[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640963":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":44,"responsibleParty":57,"collaborators":26,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":26,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":26,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":84,"whyStopped":26,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"National University Hospital, Singapore","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"iTBS combined with tSCS plus standardized lower limb rehabilitation","EXPERIMENTAL","Interventions are delivered twice weekly for 16 weeks (32 sessions): iTBS over M1 followed by combined tSCS plus lower limb rehabilitation (45-60 min). tSCS uses a constant-current stimulator with 5×10 cm electrodes at placed at one level above and below the site of the spinal cord injury, with reference electrodes over the ASIS or clavicles. Parameters: biphasic pulses at 30 Hz, 1 ms pulses with 10 kHz carrier frequency, intensity 40-120 mA, delivered continuously for \\~45 minutes.The iTBS protocol consists of bursts of 3 pulses at 50 Hz, repeated at 5 Hz (200 ms between bursts), delivered in 2-second trains with 8-second inter-train intervals. Each session will deliver 600 pulses total. The stimulation target will be the leg motor area of the primary motor cortex, identified using established anatomical landmarks and confirmed by eliciting motor evoked potentials (MEPs) in lower extremity muscles. Lower limb rehabilitation follows immediately, supervised by a physiotherapist.",[13,14],"Device: Transcranial Magnetic Stimulation","Device: Transcutaneous Spinal Cord Stimulation",{"label":16,"type":17,"description":18,"interventionNames":19},"tSCS plus standardized lower limb rehabilitation only","ACTIVE_COMPARATOR","tSCS uses a constant-current stimulator with 5×10 cm electrodes at placed at one level above and below the site of the spinal cord injury, with reference electrodes over the ASIS or clavicles. Parameters: biphasic pulses at 30 Hz, 1 ms pulses with 10 kHz carrier frequency, intensity 40-120 mA, delivered continuously for \\~45 minutes. Lower limb rehabilitation follows immediately, supervised by a physiotherapist.",[14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Transcranial Magnetic Stimulation","Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive brain stimulation technique that enhances cortical excitability and corticospinal drive. Intermittent theta burst stimulation (iTBS), a brief patterned form of rTMS, produces lasting facilitatory effects and is more time-efficient. Evidence indicates rTMS improves motor function, reduces spasticity, and enhances neuroplasticity in SCI.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Transcutaneous Spinal Cord Stimulation","Transcutaneous spinal cord stimulation (tSCS) is a non-invasive neuromodulation technique that delivers electrical stimulation over the spine to activate sensory afferents and enhance spinal motor circuit excitability. Early studies showed it can enable voluntary movement even in motor-complete spinal cord injury (SCI), with subsequent research demonstrating improvements in motor function, standing, and walking in incomplete SCI. Evidence suggests tSCS modulates both spinal and corticospinal pathways, supporting neuroplasticity. The Up-LIFT trial (2024) provided strong clinical evidence, showing that tSCS combined with rehabilitation significantly improved upper limb strength and function in chronic cervical SCI, with 72% of participants meeting effectiveness endpoints and no serious adverse events. Later studies confirmed its safety in home and community settings, though standardization and larger trials remain needed.",[9,16],[32],{"name":33,"affiliation":34,"role":35},"Gobinathan Chandran, MBBS","NUH","PRINCIPAL_INVESTIGATOR",[37,41],{"name":33,"role":38,"phone":39,"phoneExt":26,"email":40},"CONTACT","+65 94575924","gobinathan_chandran@nuhs.edu.sg",{"name":42,"role":38,"phone":26,"phoneExt":26,"email":43},"Tang Ning, PhD","ning_tang@nuhs.edu.sg",[45],{"facility":46,"status":26,"city":47,"state":26,"zip":26,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Alexandra Hospital\u002F National University Hospital, Singapore","Singapore","SG",{"type":50,"coordinates":51},"Point",[52,53],103.85007,1.28967,{"lat":53,"lon":52},[56],{"name":33,"role":38,"phone":39,"phoneExt":26,"email":40},{"type":58,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100640963","combined-tms-tscs-for-lower-limb-rehabilitation-in-chronic-incomplete-sci-100640963",false,"NCT07595497","Combined TMS-tSCS for Lower Limb Rehabilitation in Chronic Incomplete SCI","A Randomized Controlled Trial Comparing Combined TMS-tSCS Neuromodulation Versus tSCS Alone Lower Limb Rehabilitation in Chronic Incomplete SCI","Inclusion Criteria\n\n* Age 18-65 years at enrolment\n* Chronic traumatic spinal cord injury, defined as ≥12 months post-injury\n* Incomplete spinal cord injury, AIS grade C or D\n* Neurological level of injury from C2 to L1\n* Baseline Lower Extremity Motor Score (LEMS) \\>10 points\n* Medically stable\n* Able to provide informed consent\n* Able to commit to the full study duration\n* Able to attempt the 10-Meter Walk Test and 6-Minute Walk Test, with or - without assistive devices and standby assistance\n\nExclusion Criteria\n\n* History of seizures or epilepsy\n* Implanted electronic devices, such as: Pacemaker, Cochlear implant, Deep brain stimulator, Spinal cord stimulator, Metallic implants in the head or spine\n* Pregnancy or planned pregnancy\n* Active psychiatric disorder or cognitive impairment\n* Concomitant neurological conditions, such as: Stroke, Traumatic brain injury and Neuropathy\n* Skin breakdown at electrode sites\n* Current participation in another clinical trial\n* History of skull surgery or craniotomy\n* Use of medications that alter cortical excitability within the past 2 weeks","ALL","18 Years","65 Years",{"count":70,"type":71},24,"ESTIMATED","INTERVENTIONAL",[74],"NA","he goal of this clinical trial is to learn if combined brain and spinal cord stimulation using TMS-tSCS can improve leg strength and walking recovery in adults with chronic incomplete spinal cord injury.\n\nThe main questions it aims to answer are:\n\nDoes combined TMS-tSCS improve lower limb motor function more than tSCS alone? Is combined TMS-tSCS safe and does it improve walking speed, independence, muscle activity, spasticity, and nerve pathway function?\n\nResearchers will compare combined TMS-tSCS with tSCS alone with sham TMS to see if adding brain stimulation leads to better recovery than spinal stimulation alone.\n\nParticipants will:\n\nAttend 32 treatment sessions over 16 weeks. Receive either combined TMS-tSCS or tSCS with sham TMS. Undergo assessments of leg strength, walking speed, daily function, muscle stiffness, muscle activity, and nerve pathway function before and after treatment.",[77],"Spinal Cord Injuries (SCI)",[79,80,81,82,23,83],"lower extremity motor score","motor rehabilitation","Neuromodulation","spinal cord injury","transcutaneous spinal cord stimulation","NOT_YET_RECRUITING","2026-05-12",{"date":87,"type":88},"2026-05-19","ACTUAL",{"date":90,"type":71},"2027-01-01",{"date":92,"type":71},"2028-03-01",{"name":5,"class":6},1]