protocolSection identificationModule nctId: NCT06265766, orgStudyIdInfo id: NL85511.041.24, secondaryIdInfos id: 85511, type: OTHER, domain: ABR number, briefTitle: Brain STimulation for Arm Recovery After Stroke 2, acronym: B-STARS2, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2029-03-31, completionDateStruct date: 2029-12-31, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Jord Vink, class: OTHER, 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.Objective: To assess the effectiveness and cost effectiveness of cTBS treatment in promoting upper limb recovery after stroke in patients admitted to a rehabilitation center.Study design: A phase III, multi-center, double-blind, randomized, sham-controlled, clinical trial.Study 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.Intervention: 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.Main 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, conditionsModule conditions: Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Sham cTBS treatment is delivered with a sham TMS-coil., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 454, type: ESTIMATED, armsInterventionsModule interventions name: cTBS, outcomesModule primaryOutcomes measure: Upper extremity section of the Fugl-Meyer Assessment, secondaryOutcomes measure: Upper extremity section of the Fugl-Meyer Assessment, secondaryOutcomes measure: Action Research Arm Test, secondaryOutcomes measure: modified Rankin Scale, secondaryOutcomes measure: Hand section of Stroke Impact Scale, secondaryOutcomes measure: Participation section of Stroke Impact Scale, secondaryOutcomes measure: EuroQol-5D, secondaryOutcomes measure: Nine Hole Peg Test, secondaryOutcomes measure: Ipsilesional corticospinal excitability, secondaryOutcomes measure: iMTA medical consumption and productivity cost questionnaire, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Reade, city: Amsterdam, country: Netherlands, contacts name: Marijn Mulder-Kampen, role: CONTACT, geoPoint lat: 52.37403, lon: 4.88969, locations facility: Revalidatie Friesland, city: Beetsterzwaag, country: Netherlands, contacts name: Wietske Rienstra, role: CONTACT, geoPoint lat: 53.05914, lon: 6.07711, locations facility: Revant, city: Breda, country: Netherlands, contacts name: Marissa Riemens, role: CONTACT, geoPoint lat: 51.58656, lon: 4.77596, locations facility: Tolbrug, city: Den Bosch, country: Netherlands, contacts name: Cynthia Klinkers, role: CONTACT, geoPoint lat: 51.27, lon: 5.59167, locations facility: Basalt, city: Den Haag, country: Netherlands, contacts name: Kangdi Zhu, role: CONTACT, geoPoint lat: 52.07667, lon: 4.29861, locations facility: MRC Aardenburg, city: Doorn, country: Netherlands, contacts name: Lisa Kruisheer, role: CONTACT, geoPoint lat: 52.03343, lon: 5.34571, locations facility: Libra Blixembosch, city: Eindhoven, country: Netherlands, contacts name: Daphne Stranders, role: CONTACT, geoPoint lat: 51.44083, lon: 5.47778, locations facility: University Medical Center Groningen, city: Groesbeek, country: Netherlands, contacts name: Henk Meulenbelt, role: CONTACT, geoPoint lat: 51.77667, lon: 5.93611, locations facility: Merem, city: Hilversum, country: Netherlands, contacts name: Maijke van Bloemendaal, role: CONTACT, contacts name: Karin Peek, role: CONTACT, geoPoint lat: 52.22333, lon: 5.17639, locations facility: Adelante, city: Hoensbroek, country: Netherlands, geoPoint lat: 50.92387, lon: 5.92528, locations facility: Basalt, city: Leiden, country: Netherlands, contacts name: Annelies Mantje, role: CONTACT, geoPoint lat: 52.15833, lon: 4.49306, locations facility: Sint Maartenskliniek, city: Nijmegen, country: Netherlands, contacts name: Nelleke Kooiman, role: CONTACT, geoPoint lat: 51.8425, lon: 5.85278, locations facility: Libra Leijpark, city: Tilburg, country: Netherlands, contacts name: Iris Habets, role: CONTACT, geoPoint lat: 51.55551, lon: 5.0913, locations facility: De Hoogstraat, city: Utrecht, country: Netherlands, contacts name: Mirjam Kouwenhoven, role: CONTACT, geoPoint lat: 52.09083, lon: 5.12222, locations facility: Heliomare, city: Wijk Aan Zee, country: Netherlands, contacts name: Deborah Wit, role: CONTACT, geoPoint lat: 52.4936, lon: 4.59409, locations facility: Vogellanden, city: Zwolle, country: Netherlands, contacts name: Bente Visser, role: CONTACT, geoPoint lat: 52.5125, lon: 6.09444, hasResults: False