[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100581646":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":45,"centralContacts":50,"locations":59,"responsibleParty":76,"collaborators":28,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":28,"eligibilityCriteria":85,"healthyVolunteers":81,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":28,"studyType":92,"phases":93,"briefSummary":96,"conditions":97,"keywords":99,"overallStatus":62,"whyStopped":28,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Shirley Ryan AbilityLab","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"4-AP(AM) + STDP stimulation + training + 4-AP(PM)","EXPERIMENTAL","The effects of the functional recovery of the lower-limb muscles will be determined after 40 sessions of twice-daily-dosing 4-AP, STDP stimulation and training.",[13,14,15],"Drug: Dalfampridine","Other: STDP stimulation","Behavioral: Exercise training",{"label":17,"type":18,"description":19,"interventionNames":20},"Placebo(AM) + STDP stimulation + training + Placebo(PM)","PLACEBO_COMPARATOR","The effects of the functional recovery of the lower-limb muscles will be determined after 40 sessions of twice-daily-dosing Placebo, STDP stimulation and training.",[21,14,15],"Drug: Placebo",[23,29,33,40],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Dalfampridine","The study drug (4-AP) will be administered as a 10 mg dose twice a day.",[9],null,{"type":24,"name":30,"description":31,"armGroupLabels":32,"otherNames":28},"Placebo","The placebo provided by the SRAL pharmacy that looks identical to the 4-AP, will be administered twice a day.",[17],{"type":6,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"STDP stimulation","Paired stimulation will be given to the spinal cord and to peripheral nerves so that the signals are received at the spinal cord at a specific interval.",[9,17],[38,39],"Hebbian stimulation","spike timing dependent plasticity",{"type":41,"name":42,"description":43,"armGroupLabels":44,"otherNames":28},"BEHAVIORAL","Exercise training","Lower-limb exercises will involve over-ground walking, treadmill, walking and stair climbing training.",[9,17],[46],{"name":47,"affiliation":48,"role":49},"Monica Perez, PT, PhD","Shirley Ryan Ability Lab","PRINCIPAL_INVESTIGATOR",[51,55],{"name":47,"role":52,"phone":53,"phoneExt":28,"email":54},"CONTACT","312-238-2886","mperez04@sralab.org",{"name":56,"role":52,"phone":57,"phoneExt":28,"email":58},"Bing Chen, PhD","312-238-7895","bchen03@sralab.org",[60],{"facility":61,"status":62,"city":63,"state":64,"zip":65,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"Shirley Ryan Abilitylab","RECRUITING","Chicago","Illinois","60611","United States","US",{"type":69,"coordinates":70},"Point",[71,72],-87.65005,41.85003,{"lat":72,"lon":71},[75],{"name":47,"role":52,"phone":53,"phoneExt":28,"email":54},{"type":49,"investigatorFullName":77,"investigatorTitle":78,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"Monica Perez","Scientific Chair","100581646","phase-1-double-dose-4-ap-on-functional-recovery-after-spinal-cord-injury-100581646",false,"NCT06853015","Double Dose 4-AP on Functional Recovery After Spinal Cord Injury","Effects of Twice-daily Dosing 4-AP on Functional Recovery After Spinal Cord Injury","Inclusion Criteria:\n\n* Male and females between ages 18-85 years\n* SCI 6 months post injury\n* Spinal Cord injury at or above L2\n* ASIA A, B, C, or D, complete or incomplete\n* The ability to perform a small visible contraction with dorsiflexion and hip flexor muscles\n\nExclusion Criteria:\n\n* Uncontrolled medical problems including pulmonary, cardiovascular or orthopedic disease\n* Any history of renal impairment\n* Any debilitating disease prior to the SCI that caused exercise intolerance\n* Premorbid, ongoing major depression or psychosis, altered cognitive status\n* History of head injury or stroke\n* Vascular, traumatic, tumoral, infectious, or metabolic lesion of the brain, even without history of seizure, and without anticonvulsant medication\n* History of seizures or epilepsy\n* Receiving drugs acting primarily on the central nervous system, which lower the seizure threshold (see appendix 2)\n* Pregnant females\n* If a women of child bearing age is unsure of the pregnancy, and does not want to take the pregnancy test\n* Ongoing cord compression or a syrinx in the spinal cord or who suffer from a spinal cord disease such as spinal stenosis, spina bifida, MS, or herniated disk\n* Metal plate in skull\n* Individuals with scalp shrapnel, cochlear implants, or aneurysm clips\n* Individuals taking Bupropion, Dolutegravir, Lacosamide, Trilaciclib, or PR Interval prolonging drugs","ALL","18 Years","85 Years",{"count":90,"type":91},27,"ESTIMATED","INTERVENTIONAL",[94,95],"PHASE1","PHASE2","The purpose of this study is to test a strategy to potentiate functional recovery of lower limb motor function in individuals with spinal cord injury (SCI). The FDA approved drug, Dalfampridine (4-AP). 4-AP will be used twice-daily in combination of Spike-timing-dependent plasticity (STDP) stimulation and STDP stimulation with limb training.",[98],"SCI - Spinal Cord Injury",[100,101,102,103],"spinal cord injury","neurostimulation","4-AP","rehabilitation","2026-06-02",{"date":106,"type":107},"2026-06-03","ACTUAL",{"date":109,"type":107},"2025-02-01",{"date":111,"type":91},"2026-12-30",{"name":5,"class":6},1]