[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100618696":3},{"organization":4,"armGroups":7,"interventions":31,"overallOfficials":55,"centralContacts":65,"locations":72,"responsibleParty":106,"collaborators":109,"id":114,"slug":115,"hasResults":116,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":120,"eligibilityCriteria":121,"healthyVolunteers":122,"sex":123,"minAge":124,"maxAge":49,"enrollmentInfo":125,"targetDuration":49,"studyType":128,"phases":129,"briefSummary":131,"conditions":132,"keywords":136,"overallStatus":75,"whyStopped":49,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":149},{"fullName":5,"class":6},"Centre National de la Recherche Scientifique, France","OTHER",[8,15,21,26],{"label":9,"type":10,"description":11,"interventionNames":12},"tDCS+CMT","EXPERIMENTAL","tDCS administered during the performance of cognitive and motor task for 20 min",[13,14],"Procedure: tDCS","Behavioral: Cognitive-Motor Task",{"label":16,"type":10,"description":17,"interventionNames":18},"tSCS+CMT","20-min tSCS administered during the performance of cognitive and motor task for 20 min",[19,20],"Procedure: tSCS","Procedure: Sham",{"label":22,"type":23,"description":24,"interventionNames":25},"tDCS-tSCS+CMT","ACTIVE_COMPARATOR","tDCS associated with tSCS administered during the performance of cognitive and motor task for 20 min",[13,19,14],{"label":27,"type":28,"description":29,"interventionNames":30},"Sham-tDCS-tSCS+CMT","SHAM_COMPARATOR","Sham tDCS associated with Sham tSCS administered during the performance of cognitive and motor task for 20 min",[13,19,20,14],[32,39,45,50],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"PROCEDURE","tDCS","tDCS will be delivered using an electrical stimulation device d (1X1 tES, Soterix Medical Inc., USA, CE marked) delivering a direct current at 2 mA for a period of 20 minutes. Silicone electrodes are placed in sponges soaked in physiological saline (5 cm × 7 cm) (EASYpadTM, Soterix Medical Inc.), with the anode and cathode centered on the optimal cortical areas determined during testing visits.",[27,9,22],[38],"transcranial Direct Current Stimulation",{"type":33,"name":40,"description":41,"armGroupLabels":42,"otherNames":43},"tSCS","tSCS will be applied for 20 minutes using a constant current electrical stimulator (DS5 or DS7A, Digitimer Ltd, CE marked) delivering monophasic pulses at 30 Hz at stimulation sites and intensities specific to each participant and defined in advance during testing visits.",[27,22,16],[44],"transcutaneous Spinal Cord Stimulation",{"type":33,"name":46,"description":47,"armGroupLabels":48,"otherNames":49},"Sham","For the sham stimulation interventions, the current slowly increases to the intensity used during the active interventions for 30 seconds, then slowly decreases over the next 30 seconds, at the beginning and end of the stimulation. The sham interventions use the same electrode placements as during the active ones for a total duration of 20 min.",[27,16],null,{"type":51,"name":52,"description":53,"armGroupLabels":54,"otherNames":49},"BEHAVIORAL","Cognitive-Motor Task","The cognitive-motor task will be administered using the ArmeoControl software supplied with the ArmeoSping® or ArmeoPower® upper limb rehabilitation exoskeleton. Participants will be seated in a chair or their wheelchair and fitted into the exoskeleton.The exoskeleton is linked to a series of exercises performed on a computer via a virtual reality interface (ArmeoControl), which allows simultaneous training of the arms and hands in a large workspace. Two vertical and horizontal \"visually guided reaching\" tasks will be offered, each lasting 10 minutes. These tasks are chosen to provide training in cognitive-motor functions (grabbing a target moving in a virtual workspace) and sensorimotor functions (interacting with the exoskeleton to move the target).",[27,9,22],[56,60,62],{"name":57,"affiliation":58,"role":59},"Fabien Wagner, PhD","Institute of Neurodegenerative Diseases, CNRS UMR 5293","PRINCIPAL_INVESTIGATOR",{"name":61,"affiliation":58,"role":59},"Nabila Brihmat, PhD",{"name":63,"affiliation":64,"role":59},"Hélène Cassoudesalle, MD, PhD","University Hospital, Bordeaux",[66,70],{"name":61,"role":67,"phone":68,"phoneExt":49,"email":69},"CONTACT","+33 5 33 51 48 