[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639376":3},{"organization":4,"outcomesModule":7,"designInfo":91,"detailedDescription":94,"studyPopulation":94,"armGroups":98,"interventions":111,"overallOfficials":122,"centralContacts":126,"locations":94,"responsibleParty":132,"collaborators":94,"id":134,"slug":94,"hasResults":135,"nctId":136,"briefTitle":137,"officialTitle":137,"acronym":138,"eligibilityCriteria":139,"healthyVolunteers":135,"sex":140,"minAge":141,"maxAge":142,"enrollmentInfo":143,"targetDuration":94,"studyType":146,"phases":147,"briefSummary":149,"conditions":150,"keywords":94,"overallStatus":152,"whyStopped":94,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":94},{"fullName":5,"class":6},"Shandong Provincial Hospital","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":43},[9],{"measure":10,"description":11,"timeFrame":12},"Change in Fugl-Meyer Assessment for Upper Extremity (FMA-UE) score","Change is calculated as the Day 30 FMA-UE score minus the baseline (T0) FMA-UE score. Higher positive values indicate greater improvement in upper-extremity motor function. T0 is defined as 48 hours after IVT for the IVT-only pathway, and Day 5 (120 ± 24 hours) after MT for the MT ± IVT pathway.","Baseline (T0), Day 30",[14,18,21,24,27,30,33,36,40],{"measure":15,"description":16,"timeFrame":17},"Fugl-Meyer Assessment for Upper Extremity (FMA-UE) score","Upper-extremity motor impairment assessed using the Fugl-Meyer Assessment for Upper Extremity. Higher scores indicate better upper-extremity motor function.","Day 10 (±2 days), Day 30, Day 90",{"measure":19,"description":20,"timeFrame":17},"Action Research Arm Test (ARAT) score","Upper-limb activity limitation assessed using the Action Research Arm Test. Higher scores indicate better upper-limb function.",{"measure":22,"description":23,"timeFrame":17},"Fugl-Meyer Assessment for Lower Extremity (FMA-LE) score","Lower-extremity motor impairment assessed using the Fugl-Meyer Assessment for Lower Extremity. Higher scores indicate better lower-extremity motor function.",{"measure":25,"description":26,"timeFrame":17},"Functional Ambulation Category (FAC) score","Walking ability assessed using the Functional Ambulation Category. Higher scores indicate greater independence in ambulation.",{"measure":28,"description":29,"timeFrame":17},"10-Meter Walk Test (10MWT) performance","Walking performance assessed by the 10-Meter Walk Test in participants who meet prespecified walking criteria. Walking speed and\u002For time required to complete the test will be recorded.",{"measure":31,"description":32,"timeFrame":17},"Timed Up and Go (TUG) test performance","Functional mobility assessed by the Timed Up and Go test in participants who meet prespecified walking criteria. Time required to complete the test will be recorded.",{"measure":34,"description":35,"timeFrame":17},"National Institutes of Health Stroke Scale (NIHSS) score","Neurological deficit severity assessed using the National Institutes of Health Stroke Scale. Lower scores indicate less severe neurological impairment.",{"measure":37,"description":38,"timeFrame":39},"Modified Rankin Scale (mRS) score","Global disability assessed using the modified Rankin Scale. Lower scores indicate less disability and greater functional independence.","Day 30, Day 90",{"measure":41,"description":42,"timeFrame":17},"Barthel Index (BI) \u002F Modified Barthel Index (MBI) score","Activities of daily living assessed using the Barthel Index or Modified Barthel Index, according to the scale used at each study site. Higher scores indicate better functional independence in daily activities.",[44,48,52,55,58,62,66,70,73,76,79,82,85,88],{"measure":45,"description":46,"timeFrame":47},"Screening-to-enrollment ratio","Feasibility outcome defined as the number of participants enrolled and randomized divided by the total number of participants screened.","Through completion of recruitment, an estimated 16 months",{"measure":49,"description":50,"timeFrame":51},"Intervention adherence rate","Feasibility outcome defined as the proportion of planned training sessions completed by each participant.","During the 5-day intervention period",{"measure":53,"description":54,"timeFrame":51},"Effective BCI training duration","Feasibility outcome defined as the cumulative