Improving movement and bladder function in people with spinal cord injuries
Inter-System Closed-Loop Control of Locomotor and Bladder Function in Individuals With Acute Spinal Cord Injury
This study is testing if a new treatment using epidural stimulation can help people with spinal cord injuries improve their ability to stand, walk, and manage their bladder.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Kessler Foundation Academic / other |
| Locations | 1 site (West Orange, New Jersey) |
| Trial ID | NCT04879862 on ClinicalTrials.gov |
What this trial studies
This study aims to explore the effects of epidural stimulation on locomotion and bladder function in individuals with acute spinal cord injuries. Participants will undergo various training interventions that combine epidural stimulation with stand training, step training, and bladder capacity and voiding efficiency training. The goal is to assess improvements in the ability to stand, walk, and manage bladder function, which are critical for enhancing quality of life. The study also seeks to develop technology that facilitates the integration of these training paradigms for better long-term outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with non-progressive spinal cord injuries between T1 and T10, who are within one year post-injury and have bladder dysfunction.
Not a fit: Patients who are ventilator-dependent, have untreated musculoskeletal issues, or have unrelated cardiovascular or respiratory diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly enhance mobility and bladder control for individuals with spinal cord injuries, improving their overall quality of life.
How similar studies have performed: Previous studies have shown promising results with epidural stimulation in chronic spinal cord injury patients, indicating potential for success in this acute setting.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
West Orange, New Jersey
- Kessler Foundation - Center for Spinal Stimulation — West Orange, New Jersey, United States (Recruiting)
Study contacts
- Study coordinator: Leighann Martinez
- Email: lmartinez@kesslerfoundation.org
- Phone: 973-324-3557
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.