[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100600498":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":41,"responsibleParty":74,"collaborators":76,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":86,"sex":87,"minAge":88,"maxAge":26,"enrollmentInfo":89,"targetDuration":26,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":98,"overallStatus":103,"whyStopped":26,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Fondazione Don Carlo Gnocchi Onlus","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"TMS-FES group","EXPERIMENTAL","Before movement execution, the hand area of the primary motor cortex will be stimulated using active repetitive TMS (rTMS). Subsequently, FES will be applied to assist the subject's voluntary movements during task-oriented therapy.",[13],"Device: TMS and FES- based rehabilitation",{"label":15,"type":16,"description":17,"interventionNames":18},"FES group","ACTIVE_COMPARATOR","Before movement execution, the hand area of the primary motor cortex will be stimulated using sham TMS. Subsequently, FES will be applied to assist the subject's voluntary movements during task-oriented therapy.",[19],"Device: FES-based rehabilitation",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","TMS and FES- based rehabilitation","Each subject will receive 15 individual sessions (45 minutes each, 3 times per week for 5 weeks) of task-based hand and arm exercises.\n\nBefore movement execution, the hand area of the primary motor cortex will be stimulated using active rTMS. The rTMS protocol will use intermittent theta burst stimulation (iTBS), which delivers bursts of 3 pulses at 50 Hz every 200 ms (5 Hz) for 2 seconds, followed by 8 seconds of rest, totaling 600 pulses in \\~3 minutes. The hand area will be identified as the optimal site for eliciting a motor evoked potential (MEP) in the abductor digiti minimi (ADM) muscle, contralateral to the dominant limb, with the lowest possible stimulation intensity.\n\nSubsequently, FES will be applied to assist the subject's voluntary movements during the task-oriented activities. The stimulation will be triggered based on the achievement of the electromyographic (EMG) threshold of the selected muscles.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"FES-based rehabilitation","Each subject will receive 15 individual sessions (45 minutes each, 3 times per week for 5 weeks) of task-based hand and arm exercises.\n\nBefore movement execution, the TMS coil will be positioned over the hand areas of the primary motor cortex, but tilted away from the scalp so as to produce a sound similar to the real intervention, but at a low intensity, without inducing current in the cortex.\n\nFES will then be applied to assist the patient's voluntary movements during the task-oriented activities. The stimulation will be triggered based on the achievement of the electromyographic (EMG) threshold of the selected muscles.",[15],[32],{"name":33,"affiliation":34,"role":35},"Tiziana Lencioni, PhD","IRCCS \"Santa Maria Nascente\" - Fondazione Don Gnocchi","PRINCIPAL_INVESTIGATOR",[37],{"name":33,"role":38,"phone":39,"phoneExt":26,"email":40},"CONTACT","00390240308547","tlencioni@dongnocchi.it",[42,60],{"facility":43,"status":26,"city":44,"state":45,"zip":46,"country":45,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Fondazione Italiana Sclerosi Multipla","Genova","Italy","16149","IT",{"type":49,"coordinates":50},"Point",[51,52],11.87211,45.21604,{"lat":52,"lon":51},[55,59],{"name":56,"role":38,"phone":57,"phoneExt":26,"email":58},"Andrea Tacchino, Professor","00393491403917","andrea.tacchino@aism.it",{"name":56,"role":35,"phone":26,"phoneExt":26,"email":26},{"facility":34,"status":26,"city":61,"state":45,"zip":62,"country":45,"countryCode":47,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"Milan","20148",{"type":49,"coordinates":64},[65,66],9.18951,45.46427,{"lat":66,"lon":65},[69,70,71],{"name":33,"role":38,"phone":39,"phoneExt":26,"email":40},{"name":33,"role":35,"phone":26,"phoneExt":26,"email":26},{"name":72,"role":73,"phone":26,"phoneExt":26,"email":26},"Elena Saretti, Physiatrist","SUB_INVESTIGATOR",{"type":75,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[77],{"name":43,"class":6},"100600498","improving-hand-movement-and-coordination-in-people-with-multiple-sclerosis-using-transcranial-magnetic-stimulation-tms-and-muscle-electrostimulation-fes-to-support-manual-dexterity-and-daily-function-100600498",false,"NCT07098273","Improving Hand Movement and Coordination in People With Multiple Sclerosis Using Transcranial Magnetic Stimulation (TMS) and Muscle Electrostimulation (FES) To Support Manual Dexterity and Daily Function","Restoring Manual Dexterity in Multiple Sclerosis: A Feasibility Study Combining Muscle Electrostimulation and Transcranial Magnetic Stimulation To Enhance Neuroplasticity","MANTRAStim","Inclusion Criteria:\n\n* age \\>18;\n* diagnosis of MS (according to McDonald criteria);\n* stable disease course without a worsening greater than 1 point on the Expanded Disability Status Scale (EDSS) in the past 4 months;\n* right-handed;\n* score on the Box and Block test lower than the normative value adjusted for sex and age +2 standard deviations;\n* score on the cerebellar functional system of the EDSS scale \\\u003C2;\n* ability to provide written informed consent.\n\nExclusion Criteria:\n\n* score on the Mini-Mental State Examination \\\u003C24;\n* Beck Depression Inventory-II \\>19;\n* other neurological or orthopedic conditions that would interfere with upper limb exercises;\n* contraindications to the application of TMS: history of epilepsy or non-febrile seizures; presence of metallic or electronic implants in the cranial or cervical region; presence of pacemakers or implantable defibrillators; severe uncontrolled psychiatric disorders (e.g., psychosis, mania); current or suspected pregnancy;\n* contraindications to the application of FES: skin integrity issues at the site of electrode placement; implanted electronic devices.",true,"ALL","18 Years",{"count":90,"type":91},50,"ESTIMATED","INTERVENTIONAL",[94],"NA","The goal of this interventional study is to test whether combining transcranial magnetic stimulation (TMS) with functional electrical stimulation (FES) can improve hand and upper limb function in adults with Multiple Sclerosis (MS).\n\nThe clinical trial aims to determine the following points:\n\n1. Whether TMS combined with FES produces greater effects compared to FES alone.\n2. Changes in brain and muscle activity related to hand function after treatment.\n3. Specific clinical or neurophysiological factors that predict who will benefit most from the intervention. Researchers will compare the TMS-FES group (receiving brain magnetic stimulation and muscle electrostimulation) with the FES group (receiving only muscle electrostimulation) to assess whether TMS provides additional benefits in improving upper limb function\n\nParticipants will:\n\n* Be assigned to a group (TMS-FES group or FES group)\n* Attend 15 sessions (45 minutes each, 3 times per week for 5 weeks) of task-based hand and arm exercises, during which FES, or TMS and FES, will be administered to the participant.\n* Undergo assessments before, after, and 3 months after training to measure hand function, brain and muscle responses, fatigue, and daily activity performance.",[97],"Multiple Sclerosis",[97,99,100,101,102],"Hand Dexterity","Technology-based Rehabilitation","Functional Electrical Stimulation","Transcranial Magnetic Stimulation","NOT_YET_RECRUITING","2025-08-06",{"date":106,"type":107},"2025-08-12","ACTUAL",{"date":109,"type":91},"2025-10",{"date":111,"type":91},"2027-05",{"name":5,"class":6},2]