[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100430037":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":27,"centralContacts":40,"locations":46,"responsibleParty":68,"collaborators":72,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":78,"sex":84,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":27,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":49,"whyStopped":27,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Kessler Foundation","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Locomotion","EXPERIMENTAL","Participants will receive 160 locomotor training sessions with epidural stimulation. These sessions may occur once a day (stand and step will alternate days) or twice a day (stand and step on the same day) as recommended by the study physician. Participants will train 5 days per week and each session will last between 1 to 1.5 hours.",[13,14],"Combination Product: Epidural stimulation + Stand Training","Combination Product: Epidural stimulation + Step Training",{"label":16,"type":10,"description":17,"interventionNames":18},"Bladder+Locomotion","Participants will receive 80 sessions of bladder training alone followed by 80 sessions of locomotor training sessions with epidural stimulation. They will be asked to continue with your bladder training once you start locomotor training. Locomotor Training sessions may occur once a day (stand and step will alternate days) or twice a day (stand and step on the same day) as recommended by the study physician. Participants will train 5 days per week and each session will last between 1 to 1.5 hours.",[13,14,19,20],"Combination Product: Epidural stimulation + Bladder Capacity Training","Combination Product: Epidural stimulation + Bladder Voiding Efficiency Training",[22,28,32,36],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"COMBINATION_PRODUCT","Epidural stimulation + Stand Training","Participants may use a standing apparatus or a less assistive device such as walker or cane. In case of upper limbs and trunk control insufficient for safely using the standing apparatus, participants will be placed on the treadmill, and a body weight support system. In this case, the level of body weight support will be continuously reduced as the individuals increase their ability to bear weight. A trainer positioned behind the participant will aid in pelvis and trunk stabilization. Trainer(s) positioned at the lower limb will provide manual facilitation for knee extension during standing. Manual facilitation at the trunk-pelvis and at the legs will be used only when needed.Participants will be encouraged to stand for as long as possible throughout the training session, with the goal to stand for 60 minutes with the least amount of assistance.",[16,9],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"Epidural stimulation + Step Training","Participants may be placed on the treadmill in an upright position and suspended in a harness. All trainers are careful to provide manual assistance only when needed. A trainer positioned behind the research participant will aid in pelvis and trunk stabilization, as well as appropriate weight shifting and hip rotation during the step cycle. Trainers positioned at each limb will provide manual assistance to promote knee extension and knee flexion and toe clearance. Research participants will step at various body weight load and speed. Research participants will take a break and rest at any time they feel the need to during the session. If independence is achieved during stepping, some training might be performed overground with appropriate assistive device and manual assistance to maintain participant safety. Participants will be encouraged to step for 60 minutes with the least amount of assistance. Seated or standing resting periods will occur when requested by the individuals",[16,9],{"type":23,"name":33,"description":34,"armGroupLabels":35,"otherNames":27},"Epidural stimulation + Bladder Capacity Training","We will initially conduct daily training for capacity in a supervised on-site lab setting. Optimal configurations will be used. The storage phase configuration will be used until the time for voiding\u002Fcatheterization. The training procedure will be repeated for up to 8 hours daily on-site until three consecutive stable days of maintaining a consistent capacity values are achieved and deemed safe. In the home setting, participants will record blood pressure values, voided and residual volumes. Participants will return to the lab the following day for monitoring and testing. If assessments show stable outcomes, participants will be allowed to train at home for 7 