[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100537145":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":42,"centralContacts":46,"locations":55,"responsibleParty":80,"collaborators":83,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":24,"eligibilityCriteria":93,"healthyVolunteers":89,"sex":94,"minAge":95,"maxAge":24,"enrollmentInfo":96,"targetDuration":24,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":108,"overallStatus":58,"whyStopped":24,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},{"fullName":5,"class":6},"University of Mississippi Medical Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Transcutaneous spinal stimulation in combination of baclofen\u002Ftizanidine\u002Fplacebo","EXPERIMENTAL","Each participant will receive five distinct interventions:\n\n* Transcutaneous spinal stimulation at 100 Hz for 30 minutes with a placebo\n* Transcutaneous spinal stimulation at 50 Hz for 30 minutes with a placebo\n* Transcutaneous spinal stimulation at 50 Hz for 30 minutes with a single-dose baclofen\n* Transcutaneous spinal stimulation at 50 Hz for 30 minutes with a single-dose tizanidine\n* Transcutaneous spinal stimulation (sham) for 30 minutes with a placebo",[13,14,15,16,17],"Device: Transcutaneous spinal stimulation at 100 Hz","Device: Transcutaneous spinal stimulation at 50 Hz","Combination Product: Transcutaneous spinal stimulation at 50 Hz and single dose of baclofen","Combination Product: Transcutaneous spinal stimulation at 50 Hz and single dose of tizanidine","Device: Sham transcutaneous spinal stimulation",[19,25,29,34,38],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DEVICE","Transcutaneous spinal stimulation at 100 Hz","Transcutaneous spinal stimulation (TSS) is a non-invasive neuromodulation method that uses electrical currents to stimulate sensory fibers. The procedure involves placing surface electrodes midline on the lower back (T11-12 spinal processes) and on each side of the belly button. The stimulation frequency during the intervention is 100 Hz, performed at a sub-motor threshold for 30 minutes.",[9],null,{"type":20,"name":26,"description":27,"armGroupLabels":28,"otherNames":24},"Transcutaneous spinal stimulation at 50 Hz","Transcutaneous spinal stimulation (TSS) is a non-invasive neuromodulation method that uses electrical currents to stimulate sensory fibers. The procedure involves placing surface electrodes midline on the lower back (T11-12 spinal processes) and on each side of the belly button. The stimulation frequency during the intervention is 50 Hz, performed at a sub-motor threshold for 30 minutes.",[9],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":24},"COMBINATION_PRODUCT","Transcutaneous spinal stimulation at 50 Hz and single dose of baclofen","Transcutaneous spinal stimulation (TSS) is a non-invasive neuromodulation method that uses electrical currents to stimulate sensory fibers. The procedure involves placing surface electrodes midline on the lower back (T11-12 spinal processes) and on each side of the belly button. The stimulation frequency during the intervention is 50 Hz, performed at a sub-motor threshold for 30 minutes.\n\nStudy participants will receive a single dose of baclofen, a centrally-acting muscle relaxant belonging to the class of gamma-aminobutyric acid (GABA) analogs. Its primary mechanism involves acting on the GABA receptors in the brain and spinal cord to decrease spasticity. Participants will receive baclofen orally at a single dose of 10 mg.",[9],{"type":30,"name":35,"description":36,"armGroupLabels":37,"otherNames":24},"Transcutaneous spinal stimulation at 50 Hz and single dose of tizanidine","Transcutaneous spinal stimulation (TSS) is a non-invasive neuromodulation method that uses electrical currents to stimulate sensory fibers. The procedure involves placing surface electrodes midline on the lower back (T11-12 spinal processes) and on each side of the belly button. The stimulation frequency during the intervention is 50 Hz, performed at a sub-motor threshold for 30 minutes.