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Locomotor and Bladder Function in Individuals With Acute Spinal Cord Injury

RecruitingNAAges 18 Years - 65 YearsAllClaudia Angeli
NCT04879862 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. At least 18 years of age 2. non-progressive SCI 3. stable medical condition 4. Inability to stand and step independently 5. unable to voluntarily move all individual joints of the legs 6. no current anti-spasticity medication regimen 7. must not have received botox injections in the prior six months 8. Bladder dysfunction as a result of SCI 9. SCI between T1 and T10 10. no greater than 1 year post injury Exclusion Criteria: 1. ventilator dependent 2. untreated painful musculoskeletal dysfunction, fracture or pressure sore 3. untreated psychiatric disorder or ongoing drug abuse 4. cardiovascular, respiratory, bladder, or renal disease unrelated to SCI 5. pregnant at the time of enrollment or planning to become pregnant during the time course of the study.
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What it tests

  • Epidural stimulation + Stand Training
  • Epidural stimulation + Step Training
  • Epidural stimulation + Bladder Capacity Training
  • Epidural stimulation + Bladder Voiding Efficiency Training
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Where

1 site
Kessler Foundation - Center for Spinal Stimulation
West Orange, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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