[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100575515":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":37,"centralContacts":41,"locations":50,"responsibleParty":74,"collaborators":29,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":29,"eligibilityCriteria":84,"healthyVolunteers":80,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":29,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":97,"overallStatus":52,"whyStopped":29,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Kessler Foundation","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Active Spinal Cord Transcutaneous Stimulation Combined with Activity-based Training","ACTIVE_COMPARATOR","Participants will receive activity-based training (ABT) while receiving concomitant, active spinal stimulation (scTS) applied at the cervical and thoracic spinal segments over the dorsal skin with optimized and customized stimulation parameters. Round self-adhesive electrodes will be placed over the skin at the midline of spinous processes as cathodes and a pair of rectangular anodes electrodes will be placed over the anterior iliac crests of the pelvis. The stimulation waveform is rectangular pulse with 1-ms duration filled with a carrier frequency of 5kHz. Target simulation will be sub-threshold for UE muscle activation and verified by the absence of visible muscle contraction. The stimulation parameters will be adjusted as needed throughout the intervention course based on the participant's performance and comfort level. The intervention will be administered over 2 consecutive weeks, for 30mins\u002Fsession and 5 sessions\u002Fweek, as a part of their daily 3-hour therapy.",[13],"Other: Active Stimulation",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham Spinal Cord Transcutaneous Stimulation Combined with Activity-based Training","SHAM_COMPARATOR","The sham-control group will go through ABT paired with sham stimulation to control for placebo effects associated with the perception of scTS. Stimulation will be delivered at one cervical location. No stimulation mapping procedure will be performed. During the training session, the stimulation intensity will be briefly ramped up to a level at which the participants report perceiving the stimulation, and then ramped down to 0mA at both the start and the end of session. The stimulator and electrodes will remain attached to the participant while receiving ABT training. The intervention will be administered over 2 consecutive weeks, for 30mins\u002Fsession and 5 sessions\u002Fweek, as a part of their daily 3-hour therapy.",[19],"Other: Sham",{"label":21,"type":6,"description":22,"interventionNames":23},"Activity-based Training Only","Participants in ABT group will receive ABT only. ABT will concentrate on activities of gross UE movement, grasping, pinching, gross and fine motor skill. The hand grasp task will focus on grasping objects with different shapes and weights (i.e. weighted container and tennis ball) and placing\u002Fremoving them from small storage container; the pinch task involves picking up, translating, and releasing small objects with varied sizes (i.e. blocks, dices, marble balls, nuts, etc.). The training therapist selects tasks based on participant's level of impairment and individual goals. The dosage of ABT will be 30 minutes\u002Fsession, with approximately 15 minutes allocated on each side.",[24],"Other: Training only",[26,30,33],{"type":6,"name":27,"description":11,"armGroupLabels":28,"otherNames":29},"Active Stimulation",[9],null,{"type":6,"name":31,"description":17,"armGroupLabels":32,"otherNames":29},"Sham",[15],{"type":6,"name":34,"description":35,"armGroupLabels":36,"otherNames":29},"Training only","articipants in ABT group will receive ABT only. ABT will concentrate on activities of gross UE movement, grasping, pinching, gross and fine motor skill. The hand grasp task will focus on grasping objects with different shapes and weights (i.e. weighted container and tennis ball) and placing\u002Fremoving them from small storage container; the pinch task involves picking up, translating, and releasing small objects with varied sizes (i.e. blocks, dices, marble balls, nuts, etc.). The training therapist selects tasks based on participant's level of impairment and individual goals. The dosage of ABT will be 30 minutes\u002Fsession, with approximately 15 minutes allocated on each side.",[21],[38],{"name":39,"affiliation":5,"role":40},"Gail Forrest, PhD","STUDY_DIRECTOR",[42,47],{"name":43,"role":44,"phone":45,"phoneExt":29,"email":46},"Fan