duration of valid BCI training completed during the intervention period.",{"measure":56,"description":57,"timeFrame":51},"EEG signal quality and classification accuracy","Feasibility outcome assessing the quality of EEG acquisition and the performance of signal classification during BCI training sessions.",{"measure":59,"description":60,"timeFrame":61},"Follow-up completion rate","Feasibility outcome defined as the proportion of randomized participants who complete scheduled outcome assessments through Day 90.","Through Day 90",{"measure":63,"description":64,"timeFrame":65},"Protocol deviation rate","Feasibility outcome defined as the proportion of participants with one or more protocol deviations.","From randomization through Day 90",{"measure":67,"description":68,"timeFrame":69},"Incidence of symptomatic intracranial hemorrhage","Safety outcome defined as the occurrence of symptomatic intracranial hemorrhage after study enrollment.","From T0 through Day 30",{"measure":71,"description":72,"timeFrame":69},"Incidence of any intracranial hemorrhage","Safety outcome defined as the occurrence of any type of intracranial hemorrhage after study enrollment.",{"measure":74,"description":75,"timeFrame":69},"Incidence of neurological deterioration","Safety outcome defined as clinical neurological worsening after study enrollment according to the study protocol.",{"measure":77,"description":78,"timeFrame":69},"Incidence of seizures","Safety outcome defined as the occurrence of seizure events after study enrollment.",{"measure":80,"description":81,"timeFrame":69},"Incidence of falls","Safety outcome defined as the occurrence of falls during the study period.",{"measure":83,"description":84,"timeFrame":69},"Incidence of blood pressure or cardiac rhythm adverse events","Safety outcome defined as blood pressure instability or cardiac arrhythmia events occurring during the study period.",{"measure":86,"description":87,"timeFrame":69},"Incidence of puncture-site bleeding or hematoma","Safety outcome assessed in participants in the MT pathway, defined as puncture-site bleeding or hematoma after mechanical thrombectomy.",{"measure":89,"description":90,"timeFrame":51},"Incidence of training-related discomfort","Safety outcome defined as training-related discomfort, including fatigue, headache, skin irritation, or other reported discomfort associated with the intervention.",{"allocation":92,"interventionModel":93,"interventionModelDescription":94,"primaryPurpose":95,"observationalModel":94,"timePerspective":94,"maskingInfo":96},"RANDOMIZED","PARALLEL",null,"TREATMENT",{"masking":97,"maskingDescription":94,"whoMasked":94},"NONE",[99,106],{"label":100,"type":101,"description":102,"interventionNames":103},"Experimental BCI Rehabilitation Group","EXPERIMENTAL","Standard early rehabilitation plus early EEG-BCI dual-module virtual hand and gait training",[104,105],"Device: EEG-based non-invasive brain-computer interface (BCI) virtual hand\u002Fgait training system","Behavioral: Standard Early Rehabilitation",{"label":107,"type":108,"description":109,"interventionNames":110},"Standard Early Rehabilitation Group","ACTIVE_COMPARATOR","Standard early rehabilitation without additional BCI training.",[105],[112,117],{"type":113,"name":114,"description":115,"armGroupLabels":116,"otherNames":94},"DEVICE","EEG-based non-invasive brain-computer interface (BCI) virtual hand\u002Fgait training system","Closed-loop EEG-based non-invasive brain-computer interface training added to standard early rehabilitation, including virtual hand training for the upper limb and gait\u002Fankle dorsiflexion training for the lower limb. Training is delivered twice daily, approximately 20 minutes per session, for 5 consecutive days.",[100],{"type":118,"name":119,"description":120,"armGroupLabels":121,"otherNames":94},"BEHAVIORAL","Standard Early Rehabilitation","Participants receive site-standard early rehabilitation according to the local rehabilitation protocol.",[100,107],[123],{"name":124,"affiliation":5,"role":125},"QinJian Sun, MD","PRINCIPAL_INVESTIGATOR",[127],{"name":128,"role":129,"phone":130,"phoneExt":94,"email":131},"Wang Chen, MD","CONTACT","+86-68773274","chenwang@sph.com.cn",{"type":133,"investigatorFullName":94,"investigatorTitle":94,"investigatorAffiliation":94,"oldNameTitle":94,"oldOrganization":94},"SPONSOR","100639376",false,"NCT07585058","Safety and Efficacy of Early Brain-Computer Interface Training After Reperfusion Therapy in Acute Ischemic Stroke","RT-BCI","Inclusion Criteria:\n\n* 1\\. Age 18 to 80 years.