NCT04879862 Locomotor and Bladder Function in Individuals With Acute Spinal Cord Injury
| NCT ID | NCT04879862 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Claudia Angeli |
| Condition | Spinal Cord Injuries |
| Study Type | INTERVENTIONAL |
| Enrollment | 16 participants |
| Start Date | 2022-04-04 |
| Primary Completion | 2028-05-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 16 participants in total. It began in 2022-04-04 with a primary completion date of 2028-05-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04879862 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Spinal Cord Injuries. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04879862 currently recruiting?
Yes, NCT04879862 is actively recruiting participants. Contact the research team at lmartinez@kesslerfoundation.org for enrollment information.
Where is the NCT04879862 trial being conducted?
This trial is being conducted at West Orange, United States.
Who is sponsoring the NCT04879862 clinical trial?
NCT04879862 is sponsored by Claudia Angeli. The trial plans to enroll 16 participants.