[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100525069":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":37,"centralContacts":51,"locations":61,"responsibleParty":76,"collaborators":78,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":75,"eligibilityCriteria":87,"healthyVolunteers":83,"sex":88,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":75,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":100,"overallStatus":63,"whyStopped":75,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"Max Planck Institute for Human Cognitive and Brain Sciences","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Active stimulation - Placebo stimulation","EXPERIMENTAL","Participants will undergo a 2 intervention periods. The first intervention period will consist of a 2-week course of rTMS followed by BCI-mediated training. This intervention will be succeeded by a 4-week washout period to mitigate any carry-over effects. The second intervention period will entail 2 weeks of sham rTMS followed by BCI-mediated training.",[13,14],"Device: Active rTMS","Device: Sham rTMS",{"label":16,"type":10,"description":17,"interventionNames":18},"Placebo stimulation - Active stimulation","Participants will undergo the same interventions as the first arm but delivered in inverse order. The first intervention period will consist of 2 weeks of sham rTMS followed by BCI-mediated training. The second intervention period will entail 2 weeks of rTMS prior to BCI-mediated training and will start after a 4-weeks washout period.",[13,14],[20,29],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Active rTMS","The Transcranial Magnetic Stimulation will consist of placing a figure-of-eight shape coil of wire over the head of the participants. Then, a brief electric current will pass through the coil, inducing a magnetic field capable of stimulating neurons located beneath the coil. For the active coil, the maximal stimulation intensity is reached beneath the center of the coil.\n\nIn the present study, the intermittent theta-burst protocol will be implemented. This protocol is expected to modulate the excitability of the brain, priming it for a stronger activation of the motor-related brain areas engaged during brain-computer interface-based training. The structural MRI of each participant will be used to guide neuronavigation towards ipsilesional motor areas.",[9,16],[26,27,28],"Intermittent Theta Burst Stimulation","Repetitive Transcranial Magnetic Stimulation","iTBS",{"type":21,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Sham rTMS","To implement a placebo stimulation, a sham coil will be used to deliver the same stimulation protocol. The sham coil is identical in dimensions and weight to the active coil but produces a diminished magnetic field. For the sham coil, the stimulation intensity is minimal beneath the center of the coil, the same area with the highest intensity during stimulation with an active coil. The structural MRI scan of each participant will be used to guide neuronavigation towards the same area where the active stimulation was applied.",[9,16],[34,35,36],"Placebo Intermittent Theta Burst Stimulation","Placebo Repetitive Transcranial Magnetic Stimulation","Sham iTBS",[38,42,45,49],{"name":39,"affiliation":40,"role":41},"Aimee Flores-Sandoval, MsC","Charité Universitätmedizin Berlin and Max Planck Institute for Human Cognitive and Brain Sciences","STUDY_CHAIR",{"name":43,"affiliation":5,"role":44},"Arno Villringer, MD PhD","STUDY_DIRECTOR",{"name":46,"affiliation":47,"role":48},"Bernhard Sehm, PD. med.","Max Planck Institute for Human Cognitive and Brain Sciences and Halle University","PRINCIPAL_INVESTIGATOR",{"name":50,"affiliation":5,"role":48},"Vadim Nikulin, PhD.",[52,58],{"name":53,"role":54,"phone":55,"phoneExt":56,"email":57},"Aimee Arely Flores Sandoval, MsC","CONTACT","+49 341 9940","2256","flores@cbs.mpg.de",{"name":43,"role":54,"phone":55,"phoneExt":59,"email":60},"2220","villringer@cbs.mpg.de",[62],{"facility":5,"status":63,"city":64,"state":65,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"RECRUITING","Leipzig","Saxony","04103","Germany","DE",{"type":70,"coordinates":71},"Point",[72,73],12.37129,51.33962,{"lat":73,"lon":72},null,{"type":77,"investigatorFullName":75,"investigatorTitle":75,"investigatorAffiliation":75,"oldNameTitle":75,"oldOrganization":75},"SPONSOR",[79],{"name":80,"class":6},"University of Halle Medical Faculty","100525069","magnetic-brain-stimulation-and-computer-based-motor-training-for-rehabilitation-after-stroke-100525069",false,"NCT06116942","Magnetic Brain Stimulation and Computer-based Motor Training for Rehabilitation After Stroke","Repetitive Transcranial Magnetic Stimulation for Enhancing Brain Computer Interphase-induced Plasticity in Stroke: a Crossover Design","Inclusion Criteria:\n\n1. Diagnosis of a subcortical stroke at least 6 months before the initiation of the trial and confirmed with magnetic resonance imaging (MRI) or computed tomography\n2. Present moderate to severe hemiparesis in an upper limb\n3. Language comprehension as well as visual and auditory perception sufficient to engage in Brain Computer Interface training\n4. Age from 20 to 80 years old\n5. Clear consciousness and stable vital signs\n6. Eligible for MRI, EEG, BCI and TMS methods\n\nExclusion Criteria:\n\n1. Drug abuse or recent changes in medications that may alter the central nervous system when the measurements begin or during the measurements (e.g., benzodiazepines, serotoninergic and dopaminergic agents)\n2. History of seizure\n3. Bone, joint and muscle diseases\n4. Peripheral neuropathy or other neurological or psychiatric diseases (including, tinnitus, migraine, or mood disorders with the exception of minimal, mild, and moderate depression, reflected as a Beck depression scale score lower than 29).\n5. Strong cognitive deficits (including speech, attention, hearing, vision, sensation or intelligence deficits) reflected as a Montreal Cognitive Assessment (MoCA) score lower or equal to 24\n6. Lesions in the upper extremities\n7. Bone, joint and muscle diseases\n8. Severe spasticity (higher than 3) or pain in the upper limb and affecting wrist extension\n9. Contraindications of undergoing TMS examinations: history of seizures, history of epilepsy, unclear unconsciousness, migraines or metals on the head\n10. Contraindications for MRI: metals in the body, metallic prosthetics or claustrophobia\n11. Participation in other interventional trials using BCI or rTMS within less than 6 months ago\n12. Participation in another interventional clinical trial\n13. Suspected lack of compliance\n14. Pregnant or nursing women","ALL","20 Years","80 Years",{"count":92,"type":93},24,"ESTIMATED","INTERVENTIONAL",[96],"NA","The goal of the present clinical trial is to explore whether an innovative technology-based approach can help individuals who have had a stroke and can no longer move their hands with ease. Our approach consists of a combination of two technologies: Transcranial Magnetic Stimulation (TMS) and a Brain-Computer Interface (BCI). The former entails the application of magnetic fields over the head to stimulate the brain preparing it for a better ability to produce movement. The latter consists of measuring brain activity to personalize a type of computer-based training that is designed to increase communication between the brain and the muscles.",[99],"Chronic Stroke",[101,26,102,103,104,105,106,107,108,109],"Transcranial Magnetic Stimulation","Brain-Computer Interface","Rehabilitation","EEG","MRI","Molecular changes","Brain plasticity","Stroke","Hemiparesis","2023-11-08",{"date":112,"type":113},"2023-11-09","ACTUAL",{"date":110,"type":93},{"date":116,"type":93},"2027-09-19",{"name":5,"class":6},1]