46","nabila.brihmat@u-bordeaux.fr",{"name":57,"role":67,"phone":68,"phoneExt":49,"email":71},"fabien.wagner@u-bordeaux.fr",[73,91],{"facility":74,"status":75,"city":76,"state":49,"zip":77,"country":78,"countryCode":79,"cosmosGeoPoint":80,"geoPoint":85,"contacts":86},"Service de Médecine Physique & Réadaptation - CHU Bordeaux","RECRUITING","Bordeaux","33000","France","FR",{"type":81,"coordinates":82},"Point",[83,84],-0.58046,44.84124,{"lat":84,"lon":83},[87,90],{"name":63,"role":67,"phone":49,"phoneExt":88,"email":89},"+335679568","secretariat.mpr@chu-bordeaux.fr",{"name":63,"role":59,"phone":49,"phoneExt":49,"email":49},{"facility":92,"status":75,"city":93,"state":49,"zip":94,"country":78,"countryCode":79,"cosmosGeoPoint":95,"geoPoint":99,"contacts":100},"Centre de la Tour de Gassies","Bruges","33520",{"type":81,"coordinates":96},[97,98],-0.61222,44.88287,{"lat":98,"lon":97},[101,105],{"name":102,"role":67,"phone":103,"phoneExt":49,"email":104},"Christophe Roth, MD","+33556163191","gassies.contact@ugecam.assurance-maladie.fr",{"name":102,"role":59,"phone":49,"phoneExt":49,"email":49},{"type":59,"investigatorFullName":107,"investigatorTitle":108,"investigatorAffiliation":5,"oldNameTitle":49,"oldOrganization":49},"Fabien Wagner","Principal investigator",[110,111,113],{"name":64,"class":6},{"name":92,"class":112},"UNKNOWN",{"name":58,"class":112},"100618696","phase-2-synergistic-effect-of-non-invasive-brain-and-spinal-cord-stimulation-100618696",false,"NCT07334977","Synergistic Effect of Non-invasive Brain and Spinal Cord Stimulation","Synergistic Potential of Non-invasive Brain and Spinal Cord Stimulation for Improving Sensorimotor and Cognitive Functions After Neurological Injury","BrainSpineStim","Inclusion Criteria:\n\nCONTROL GROUP:\n\n* Over 18 years of age\n* Participant who has signed an informed consent form\n* Participant who is affiliated with and covered by the social security system\n\nPOST-STROKE GROUP:\n\n* Over 18 years of age\n* Who sustained a stroke more than 3 weeks ago\n* Considered medically stable by the medical investigator\n* Who has signed an informed consent form\n* Affiliated with and covered by the social security system\n\nSCI GROUP:\n\n* Over 18 years of age\n* Considered to have a complete or incomplete spinal cord injury (i.e., with a score on the Spinal Injury Association (ASIA) Impairment Scale (AIS) score from A to D)\n* Considered medically stable by the investigating physician\n* Presenting with quadriplegia due to cervical injury\n* Who has signed an informed consent form\n* Affiliated with and covered by the social security system.\n\nExclusion Criteria:\n\n* Suffering from a chronic condition\n* Skin problems or open wounds\n* History of epilepsy or seizures\n* Presence of a contraindication to the use of magnetic\u002Felectrical stimulation or MRI, including: cardiac pacemaker; implanted hearing aid; intraocular foreign body, shrapnel, or bullets; metal worker; pacemaker or neurostimulator; claustrophobia\n* Presence of implanted medical devices (cardiac valve, endovascular devices, ventricular shunt valve, surgical clips, metallic sutures, staples, stent, osteosynthesis or arthrodesis hardware) not classified as \"MR Conditional\" according to ASTM F2503.\n* Individuals who are legally incompetent, under judicial protection, guardianship, or trusteeship\n* Pregnant and\u002For breastfeeding women\n* Individuals who refuse to be informed of any abnormalities that may be detected by MRI.",true,"ALL","18 Years",{"count":126,"type":127},45,"ESTIMATED","INTERVENTIONAL",[130],"PHASE2","The goal of this clinical study is to investigate the potential synergy between non-invasive brain and spinal cord stimulation administered during a cognitive-motor task, in terms of their immediate effects on sensorimotor and cognitive functions after neurological injuries affecting the upper limb (cervical spinal cord injury and stroke). Secondary objectives are to evaluate the relevance of anatomical MRI, functional MRI, and neurophysiological measurements for optimizing and predicting the effects of these different interventions.",[133,134,135],"Stroke","Spinal Cord Injury","Able Bodied",[137,138,44,38,139],"Neuromodulation","Neuroplasticity","Neuroimaging","2026-01-06",{"date":142,"type":143},"2026-01-12","ACTUAL",{"date":145,"type":143},"2024-12-11",{"date":147,"type":127},"2027-12",{"name":5,"class":6},2]