[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100620746":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":38,"locations":50,"responsibleParty":75,"collaborators":53,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":79,"sex":85,"minAge":86,"maxAge":53,"enrollmentInfo":87,"targetDuration":53,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":98,"overallStatus":113,"whyStopped":53,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Activity-based therapy with sham spinal stimulation (n=20)","SHAM_COMPARATOR","Participants with cervical spinal cord injury (ASIA levels A-D) randomized to this arm will receive sham transcutaneous spinal cord stimulation combined with activity-based therapy. Training will consist of 20 sessions delivered over 6-8 weeks during the subacute stage.\n\nFor the transcutaneous spinal cord stimulation (tSCS), a single or two self-adhesive cathode electrodes will be placed at the C4 to T1 vertebral levels. A pair of reference electrodes will be placed bilaterally on the external part of the clavicular regions. The stimulation will be set at minimal intensity, sufficient only for the participants to perceive it.",[13],"Other: Protocol 1: Combination of activity-based therapy and sham spinal cord stimulation",{"label":15,"type":16,"description":17,"interventionNames":18},"Activity-based therapy with facilitatory spinal stimulation (n=20)","EXPERIMENTAL","Participants with cervical spinal cord injury (ASIA levels A-D) randomized to this arm will receive real-intensity transcutaneous spinal cord stimulation combined with activity-based therapy. Training will consist of 20 sessions delivered over 6-8 weeks during the subacute stage.\n\nFor the transcutaneous spinal cord stimulation (tSCS), a single or two self-adhesive cathode electrodes will be placed at the C4 to T1 vertebral levels. A pair of reference electrodes will be placed bilaterally on the external part of the clavicular regions. The stimulation will be set at minimal intensity, sufficient only for the participants to perceive it. Individualized tSCS parameters (30-80Hz, 0-90mA, biphasic 400us pulse square) will be used to facilitate upper limb movement.",[19],"Other: Protocol 2: Combination of activity-based therapy and facilitatory transcutaneous spinal cord stimulation",[21,27],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Protocol 1: Combination of activity-based therapy and sham spinal cord stimulation","The training session for the sham group comprises of activity-based therapy along with sham stimulation on the spinal cord of the participants. These training sessions will include repetitive, intensive strength training and functional exercises targeting arm and hand (upper limb) movements. Sessions will be delivered by trained physiotherapists and occupational therapists. Each participant will complete 20 sessions over six to eight weeks (three per week), with each session lasting 45 minutes. Breaks will be added, if needed. Training will begin with a mental imagery exercise in which participants imagine performing a daily activity (e.g., drinking coffee in a café), followed by therapist-selected activities. Participants will receive transcutaneous spinal cord stimulation set at sensory threshold intensity (i.e., below the threshold that facilitates voluntary movement of the limb; usually 2-3 mA intensity), delivered simultaneously with training.",[9],[26],"Sham stimulation",{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Protocol 2: Combination of activity-based therapy and facilitatory transcutaneous spinal cord stimulation","The training session for the experimental group comprises of activity-based therapy along with facilitatory stimulation on the spinal cord of the participants. These training sessions will include repetitive, intensive strength training and functional exercises targeting arm and hand (upper limb) movements. Sessions will be delivered by trained physiotherapists and occupational therapists. Each participant will complete 20 sessions over six to eight weeks (three per week), with each session lasting 45 minutes. Breaks will be added, if needed. Training will begin with a mental imagery exercise in which participants imagine performing a daily activity (e.g., drinking coffee in a café), followed by therapist-selected activities. Participants will receive transcutaneous spinal cord stimulation set at a target intensity that facilitates voluntary upper limb movement (usually between 10 and 25 mA) in the participants.",[15],[32],"tSCS",[34],{"name":35,"affiliation":36,"role":37},"Dorothy Barthelemy, pht., PhD","Université de Montréal","PRINCIPAL_INVESTIGATOR",[39,45],{"name":40,"role":41,"phone":42,"phoneExt":43,"email":44},"Dorothy Barthelemy, pht., Ph.D","CONTACT","+1 