\n* 2\\. Acute ischemic stroke (AIS) treated with reperfusion therapy, including intravenous thrombolysis (IVT) and\u002For mechanical thrombectomy (MT); for participants undergoing MT, successful recanalization during the procedure defined as eTICI 2b-3.\n* 3\\. Meets the protocol-defined clinical stability criteria for the corresponding treatment pathway (see Section 4.3).\n* 4\\. Unilateral limb motor dysfunction on the same side as the dominant hand.\n* 5\\. Fugl-Meyer Assessment for Upper Extremity (FMA-UE) score of 10 to 50 at T0.\n* 6\\. Pre-stroke modified Rankin Scale (mRS) score \\\u003C= 2.\n* 7\\. Written informed consent provided by the participant and ability to comply with training and follow-up; if necessary, consent may be provided by a legally authorized representative.\n\nExclusion Criteria:\n\n* 1\\. Imaging-confirmed symptomatic intracranial hemorrhage (sICH), or bleeding risk considered unacceptable by the investigator and requiring a change in treatment strategy.\n* 2\\. Overt progressive neurological deterioration or need for urgent intervention, making training inappropriate, such as an increase in National Institutes of Health Stroke Scale (NIHSS) score of \\>=4 from a prior assessment with cause not yet clarified or stabilized.\n* 3\\. Severe disturbance of consciousness, severe aphasia or neglect, or significant cognitive impairment that would prevent completion of BCI training tasks or primary outcome assessment.\n* 4\\. Bilateral significant motor impairment, such as brainstem or bilateral lesions, or pre-existing moderate-to-severe disability of the contralateral upper or lower limb, which would interfere with training or interpretation of assessments under the unilateral impairment framework.\n* 5\\. Severe comorbidity or unstable vital signs, including but not limited to unstable arrhythmia, severe heart failure or respiratory failure, active severe infection or sepsis, or severe hepatic or renal failure, such that the investigator judges the participant unable to safely complete training and follow-up.\n* 6\\. Severe scalp skin damage or infection, or any other condition preventing safe use of the EEG electrode cap.\n* 7\\. Frequent seizures within 7 days before randomization, or seizure risk considered unacceptable by the investigator.\n* 8\\. Pregnancy or breastfeeding.\n* 9\\. Participation in another interventional clinical study that may affect the outcomes of this study, or any other condition that, in the investigator's judgment, makes the participant unsuitable for enrollment.","ALL","18 Years","80 Years",{"count":144,"type":145},60,"ESTIMATED","INTERVENTIONAL",[148],"NA","This is a multicenter, prospective, randomized controlled trial designed to evaluate the efficacy, safety, and feasibility of early EEG-based non-invasive brain-computer interface (EEG-BCI) training as an add-on to standard early rehabilitation in patients with acute ischemic stroke (AIS) after reperfusion therapy. Eligible participants are adults aged 18 to 80 years with unilateral limb motor dysfunction after intravenous thrombolysis (IVT) and\u002For mechanical thrombectomy (MT). Participants will be randomized to receive either standard early rehabilitation plus closed-loop EEG-BCI dual-module virtual hand and gait training, or standard early rehabilitation alone.\n\nThe EEG-BCI intervention includes upper-limb virtual hand training and lower-limb gait\u002Fankle dorsiflexion training, delivered twice daily for approximately 20 minutes per session over 5 consecutive days. The primary outcome is the change in Fugl-Meyer Assessment for Upper Extremity (FMA-UE) score from baseline (T0) to Day 30. Secondary outcomes include upper- and lower-limb motor function, ambulation, neurological status, disability, and activities of daily living. Safety and feasibility outcomes will also be assessed.",[151],"Acute Ischemic Stroke","NOT_YET_RECRUITING","2026-05-08",{"date":155,"type":156},"2026-05-13","ACTUAL",{"date":158,"type":145},"2026-04",{"date":160,"type":145},"2027-06",{"name":5,"class":6}]