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CE-STAND: Cervical Epidural STimulation After Neurologic Damage

RecruitingPhase 1, Phase 2Ages 22 Years - anyAllUniversity of Minnesota
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In plain words

What the trial is, and whether it could suit you

CE-STAND aims to address three areas under-represented in research: chronic, cervical, and autonomic dysfunction. It is both significant and highly impactful, as treating autonomic dysfunction could substantially improve function and quality of life (QoL) in chronic cervical SCI patients.

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

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Twenty two years of age or older * Able to undergo the informed consent/assent process * Stable, motor-complete SCI * Discrete SCI between C4 and C7 (upper extremity weakness) * ASIA A or B SCI Classification * Medically stable in the judgment of the PI * 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 * Normal or corrected-to-normal vision to accurately perceive visual stimuli on the N-back task screen, and sufficient hearing ability to accurately perceive auditory stimuli during the task * Willing to attend all scheduled appointments Exclusion Criteria: * Diseases and conditions that would increase the morbidity and mortality of this surgery such as cardiopulmonary. * Individuals who require respiratory support, including ongoing or intermittent use of a ventilator and/or diaphragmatic pacer * Inability to withhold antiplatelet/anticoagulation agents perioperatively * Individuals who have history of recurrent autonomic dysreflexia in the judgment of the PI * Significant dysautonomia that would prohibit rehabilitation or any history of cerebrovascular accident or myocardial infarction associated with autonomic dysreflexia. A single tilt table test with syncope, presyncope, or SBP \< 50 or \> 200 * Failure to exhibit cardiovascular autonomic dysfunction on tilt table testing * Other conditions that would make the subject unable to participate in testing/rehabilitation in the judgment of the PI * Patients who have participated in another study within the last 12 months in which they have received fluoroscopic or other related radiation exposure * Current and anticipated need for opioid pain medications or pain that would prevent full participation in the program in the judgment of the PI * Clinically significant mental illness in the judgment of the PI * Treatment with botulinum toxin, intrathecal baclofen pump, and antispasmodics will not be permitted unless discussed with and approved by the study PI * Patients with a history of significant depression or drug abuse * Volitional movements present during EMG testing in bilateral lower extremities * Unhealed spinal fracture * Presence of significant contracture with loss of greater than two-thirds range of motion * Presence of pressure ulcers * Current Pregnancy
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What it tests

  • Epidural Spinal Cord Stimulation System
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Where

1 site
University of Minnesota
Minneapolis, 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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