RecruitingNot ApplicableNCT03026816
Epidural Stimulation After Neurologic Damage
Epidural Stimulation for Spinal Cord Injury
Sponsor
University of Minnesota
Enrollment
100 participants
Start Date
Aug 7, 2017
Study Type
INTERVENTIONAL
Conditions
Summary
This study will evaluate a method to optimize parameter settings in epidural spinal cord stimulation used to recover lower extremity volitional movement. The study will also characterize improvement in autonomic function (such as blood pressure control) and other functions related to spinal cord injury.
Eligibility
Min Age: 22 Years
Inclusion Criteria9
- years of age or older
- Able to undergo the informed consent/assent process
- Stable, motor-complete paraplegia
- Discrete spinal cord injury between C6 and T10
- ASIA A or B Spinal Cord Injury Classification
- Medically stable in the judgement of the principal investigator
- Intact segmental reflexes below the lesion of injury
- Greater than 1 year since initial injury and at least 6 months from any required spinal instrumentation
- Willing to attend all scheduled appointments
Exclusion Criteria13
- Diseases and conditions that would increase the morbidity and mortality of spinal cord injury surgery (e.g. cardiopulmonary issues)
- Inability to withhold antiplatelet/anticoagulation agents perioperatively
- Significant dysautonomia that would prohibit rehabilitation or assisted standing or any history of CVA or MI associated with autonomic dysreflexia. A single tilt table test with syncope, presyncope, or SBP \< 50 or \>200.
- Other conditions that would make the subject unable to participate in testing/rehabilitation in the judgement of the principal investigator
- Current and anticipated need for opioid pain medications or pain that would prevent full participation in the rehabilitation program in the judgement of the principal investigator
- Clinically significant mental illness in the judgement of the principal investigator
- Botulinum toxin injections in the previous 6 months
- Volitional movements present during EMG testing in bilateral lower extremities
- Unhealed spinal fracture
- Presence of significant contracture
- Presence of pressure ulcers
- Recurrent urinary tract infection refractory to antibiotics
- Current Pregnancy
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Interventions
DEVICEEpidural Spinal Cord Stimulation
epidural spinal cord stimulator
Locations(1)
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NCT03026816
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