[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100555261":3},{"organization":4,"outcomesModule":7,"designInfo":24,"detailedDescription":33,"studyPopulation":23,"armGroups":34,"interventions":55,"overallOfficials":23,"centralContacts":23,"locations":61,"responsibleParty":80,"collaborators":82,"id":85,"slug":86,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":23,"eligibilityCriteria":91,"healthyVolunteers":87,"sex":92,"minAge":93,"maxAge":94,"enrollmentInfo":95,"targetDuration":23,"studyType":98,"phases":99,"briefSummary":33,"conditions":101,"keywords":103,"overallStatus":64,"whyStopped":23,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"The Hong Kong Polytechnic University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":23},[9,13,15],{"measure":10,"description":11,"timeFrame":12},"The Fugl-Meyer Assessment-Upper Extremity Scores","The Fugl-Meyer Assessment-Upper Extremity Scores (FMA-UE) is the gold standard for evaluating poststroke upper limb motor control. This assessment is used to determine the movement, coordination, and reflex actions of the hemiplegic upper limb","Baseline",{"measure":10,"description":11,"timeFrame":14},"At 3 weeks",{"measure":10,"description":11,"timeFrame":16},"At one-month",[18,21,22],{"measure":19,"description":20,"timeFrame":12},"P30 amplitude in the TMS-evoked potential","TMS-evoked potential is a time-locked signal elicited by single TMS pulses delivered to the cortex. P30 means the positive peak appeared at 30 ms after stimulation. The amplitude of P30 is correlated with cortical excitability mediated by excitatory interneurons.",{"measure":19,"description":20,"timeFrame":14},{"measure":19,"description":20,"timeFrame":16},null,{"allocation":25,"interventionModel":26,"interventionModelDescription":23,"primaryPurpose":27,"observationalModel":23,"timePerspective":23,"maskingInfo":28},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":29,"maskingDescription":23,"whoMasked":30},"DOUBLE",[31,32],"PARTICIPANT","OUTCOMES_ASSESSOR","Objectives: To compare the effects of low intensity priming intermittent theta burst stimulation (iTBS) with those derived from conventional intensity priming iTBS, nonpriming iTBS, and sham stimulation in terms of improving hemiparetic upper limb motor functionality and modulating cortical excitation\u002Finhibition in patients with stroke.\n\nHypothesis to be tested: We hypothesize that low intensity priming iTBS can maximize the induction of therapeutically beneficial metaplasticity, and that this will be reflected in enhanced cortical excitation and reduced cortical inhibition, thereby enabling superior upper limb motor recovery in patients with stroke.\n\nDesign and subjects: A randomized controlled trial involving 108 patients with chronic stroke.\n\nStudy instruments: Transcranial magnetic stimulation (TMS) and electroencephalography (EEG).\n\nInterventions: Participants will be randomly assigned into one of the following four groups: (1) low intensity priming iTBS (55% resting motor threshold \\[RMT\\] continuous theta burst stimulation \\[cTBS\\]+70% RMT iTBS); (2) conventional intensity priming iTBS (70% RMT cTBS+70% RMT iTBS); (3) nonpriming iTBS (sham cTBS+70% RMT iTBS); and (4) sham stimulation (sham cTBS+sham iTBS). All participants will receive 60-minute standard motor training after completion of the stimulation program. The intervention will last four weeks, with three sessions per week.\n\nMain outcome measures: Upper limb motor tests and levels of cortical excitation\u002Finhibition measured by TMS-evoked EEG potentials.\n\nData analysis: Analysis of variance (ANOVA). Expected results: The low intensity priming iTBS protocol will be the most efficacious protocol for enhancing cortical excitation and reducing cortical inhibition in post-stroke patients and will thereby produce superior outcomes with regard to upper limb motor functionality.",[35,41,45,50],{"label":36,"type":37,"description":38,"interventionNames":39},"Low intensity priming intermittent theta burst stimulation (iTBS)","EXPERIMENTAL","Standard 600-pulse TBS will be applied using the MagPro X100 stimulator (MagVenture, Denmark) connected with a figure-of-eight coil (Cooling B-65). The resting motor threshold (RMT) of the motor cortex (M1) will be defined as the minimum intensity over the motor hotspot that could elicit an motor evoked potential (MEP) of no less than 50 μv over the first dorsal interosseous muscle in at least five out of 10 trials. Low intensity priming iTBS consists of a session of 55% RMT cTBS, followed by 70% RMT iTBS.",[40],"Device: Transcranial magnetic stimulation (TMS) - Theta burst stimulation (TBS) protocol",{"label":42,"type":37,"description":43,"interventionNames":44},"Standard