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โ† Trials
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Addressing Spasticity and Motor Function With Epidural Spinal Cord Stimulation

RecruitingNAAges 22 Years - anyAllKessler Foundation
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In plain words

What the trial is, and whether it could suit you

The purpose of this study is to investigate treating severe spasticity in persons with spinal cord injury by implanting a device in the body that delivers electrical stimulation around the spinal cord (spinal cord epidural stimulation). This study will be closely monitoring a program designed to treat spasticity using an epidural stimulator to better understand its effects on spasticity and voluntary movement.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. At least 22 years of age 2. Post 1 year non-progressive SCI 3. Stable medical condition (cleared by the study physician and do not have any medical conditions that would interfere with study procedures) 4. Diagnosed with and treated for severe spasticity at least 6 months ago Exclusion Criteria: 1. ventilator dependent 2. untreated painful musculoskeletal dysfunction, fracture or pressure injury 3. untreated psychiatric disorder or ongoing drug abuse 4. cardiac, respiratory, bladder, renal or other untreated medical disorder unrelated to SCI 5. Botulinum toxin injections (such as Botox) or other injections to manage spasms (such as phenol or alcohol) in any muscle or bladder less than 6 months prior to implant 6. colostomy bag, urostomy 7. Any active implantable devices or implanted pump (such as a baclofen pump, pain pump, etc.) 8. pregnant at the time of enrollment or planning to become pregnant during the time course of the study 9. Contraindications to MRI imaging (e.g., pacemaker, metallic foreign body, aneurysm clip) 10. Imaging findings that determine the area of spine the stimulation device would be implanted is not suitable for surgery (such as implanted hardware interference or additional deterioration/injury of spinal cord at or below the region) 11. Severe muscle contractures 12. unable to operate a touch screen
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What it tests

  • Epidural implant stimulation device
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Where

1 site
Kessler Foundation
West Orange, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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