[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100604640":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":42,"studyPopulation":33,"armGroups":43,"interventions":57,"overallOfficials":33,"centralContacts":33,"locations":72,"responsibleParty":99,"collaborators":33,"id":102,"slug":33,"hasResults":103,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":103,"sex":109,"minAge":110,"maxAge":111,"enrollmentInfo":112,"targetDuration":33,"studyType":115,"phases":116,"briefSummary":118,"conditions":119,"keywords":121,"overallStatus":126,"whyStopped":33,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":136},{"fullName":5,"class":6},"Parc de Salut Mar","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":33},[9],{"measure":10,"description":11,"timeFrame":12},"Change in Upper Limb Function (9-Hole Peg Test)","The 9-Hole Peg Test (9HPT) is a validated quantitative measure of upper extremity function. Participants are timed while placing and removing nine pegs into holes on a board as quickly as possible. Performance is recorded as time to completion. Change from baseline will be compared between active and sham groups.","Baseline and Week 12",[14,17,20,23,26,29],{"measure":15,"description":16,"timeFrame":12},"Change in Hand Grip Strength (Dynamometry)","Grip strength will be measured using a calibrated hand dynamometer. The mean of three trials per hand will be recorded and analyzed as change from baseline.",{"measure":18,"description":19,"timeFrame":12},"Change in Quality of Life (EQ-5D-5L)","Patient-reported outcome measuring five domains of health-related quality of life (mobility, self-care, usual activities, pain\u002Fdiscomfort, and anxiety\u002Fdepression). Change from baseline will be assessed.",{"measure":21,"description":22,"timeFrame":12},"Change in Fatigue (Modified Fatigue Impact Scale - MFIS)","Self-reported questionnaire measuring the impact of fatigue on physical, cognitive, and psychosocial functioning. Change from baseline will be analyzed.",{"measure":24,"description":25,"timeFrame":12},"Change in Manual Dexterity (Box and Block Test)","The Box and Block Test measures gross manual dexterity by counting the number of blocks moved from one compartment to another in 60 seconds. Change from baseline will be assessed",{"measure":27,"description":28,"timeFrame":12},"Patient-Reported Upper Limb Function (Multiple Sclerosis Impact Scale - MSIS-29, upper limb subitems)","Patient-reported outcome measure assessing the perceived impact of MS on physical function, with specific focus on upper limb-related items. Higher scores indicate greater impact. Change from baseline will be compared.",{"measure":30,"description":31,"timeFrame":32},"Safety and Tolerability","Number and severity of adverse events related to the device or therapy will be recorded throughout the study. Tolerability will be assessed via patient-reported discomfort during stimulation.","Baseline through Week 12",null,{"allocation":35,"interventionModel":36,"interventionModelDescription":33,"primaryPurpose":6,"observationalModel":33,"timePerspective":33,"maskingInfo":37},"RANDOMIZED","PARALLEL",{"masking":38,"maskingDescription":33,"whoMasked":39},"DOUBLE",[40,41],"PARTICIPANT","INVESTIGATOR","This is a pilot, randomized, placebo-controlled study designed to evaluate the efficacy and safety of transcutaneous spinal cord stimulation (tSCS) in improving upper limb function in patients with Multiple Sclerosis (MS).\n\ntSCS is a non-invasive neuromodulation technique that delivers low-intensity electrical impulses through the skin to specific spinal segments. This external stimulation aims to enhance spinal excitability and restore communication between the brain and spinal circuits affected by MS. Previous research in spinal cord injury has demonstrated functional improvements in motor performance with tSCS, suggesting its potential benefit in MS-related disability.\n\nIn this study, participants with clinically confirmed MS and upper limb impairment will first undergo a 6-week period of standard occupational therapy. After this run-in phase, they will be randomly assigned in a 1:1 ratio to receive either active tSCS or sham stimulation for an additional 6 weeks, while continuing occupational therapy. The intervention will be delivered at the rehabilitation center of Hospital de la Esperanza, in a seated position, using surface electrodes placed at the posterior cervical region. Sessions will last approximately 30 minutes, three times per week (preferably Monday, Wednesday, and Friday).\n\nThe sham condition will mimic the procedure using the same equipment and electrode placement but without delivering effective stimulation. After completion of the blinded phase, participants originally randomized to sham will be offered the opportunity to receive active tSCS in an open-label extension.\n\nThe primary efficacy endpoint is improvement in upper limb function, assessed by the Nine-Hole Peg Test (9HPT). Secondary endpoints include the Action Research Arm Test (ARAT), patient-reported outcomes (NeuroQOL - Upper Extremity Function, Modified Fatigue Impact Scale \\[MFIS\\], and Global Impression of Change \\[GIC\\]), and clinical safety measures.\n\ntSCS is generally safe and well-tolerated. Reported side effects are typically mild and transient, including tingling, skin irritation, or muscle discomfort. Participants will be monitored throughout the study, and adverse events will be recorded.