Status:
NOT_YET_RECRUITING
"Epidural Spinal Cord Stimulation: Addressing Spasticity and Motor Function"
Lead Sponsor:
Kessler Foundation
Conditions:
Spasticity
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study aims to expand the knowledge and capacity for neuromodulation to improve the debilitating effects of severe spasticity (spasms, tonic muscle activity and/or clonus) in persons with spinal c...
Detailed Description
This study aims to expand our knowledge and capacity for neuromodulation to improve the debilitating effects of severe spasticity (spasms, tonic muscle activity and/or clonus) in persons with spinal c...
Eligibility Criteria
Inclusion
- I must be at least 18 years of age
- I must have a non-progressive spinal cord injury (SCI)
- I have met the clinical criteria for an intrathecal baclofen pump
- I am in stable medical condition
Exclusion
- I must not be ventilator dependent
- I must not have untreated painful musculoskeletal dysfunction, fracture or pressure injury
- I must not have untreated psychiatric disorder or ongoing drug abuse, as determined by study staff
- I must not have cardiac, respiratory, bladder, renal or other untreated medical disorder unrelated to SCI
- I must not have had peripheral muscle Botox injections less than 12 months prior to implant
- I must not have a colostomy bag or urostomy
- I must not have any implanted pump (i.e., baclofen pump, pain pump, etc.) prior to randomization
- I must not be pregnant at the time of enrollment or planning to become pregnant during the time course of the study
- I must not have an active implantable device that may interfere with the epidural neurostimulator
Key Trial Info
Start Date :
July 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 15 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05422716
Start Date
July 14 2022
End Date
May 15 2026
Last Update
June 16 2022
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