514-343-6111","13962","dorothy.barthelemy@umontreal.ca",{"name":46,"role":41,"phone":47,"phoneExt":48,"email":49},"Marika Demers, erg., Ph.D","514-343-6111","30897","marika.demers@umontreal.ca",[51],{"facility":52,"status":53,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"Institut de réadaptation Gingras-Lindsay-de-Montréal (IRGLM)",null,"Montreal","Quebec","H3S 2J4","Canada","CA",{"type":60,"coordinates":61},"Point",[62,63],-73.58781,45.50884,{"lat":63,"lon":62},[66,69,73,74],{"name":67,"role":41,"phone":68,"phoneExt":53,"email":44},"Dorothy Barthelemy, pht, PhD","514-343-7712",{"name":70,"role":41,"phone":71,"phoneExt":53,"email":72},"Sujata Sinha, M.Tech., Ph.D","514-605-2320","sujata.sinha@umontreal.ca",{"name":35,"role":37,"phone":53,"phoneExt":53,"email":53},{"name":46,"role":37,"phone":53,"phoneExt":53,"email":53},{"type":76,"investigatorFullName":53,"investigatorTitle":53,"investigatorAffiliation":53,"oldNameTitle":53,"oldOrganization":53},"SPONSOR","100620746","upper-limb-rehabilitation-using-non-invasive-spinal-cord-stimulation-100620746",false,"NCT07361627","Upper Limb Rehabilitation Using Non-invasive Spinal Cord Stimulation","Improving Upper Limb Motor Control With Spinal Stimulation","CIME_upperlimb","Inclusion Criteria:\n\n* quadraplegic participants with a subacute spinal cord injury (sSCI), defined as the stage of spinal cord damage occurring between 1 week and 6 months post-injury, that fall within the period of at least one year post-injury\n* 16 years old or above\n* have a lesion between above T2\n* residual upper limb movement\n* have injury level according to ASIA A to D\n* hospitalized in the hospital linked with the research center at Gingras Lindsay Rehabilitation Institute of Montreal, 6300 Darlington, Montreal\n* can provide informed consent (no severe cognitive deficits by MoCA)\n* be able to follow instructions in French or English\n\nExclusion Criteria:\n\n* have a pacemaker\n* have active cancer on stimulation site or metastatic cancer\n* have unstable health conditions\n* have unhealed wound, scar or pain which makes positioning of the electrodes impossible\n* participants with specific contraindications to TMS (epilepsy, non-union cranial fracture and increased intracranial pressure) will be able to participate in the study, but will not receive TMS","ALL","16 Years",{"count":88,"type":89},40,"ESTIMATED","INTERVENTIONAL",[92],"NA","The goal of this RCT study is to evaluate if combining activity-based therapy (ABT) with transcutaneous spinal cord stimulation (tSCS) can improve recovery of arm and hand movement in people with cervical spinal cord injury (SCI). As secondary aims, the study will also investigate at how this combination approach affects the cortical changes in the somatosensory and motor areas of the brain, as well as in the spinal cord and whether it helps participants use their arms more in daily life.\n\nThe main questions relevant to this study are:\n\n1. Can the combination of ABT + tSCS improve motor and sensory functions of the arms and hands more than ABT alone during the sub-acute stage after SCI?\n2. Does ABT + tSCS induce neuroplasticity, that is, changes in the brain and spinal cord activity linked to motor and sensory functions?\n3. Do participants who receive ABT + tSCS report greater use of their arms in daily activities compared to those who receive ABT only?\n\nIn this study, participants will:\n\n* Receive either ABT + tSCS or ABT + sham stimulation (a low-intensity current that does not facilitate the movements)\n* Take part in 20 training sessions over 6-8 weeks (3 times per week, 45 min of active training each). During this, they will perform strengthening, task-based training, and mental imagery exercises with a therapist.\n* Complete clinical tests and neurophysiological assessments (transspinal electrical stimulation, electroencephalography and transcranial magnetic stimulation) at three time points-- at the start, after training, and one month later to measure recovery and brain activity changes.\n\nResearchers will compare the assessment outcomes across the three time points.",[95,96,97],"Spinal Cord Injury Cervical","Spinal Cord Injury, Acute","Spinal Cord Injury (Quadraplegia)",[99,100,101,102,103,104,105,106,107,108,109,110,111,112],"Spinal cord injury","Sub-acute","Neuromodulation","transcutaneous Spinal Cord Stimulation","Activity-based therapy","Upper extremity motor score","Rehabilitation","Electroencephalography","EEG","Somatosensory evoked potential","Transcranial Magnetic Stimulation","Motor evoked potential","Clinical assessment","Neuroplasticity","NOT_YET_RECRUITING","2026-02-27",{"date":116,"type":117},"2026-03-02","ACTUAL",{"date":119,"type":89},"2026-04-01",{"date":121,"type":89},"2028-08-09",{"name":5,"class":6},1]