Status:
RECRUITING
Locomotor and Bladder Function in Individuals With Acute Spinal Cord Injury
Lead Sponsor:
Claudia Angeli
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Spinal Cord Injuries
Eligibility:
All Genders
18-65 years
Phase:
NA
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 quali...
Detailed Description
While the investigators have demonstrated the benefits of scES in chronic SCI with one of the largest series (23 patients to date) the investigators are acutely aware of persistent gaps that need to b...
Eligibility Criteria
Inclusion
- At least 18 years of age
- non-progressive SCI
- stable medical condition
- Inability to stand and step independently
- unable to voluntarily move all individual joints of the legs
- no current anti-spasticity medication regimen
- must not have received botox injections in the prior six months
- Bladder dysfunction as a result of SCI
- SCI between T1 and T10
- no greater than 1 year post injury
Exclusion
- ventilator dependent
- untreated painful musculoskeletal dysfunction, fracture or pressure sore
- untreated psychiatric disorder or ongoing drug abuse
- cardiovascular, respiratory, bladder, or renal disease unrelated to SCI
- pregnant at the time of enrollment or planning to become pregnant during the time course of the study.
Key Trial Info
Start Date :
April 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 28 2028
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04879862
Start Date
April 4 2022
End Date
April 28 2028
Last Update
August 15 2025
Active Locations (1)
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1
Kessler Foundation - Center for Spinal Stimulation
West Orange, New Jersey, United States, 07052