[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100588379":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":36,"responsibleParty":55,"collaborators":57,"id":62,"slug":20,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":63,"sex":69,"minAge":70,"maxAge":20,"enrollmentInfo":71,"targetDuration":20,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":81,"overallStatus":39,"whyStopped":20,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"VASCage GmbH","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"All participants","EXPERIMENTAL","25 BCI-FES therapy sessions over 13 weeks",[13],"Device: closed-loop BCI-FES device",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","closed-loop BCI-FES device","Closed-loop neurorehabilitation system that combines EEG-based brain-computer interface technology with functional electrical stimulation (FES) to facilitate neural and motor recovery.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Michael Knoflach, Assoc.-Prof.","Medical University Innsbruck","PRINCIPAL_INVESTIGATOR",[27,32],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Simon Sollereder, MSc","CONTACT","+43 664 1004838","simon.sollereder@vascage.at",{"name":33,"role":29,"phone":34,"phoneExt":20,"email":35},"Petr Simurda, MD","+43 512 554 43513","petr.simurda@vascage.at",[37],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Department for Neurology, Medical University of Innsbruck","RECRUITING","Innsbruck","Tyrol","6020","Austria",{"type":45,"coordinates":46},"Point",[47,48],11.39454,47.26266,{"lat":48,"lon":47},[51,54],{"name":23,"role":29,"phone":52,"phoneExt":20,"email":53},"+43 512 504 81697","michael.knoflach@i-med.ac.at",{"name":23,"role":25,"phone":20,"phoneExt":20,"email":20},{"type":56,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[58,61],{"name":59,"class":60},"g.tec medical engineering GmbH","INDUSTRY",{"name":24,"class":6},"100588379",false,"NCT06940635","Exploratory Study on the Potential Cross-System Effects of BCI-FES Hand Therapy on Dysphagia and Aphasia in Chronic Stroke Patients","Cross-Stroke Therapy Effects With BCI and FES Stimulation: A Pilot Study","c-STEPS","Inclusion Criteria:\n\n* Age: Participants must be aged 18 years or older.\n* Post-Stroke Phase: Participants must be within the chronic post-stroke phase (time since ischemic or haemorrhagic stroke greater than 3 months).\n* Motor Impairment: Participants must exhibit disabling left or right residual arm paresis (\"left\u002Fright arm motor drift\" part of the NIHSS score ≥1).\n* Speech\u002FSwallowing Impairment: Participants must have:\n\n  * Aphasia (AAT-Skala zum Kommunikationsverhalten score ≤3), and\u002For\n  * Dysphagia (MUCCS-N score ≥2).\n* Stable Neurological Status: No relevant changes in neurological status in the past 4 weeks (self-reported).\n* Motor Function: Participants must be able to raise at least 1 block similar to the ones in Box-and-Block-Test.\n* Cognitive Understanding: Participants must be able to understand basic spoken instructions.\n* Sitting Tolerance: Participants must be able to maintain a sitting position for at least 60 minutes.\n* Willingness to Participate: Participants must be willing to participate in the study and able to understand and sign the informed consent.\n\nExclusion Criteria:\n\n* Cognitive Impairments: Cognitive impairments that, in the investigator's judgment, could limit understanding of task instructions.\n* Stroke Location: Participants with a brainstem and\u002For cerebellar stroke.\n* Previous Stroke: Participants with a previous disabling stroke.\n* Hemi-Neglect: Pronounced hemi-neglect at the last documented therapy visit that limits compliance with treatment intervention (investigator's judgment).\n* Anosognosia: Pronounced anosognosia at the last documented therapy visit that limits compliance with treatment intervention (investigator's judgment).\n* Spasticity: Severe spasticity in the affected limb, resulting in complete rigidity in flexion or extension.\n* Seizure Disorders: Participants with uncontrolled epilepsy (investigator's judgement) or epileptic seizure within the last month.\n* Intracranial Pressure: Known ongoing elevated intracranial pressure.\n* Implanted Medical Devices: Participants with implanted medical devices with contraindication for FES such as pacemakers.\n* Metallic Fragments: Participants with implanted metallic fragments in the extremity planned for FES that would limit the use of functional electrical stimulation (FES).\n* Unhealed Injuries: Unrecovered fractures or skin\u002Ftissue lesions in the FES stimulated extremity.\n* Joint Issues: Ossification, contraction, or stiffness of the wrist joint in the FES stimulated extremity that would limit treatment.\n* Botulinum Toxin: Participants who received botulinum-toxin treatment within 6 weeks prior to study inclusion and\u002For for whom botulinum-toxin treatment is planned during the study duration.\n* Co-morbidities: The following conditions will exclude participation:\n\n  * Chronic Obstructive Pulmonary Disease (Stage IV).\n  * Cardiac insufficiency (NYHA Stage IV).\n  * Severe acute infections.\n  * Significant circulatory disturbances in the stimulated extremity.\n  * Sensory disorders that significantly impair the patient's ability to feel pain or react to unsuitable proprioceptive stimuli.\n  * Any other general medical conditions that, in the investigator's judgment, limit the safety or performance of study procedures (investigator's judgement).\n* Electrical Stimulation Intolerance: Known inability to tolerate cutaneous electrical stimulation.","ALL","18 Years",{"count":72,"type":73},10,"ESTIMATED","INTERVENTIONAL",[76],"NA","The goal of this neurorehabilitation explorative study is to investigate how a closed-loop Brain-Computer Interface Functional Electrical Stimulation (BCI-FES) therapy, used within the intended purpose for hand rehabilitation, may impact swallowing difficulties (dysphagia) and language disorders (aphasia) in post-stroke patients.",[79,80],"Ischaemic Stroke","Hemorrhagic Stroke",[82,83,84,85,86],"neurorehabilitation","BCI-FES","chronic stroke","aphasia","dysphagia","2025-11-25",{"date":89,"type":90},"2025-11-26","ACTUAL",{"date":92,"type":90},"2025-06-04",{"date":94,"type":73},"2026-06-30",{"name":5,"class":6},1]