\n\nThis pilot trial will provide preliminary data on the clinical utility of tSCS in MS and inform the design of larger randomized controlled trials.",[44,51],{"label":45,"type":46,"description":47,"interventionNames":48},"Active tSCS + Rehabilitation","EXPERIMENTAL","Participants will receive active transcutaneous spinal cord stimulation (tSCS) using the SCONE™ device, combined with conventional upper limb rehabilitation therapy.",[49,50],"Device: Active stimulation tSCS","Behavioral: Occupational\u002FUpper Limb Rehabilitation Therapy",{"label":52,"type":53,"description":54,"interventionNames":55},"Sham tSCS + Rehabilitation","SHAM_COMPARATOR","Participants will receive sham stimulation using the SCONE™ device without active current, combined with conventional upper limb rehabilitation therapy. The setup will be identical to the active intervention to maintain blinding.",[56,50],"Device: Sham: stimulations using a non-active electric stimulation",[58,63,67],{"type":59,"name":60,"description":61,"armGroupLabels":62,"otherNames":33},"DEVICE","Active stimulation tSCS","Active transcutaneous spinal cord stimulation (tSCS) delivered with the SCONE™ device. Electrical currents are applied non-invasively through surface electrodes placed on the skin over the spine. Sessions are combined with standardized upper limb rehabilitation therapy. Participants receive stimulation twice per week for 12 weeks.",[45],{"type":59,"name":64,"description":65,"armGroupLabels":66,"otherNames":33},"Sham: stimulations using a non-active electric stimulation","Sham stimulation delivered with the SCONE™ device, using identical setup and procedures as the active intervention but without effective current. This procedure is designed to mimic the sensation and experience of active stimulation while delivering no therapeutic neuromodulation. Participants also perform standardized upper limb rehabilitation therapy twice per week for 12 weeks.Transcutaneous Spinal Cord Stimulation (tSCS) - Sham (SCONE™)",[52],{"type":68,"name":69,"description":70,"armGroupLabels":71,"otherNames":33},"BEHAVIORAL","Occupational\u002FUpper Limb Rehabilitation Therapy","Standardized occupational therapy program focused on upper limb function. Sessions are delivered in combination with either active or sham transcutaneous spinal cord stimulation.",[45,52],[73],{"facility":74,"status":33,"city":75,"state":33,"zip":76,"country":77,"countryCode":78,"cosmosGeoPoint":79,"geoPoint":84,"contacts":85},"Hospital del Mar","Barcelona","08003","Spain","ES",{"type":80,"coordinates":81},"Point",[82,83],2.15899,41.38879,{"lat":83,"lon":82},[86,91,95,97],{"name":87,"role":88,"phone":89,"phoneExt":33,"email":90},"Pablo Villoslada, MD, PhD","CONTACT","+34933160455","pvilloslada@researchmar.net",{"name":92,"role":88,"phone":33,"phoneExt":93,"email":94},"Silvia Susin, MD","1438","ssusin@researchmar.net",{"name":87,"role":96,"phone":33,"phoneExt":33,"email":33},"PRINCIPAL_INVESTIGATOR",{"name":92,"role":98,"phone":33,"phoneExt":33,"email":33},"SUB_INVESTIGATOR",{"type":96,"investigatorFullName":100,"investigatorTitle":101,"investigatorAffiliation":5,"oldNameTitle":33,"oldOrganization":33},"PAblo Villoslada","Principal Investigator, Neurology Department, Hospital del Mar Research Institute","100604640",false,"NCT07152145","Pilot Study of tSCS for Improving Upper Limb Function in People With Multiple Sclerosis","Transcutaneous Electrical Spinal Stimulation (tSCS) for Improving Upper Limb Function in People With MS","tSCS-MS","Inclusion Criteria:\n\n* Age between 18 and 70 years.\n* Diagnosis of Multiple Sclerosis (according to revised McDonald criteria).\n* Upper limb dysfunction (9-Hole Peg Test score ≥ 20% slower than normative values).\n* Stable disease-modifying treatment for ≥ 6 months before enrollment.\n* Expanded Disability Status Scale (EDSS) score between 3.0 and 6.5.\n* Ability to provide informed consent.\n\nExclusion Criteria:\n\n* Relapse or corticosteroid treatment within the last 3 months.\n* Severe spasticity of the upper limb (Modified Ashworth Scale \\> 3).\n* Implanted electrical devices (pacemaker, spinal cord stimulator).\n* Epilepsy or uncontrolled seizures.\n* Severe psychiatric disorders or cognitive impairment interfering with study procedures.\n* Pregnant or breastfeeding women.\n* Participation in another interventional clinical trial within the last 3 months.","ALL","18 Years","70 Years",{"count":113,"type":114},60,"ESTIMATED","INTERVENTIONAL",[117],"NA","The goal of this clinical trial is to evaluate whether non-invasive spinal cord neuromodulation with the SCONE™ device can improve upper limb function in people with multiple sclerosis. The study will investigate if combining SCONE™ therapy with rehabilitation exercises leads to improvements in arm and hand movement, and whether the therapy is safe and well tolerated in this patient population. Participants will receive non-invasive spinal cord stimulation with the SCONE™ device and perform rehabilitation exercises specifically focused on the upper limb.",[120],"Multiple Sclerosis",[122,123,124,125],"Spinal Cord Neuromodulation","Non-invasive neuromodulation","Upper limb function","Neurorehabilitation","NOT_YET_RECRUITING","2025-08-28",{"date":129,"type":130},"2025-09-03","ACTUAL",{"date":132,"type":114},"2025-10",{"date":134,"type":114},"2026-12",{"name":5,"class":6},1]