Epidural Stimulation for Spinal Cord Injury Recovery
Locomotor and Bladder Function in Individuals With Acute Spinal Cord Injury
Recruiting
N/AInterventional Study
Spinal Cord Injuries
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 – 65
Sex
Any
Study type
Interventional
Purpose
Other
Participants needed
16 (estimated)
Sponsor
Claudia Angeli · Other
Who this trial is looking for
This trial is looking for adults with recent spinal cord injuries who cannot stand or walk on their own. Participants will undergo a treatment called epidural stimulation to see if it helps with standing, walking, and bladder function.
Are You a Good Fit for This Trial?
Must not be takingAnti-spasticity medicationsBotox
You may be able to join if
I am at least 18 years old
I have a spinal cord injury that is not getting worse
I have a stable medical condition
I cannot stand or step independently
I cannot move my leg joints on my own
I have bladder problems due to my spinal cord injury
My spinal cord injury happened less than a year ago
My injury is between T1 and T10
You may not be able to join if
I depend on a ventilator to breathe
I have untreated pain from injuries or sores
I have an untreated psychiatric disorder or drug abuse problem
I have heart, lung, bladder, or kidney disease that is not related to my injury
I am pregnant or planning to become pregnant during the study
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
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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 individual…
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.
Trial Locations
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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…
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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