\n\nStudy participants will receive a medication called tizanidine, which is an alpha-2 adrenergic agonist. This medication works by inhibiting presynaptic motor neurons, resulting in a reduction of muscle spasticity. It is commonly used to manage spasticity caused by neurological disorders. Each participant will be given a single oral dose of 4 mg of tizanidine as part of this trial.",[9],{"type":20,"name":39,"description":40,"armGroupLabels":41,"otherNames":24},"Sham transcutaneous spinal stimulation","Sham Transcutaneous spinal stimulation (TSS) involves placing two surface electrodes midline on the lower back (T11-12 spinal processes). The stimulation frequency during the intervention is 50 Hz, performed for 30 minutes.",[9],[43],{"name":44,"affiliation":5,"role":45},"Matthias J Krenn, Ph.D.","PRINCIPAL_INVESTIGATOR",[47,51],{"name":44,"role":48,"phone":49,"phoneExt":24,"email":50},"CONTACT","601-364-3413","mkrenn@umc.edu",{"name":52,"role":48,"phone":53,"phoneExt":24,"email":54},"Dobrivoje S Stokic, M.D., D.Sc.","601-364-3314","dstokic@mmrcrehab.org",[56,73],{"facility":57,"status":58,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"Methodist Rehabilitation Center","RECRUITING","Jackson","Mississippi","39216","United States","US",{"type":65,"coordinates":66},"Point",[67,68],-90.18481,32.29876,{"lat":68,"lon":67},[71],{"name":72,"role":48,"phone":53,"phoneExt":24,"email":54},"Dobrivoje S Stokic, MD, DSc",{"facility":5,"status":58,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":74,"geoPoint":76,"contacts":77},{"type":65,"coordinates":75},[67,68],{"lat":68,"lon":67},[78],{"name":79,"role":48,"phone":49,"phoneExt":24,"email":50},"Matthias J Krenn, PhD",{"type":45,"investigatorFullName":81,"investigatorTitle":82,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Matthias J. Krenn, PhD","Assistant Professor",[84,85],{"name":57,"class":6},{"name":86,"class":6},"The Craig H. Neilsen Foundation","100537145","early-phase-1-neuromodulation-to-reduce-muscle-stiffness-following-spinal-cord-injury-100537145",false,"NCT06274021","Neuromodulation to Reduce Muscle Stiffness Following Spinal Cord Injury","Shared and Distinct Antispastic Effects of Electrical and Pharmacological Neuromodulation","Inclusion criteria:\n\n* Age 18 years or older\n* History of spinal cord injury\n* Time since diagnosis longer than six months\n* Presence of spasticity in the lower limbs (≥ 3 on the Numerical Rating Scale of Spasticity Severity \\[range from 0 to 10\\])\n* If needed, agreement to reduce antispastic medication\n\nExclusion criteria:\n\n* Neurological level of spinal cord injury below T11\n* Ventilatory-dependent\n* Change in neurological status over the past 2 months\n* Rigidity, contraction, or passive range of motion of less than 40 deg in both knee joints\n* Botulinum toxin injections in lower extremities in the previous 3 months before enrollment\n* Systolic blood pressure at rest lower than 90 mm Hg\n* Implanted active devices (e.g., intrathecal baclofen pumps)\n* Passive implants (plates, screws) between T11 and L2 vertebras\n* Skin conditions precluding placement of electrodes\n* Pressure ulcers stage 2 or higher on the gluteal area or lower extremities\n* Receiving antibiotics for infections\n* Pregnancy\n* Difficulty following instructions\n* Participation in another study with investigational drugs or devices within the 30 days preceding and during the present study\n* Other medical risks\u002Fcontraindications as determined by the study physicians","ALL","18 Years",{"count":97,"type":98},16,"ESTIMATED","INTERVENTIONAL",[101],"EARLY_PHASE1","People with spinal cord injuries may experience muscle tightness or uncontrollable spasms. This study is being conducted to investigate whether transcutaneous spinal stimulation can improve these symptoms. Transcutaneous spinal stimulation is a non-surgical intervention by applying electrical currents using skin electrodes over the lower back and belly.\n\nThe investigators want to see how well the intervention of transcutaneous spinal stimulation performs by testing different levels of stimulation pulse rates. Also, transcutaneous spinal stimulation is compared to muscle relaxants such as baclofen and tizanidine, commonly given to people with spinal cord injuries, to reduce muscle stiffness and spasms. By doing this, the investigators hope to discover if transcutaneous spinal stimulation similarly reduces muscle spasms and stiffness or if combining both methods works best. This could help improve treatment options for people with spinal cord injuries in the future.",[104,105,106,107],"Spinal Cord Injuries","Spinal Cord Injury","Spinal Cord Injury Cervical","Spinal Cord Injury Thoracic",[105,109,110,111,112,113,114,115,116,117],"Neuromodulation","Electrical Stimulation","Spinal Cord Stimulation","Spasticity","Transcutaneous Spinal Stimulation","Lower extremity","Transcutaneous spinal cord stimulation","Paralysis","Spinal reflex","2024-06-28",{"date":120,"type":121},"2024-07-01","ACTUAL",{"date":123,"type":121},"2024-03-01",{"date":125,"type":98},"2025-12-31",{"name":5,"class":6},2]