Zhang, PhD","CONTACT","4015362070","fzhang@kesslerfoundation.org",{"name":39,"role":44,"phone":48,"phoneExt":29,"email":49},"973-324-3518","GForrest@kesslerfoundation.org",[51],{"facility":5,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"RECRUITING","West Orange","New Jersey","07052","United States","US",{"type":59,"coordinates":60},"Point",[61,62],-74.23904,40.79871,{"lat":62,"lon":61},[65,69,73],{"name":66,"role":44,"phone":67,"phoneExt":29,"email":68},"Courtney D Bell","973.965.6629","CBell@kesslerfoundation.org",{"name":70,"role":44,"phone":71,"phoneExt":29,"email":72},"LeighAnn Martinez","973.324.3557","LMartinez@kesslerfoundation.org",{"name":43,"role":44,"phone":29,"phoneExt":29,"email":29},{"type":75,"investigatorFullName":76,"investigatorTitle":77,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"PRINCIPAL_INVESTIGATOR","Fan Zhang","Principal Investigator","100575515","combining-spinal-cord-transcutaneous-stimulation-and-activity-based-training-in-inpatient-rehabilitation-to-facilitate-upper-limb-function-of-individuals-with-acute-to-subacute-cervical-spinal-cord-injury-100575515",false,"NCT06773286","Combining Spinal Cord Transcutaneous Stimulation and Activity-based Training in Inpatient Rehabilitation to Facilitate Upper Limb Function of Individuals with Acute to Subacute Cervical Spinal Cord Injury","Establishing the Feasibility, Safety, and Efficacy of Spinal Cord Transcutaneous Stimulation with Activity-based Training for Upper Extremity Function Recovery in Individuals with Acute to Subacute Tetraplegia","Inclusion Criteria:\n\n* must be at least 18 years of age.\n* must have had a spinal cord injury for less than or equal to 8 weeks.\n* must have a traumatic cervical SCI with lesions (AIS A or B, C5-C7).\n* must have some degree of motor dysfunction in the hand (bilateral UE motor score \\\u003C25).\n* must be medically stable enough to participate in activity-based recovery training.\n* must be able to tolerate spinal cord transcutaneous stimulation, as determined by study staff.\n* must have ability to understand and the willingness to sign an informed consent.\n\nExclusion Criteria:\n\n* have a history of seizures, head trauma and\u002For cognitive deficit\n* have surgically implanted foreign bodies such as a pacemaker, metal plate in the skull, and metal inside the skull\n* have a pressure sore or skin issues.\n* have severe spasticity.\n* in medically unstable condition.\n* have a history of illicit drug abuse.\n* have a history of medical disorders of my heart, lungs, bladder, kidneys or other parts of my body that are unrelated to my spinal cord injury.\n* unable or unwilling to wean from anti-spasticity medication (for an example: baclofen, Xeomin, and Lioresal).\n* unable to meet the attendance requirements.\n* currently enrolled in another interventional research study.\n* unable to follow instructions and maintain alertness during assessments and training.","ALL","18 Years","75 Years",{"count":89,"type":90},30,"ESTIMATED","INTERVENTIONAL",[93],"NA","The purpose of this clinical trial is to understand the safety and practicality of using spinal cord transcutaneous (through the skin) stimulation in an inpatient setting as well as how the combination of activity-based training (ABT) and spinal cord transcutaneous stimulation (scTS) can improve participants' ability to use their hands, arms, and trunk in an inpatient rehabilitation program. The main questions it aims to answer are:\n\n* Is the combination of spinal cord transcutaneous stimulation and ABT is safe and practical when applied to individuals with acute to subacute cervical SCI during inpatient rehabilitation?\n* How the combined intervention can improve hand and arm function when applied to those individuals? The investigators will assess the safety, feasibility, and preliminary efficacy of the combined intervention and compare to a sham control (sham stimulation combined with ABT) and a ABT only group to see if the combined intervention can lead to greater function recovery.\n\nParticipants will:\n\n* Receive one type of the three intervention (scTS+ABT, sham scTS+ABT, or ABT only) for 10 sessions with 30 mins\u002Fsession over 2 weeks.\n* Receive assessment before, during, and immediately after the intervention, and at 1-month, 2-month, and 3-month follow-up visits.",[96],"Spinal Cord Injury Cervical",[98,99,100,101,102],"Spinal Cord Injury","Inpatient Rehabilitation","Upper Extremity","Spinal Cord Transcutaneous Stimulation","Activity-based Training","2025-01-08",{"date":105,"type":106},"2025-01-14","ACTUAL",{"date":108,"type":106},"2024-04-08",{"date":110,"type":90},"2025-12",{"name":5,"class":6},1]