consecutive days, prior to returning to the lab for clinical evaluation (urodynamics and questionnaires). On the return visit, if their storage\u002Fvoiding outcomes remained stable over the 7 days, they will be able to start the home-based training for bladder capacity.",[16],{"type":23,"name":37,"description":38,"armGroupLabels":39,"otherNames":27},"Epidural stimulation + Bladder Voiding Efficiency Training","We will conduct training for voiding efficiency in a supervised on-site lab setting while the participant continues his\u002Fher training for capacity. Voiding without catheterization will be attempted. The training procedure will be repeated for up to 8 hours on-site until three stable days of maintaining a consistent voiding efficiency are achieved and deemed safe. The participant will be sent home for one day to perform the stimulation at home. In the home setting, participants will record blood pressure values, voided and residual volumes. Participants will return to the lab the following day for monitoring and testing. If assessments show stable outcomes, participants will be allowed to train at home for 7 consecutive days, prior to returning to the lab for clinical evaluation and questionnaires. On the return visit, if their storage\u002Fvoiding outcomes remained stable over the 7 days, they will be able to start the home program integrating bladder training for capacity and voiding",[16],[41],{"name":42,"role":43,"phone":44,"phoneExt":27,"email":45},"Leighann Martinez","CONTACT","973-324-3557","lmartinez@kesslerfoundation.org",[47],{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Kessler Foundation - Center for Spinal Stimulation","RECRUITING","West Orange","New Jersey","07052","United States","US",{"type":56,"coordinates":57},"Point",[58,59],-74.23904,40.79871,{"lat":59,"lon":58},[62,63,66],{"name":42,"role":43,"phone":44,"phoneExt":27,"email":45},{"name":64,"role":65,"phone":27,"phoneExt":27,"email":27},"Claudia Angeli, PhD","PRINCIPAL_INVESTIGATOR",{"name":67,"role":65,"phone":27,"phoneExt":27,"email":27},"Maxwell Boakye, MD",{"type":69,"investigatorFullName":70,"investigatorTitle":71,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"SPONSOR_INVESTIGATOR","Claudia Angeli","Associate Professor",[73],{"name":74,"class":75},"National Institute of Neurological Disorders and Stroke (NINDS)","NIH","100430037","locomotor-and-bladder-function-in-individuals-with-acute-spinal-cord-injury-100430037",false,"NCT04879862","Locomotor and Bladder Function in Individuals With Acute Spinal Cord Injury","Inter-System Closed-Loop Control of Locomotor and Bladder Function in Individuals With Acute Spinal Cord Injury","MC-PP-3","Inclusion Criteria:\n\n1. At least 18 years of age\n2. non-progressive SCI\n3. stable medical condition\n4. Inability to stand and step independently\n5. unable to voluntarily move all individual joints of the legs\n6. no current anti-spasticity medication regimen\n7. must not have received botox injections in the prior six months\n8. Bladder dysfunction as a result of SCI\n9. SCI between T1 and T10\n10. no greater than 1 year post injury\n\nExclusion Criteria:\n\n1. ventilator dependent\n2. untreated painful musculoskeletal dysfunction, fracture or pressure sore\n3. untreated psychiatric disorder or ongoing drug abuse\n4. cardiovascular, respiratory, bladder, or renal disease unrelated to SCI\n5. pregnant at the time of enrollment or planning to become pregnant during the time course of the study.","ALL","18 Years","65 Years",{"count":88,"type":89},16,"ESTIMATED","INTERVENTIONAL",[92],"NA","The loss of movement and walking ability significantly affects quality of life after spinal cord injury. In addition, bladder dysfunction consistently ranks as one of the top disorders affecting quality of life after spinal cord injury. The overall objective of this study is to demonstrate that epidural stimulation may be a method for improving stepping, standing and bladder function in individuals with spinal cord injury. With the use of epidural stimulation, the investigators propose to investigate how well the participant can stand and walk and how well the participant's bladder can store or hold urine as well as void or empty urine. The results of this study may aid in the development of treatments to help individuals with spinal cord injuries that are unable to stand or walk and have impaired bladder function.",[95],"Spinal Cord Injuries",[97,98,99],"locomotion","epidural stimulation","bladder function","2026-04-28",{"date":102,"type":103},"2026-05-04","ACTUAL",{"date":105,"type":103},"2022-04-04",{"date":107,"type":89},"2029-04-28",{"name":70,"class":6},1]