priming intermittent theta burst stimulation (iTBS)","Standard 600-pulse TBS will be applied using the MagPro X100 stimulator (MagVenture, Denmark) connected with a figure-of-eight coil (Cooling B-65). The resting motor threshold (RMT) of the motor cortex (M1) will be defined as the minimum intensity over the motor hotspot that could elicit an motor evoked potential (MEP) of no less than 50 μv over the first dorsal interosseous muscle in at least five out of 10 trials. Standard priming iTBS consists of a session of 70% RMT cTBS, followed by 70% RMT iTBS.",[40],{"label":46,"type":47,"description":48,"interventionNames":49},"Nonpriming intermittent theta burst stimulation (iTBS)","ACTIVE_COMPARATOR","Standard 600-pulse TBS will be applied using the MagPro X100 stimulator (MagVenture, Denmark) connected with a figure-of-eight coil (Cooling B-65). The resting motor threshold (RMT) of the motor cortex (M1) will be defined as the minimum intensity over the motor hotspot that could elicit an motor evoked potential (MEP) of no less than 50 μv over the first dorsal interosseous muscle in at least five out of 10 trials. Nonpriming iTBS consists of a session of 20% RMT cTBS (sham), followed by 70% RMT iTBS.",[40],{"label":51,"type":52,"description":53,"interventionNames":54},"Sham stimulation","SHAM_COMPARATOR","Standard 600-pulse TBS will be applied using the MagPro X100 stimulator (MagVenture, Denmark) connected with a figure-of-eight coil (Cooling B-65). The resting motor threshold (RMT) of the motor cortex (M1) will be defined as the minimum intensity over the motor hotspot that could elicit an motor evoked potential (MEP) of no less than 50 μv over the first dorsal interosseous muscle in at least five out of 10 trials. Sham stimulation consists of a session of 20% RMT cTBS (sham), followed by 20% RMT iTBS (sham).",[40],[56],{"type":57,"name":58,"description":59,"armGroupLabels":60,"otherNames":23},"DEVICE","Transcranial magnetic stimulation (TMS) - Theta burst stimulation (TBS) protocol","This procedure uses magnetic fields to stimulate nerve cells in the brain involved in various neurological functions, such as motor control. Theta burst stimulation is a patterned form of TMS protocol.",[36,46,51,42],[62],{"facility":63,"status":64,"city":65,"state":65,"zip":66,"country":65,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"Jack Jiaqi Zhang","RECRUITING","Hong Kong","000000","HK",{"type":69,"coordinates":70},"Point",[71,72],114.17469,22.27832,{"lat":72,"lon":71},[75],{"name":76,"role":77,"phone":78,"phoneExt":23,"email":79},"Jack Jiaqi Zhang, PhD, HKROT","CONTACT","27666696","jack-jq.zhang@connect.polyu.hk",{"type":81,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR",[83],{"name":84,"class":6},"Tung Wah Hospital","100555261","priming-theta-burst-stimulation-for-stroke-a-study-of-intensity-100555261",false,"NCT06509789","Priming Theta Burst Stimulation for Stroke: A Study of Intensity","Optimizing the Intensity of Priming Theta Burst Stimulation to Improve Hemiparetic Upper Limb Motor Functions After Stroke: a Randomized Controlled Trial","Inclusion Criteria\n\n1. Unilateral upper limb motor dysfunction caused by ischemic or hemorrhagic stroke, with stroke onset≥6 months. Diagnosis will be verified using discharge summary and radiological reports issued by Hospital Authority. Qualifying participants will undergo structural magnetic resonance imaging (MRI) at the University Research Facility in Behavioral and Systems Neuroscience (UBSN) at PolyU to further confirm their lesion location in the period of experimental participation.\n2. Age between 18 and 80 years.\n3. Residual upper limb functions between levels 2-7 in the FTHUE, indicating moderately-to-severely impaired upper limb motor functions.\n4. Capable of providing informed written consent. Exclusion Criteria\n\nPatients who meet any of the following criteria will be excluded:\n\n1. any contraindications to TMS (screened by the safety checklist by Rossi(33)) and\u002For MRI (screened by the MRI safety checklist offered by UBSN \\[see supplement\\]).\n2. Diagnosed with any concomitant neurological disease other than stroke.\n3. signs of cognitive impairment, with a Montreal cognitive assessment score\\\u003C21\u002F22 out of 30 (34).\n4. Severe spasticity in the hemiparetic upper limb muscles, with a Modified Ashworth score \\> 2 (35).","ALL","18 Years","80 Years",{"count":96,"type":97},100,"ESTIMATED","INTERVENTIONAL",[100],"NA",[102],"Stroke",[102,104,105],"Transcranial magnetic stimulation","Theta burst stimulation","2026-08-21",{"date":108,"type":109},"2026-08-24","ACTUAL",{"date":111,"type":109},"2025-07-02",{"date":113,"type":97},"2027-09-30",{"name":5,"class":6},1]