat': 50.92387, 'lon': 5.92528}}, {'city': 'Leiden', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Annelies Mantje', 'role': 'CONTACT'}], 'facility': 'Basalt', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}, {'city': 'Nijmegen', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Nelleke Kooiman', 'role': 'CONTACT'}], 'facility': 'Sint Maartenskliniek', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'city': 'The Hague', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Lotte Mulder', 'role': 'CONTACT', 'email': 'l.mulder@basaltrevalidatie.nl', 'phone': '0031703593500'}], 'facility': 'Basalt', 'geoPoint': {'lat': 52.07667, 'lon': 4.29861}}, {'city': 'Tilburg', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Iris Habets', 'role': 'CONTACT'}], 'facility': 'Libra Leijpark', 'geoPoint': {'lat': 51.55551, 'lon': 5.0913}}, {'city': 'Utrecht', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Mirjam Kouwenhoven', 'role': 'CONTACT'}], 'facility': 'De Hoogstraat', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}, {'city': 'Wijk aan Zee', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Deborah Wit', 'role': 'CONTACT'}], 'facility': 'Heliomare', 'geoPoint': {'lat': 52.4936, 'lon': 4.59409}}, {'city': 'Zwolle', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Bente Visser', 'role': 'CONTACT'}], 'facility': 'Vogellanden', 'geoPoint': {'lat': 52.5125, 'lon': 6.09444}}], 'centralContacts': [{'name': 'Jord Vink, PhD', 'role': 'CONTACT', 'email': 'j.j.vink-5@umcutrecht.nl', 'phone': '+31634959811'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Anonymized patient data can be made available on request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jord Vink', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'dr.', 'investigatorFullName': 'Jord Vink', 'investigatorAffiliation': 'UMC Utrecht'}}}}