Improving movement and bladder function in people with spinal cord injuries
Official title: Inter-System Closed-Loop Control of Locomotor and Bladder Function in Individuals With Acute Spinal Cord Injury
Run by Kessler Foundation · NCT04879862 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 16 (estimated) |
| Sponsor | Kessler Foundation Academic / other |
| Locations | 1 site (West Orange, New Jersey) |
| Status | Recruiting |
| Started | April 4, 2022 |
| Main results expected | May 28, 2028 |
| Study ends | April 28, 2029 |
| Registry record updated | May 4, 2026 |
| Trial ID | NCT04879862 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Previous studies have shown promising results with epidural stimulation in chronic spinal cord injury patients, indicating potential for success in this acute setting.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Transcutaneous spinal cord stimulation with 4-aminopyridine and intensive rehab for chronic spinal cord injury
This pilot study tests whether combining noninvasive spinal stimulation, dalfampridine, and rigorous rehab is safe and feasible for adults with chronic spinal cord injury and whether it can help improve movement and walking.
-
NG004 for incomplete cervical spinal cord injury
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ZEPU-AI3 Lower Limb Feedback Training and Evaluation Robot in Rehab
This pilot trial tests whether adding the ZEPU-AI3 robotic leg training with real-time feedback to standard rehab helps adults with lower limb motor problems from stroke, spinal cord injury, or similar conditions.
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Combined magnetic stimulation and ultrasound for detrusor overactivity in spinal cord injury
This study tests whether using high-frequency sacral nerve stimulation together with bladder-directed ultrasound can reduce involuntary bladder contractions and improve bladder function in people with spinal cord injury.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.