Spinal Cord Injury
Conditions
Keywords
Cervical, Spinal cord injury, Epidural spinal cord stimulation, Autonomic dysfunction
Brief summary
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.
Detailed description
Spinal cord injury (SCI) affects over 18,000 individuals annually, leading to significant motor and autonomic dysfunctions that reduce quality of life (QoL). Epidural spinal cord stimulation (eSCS) has shown potential in restoring function in chronic individuals with SCI. However, research on cervical, and autonomic dysfunction-related SCI remains limited. This study will assess the safety and efficacy of eSCS in improving autonomic and volitional functions, as well as truncal stability, bowel, bladder, and sexual function, and overall QoL. The study is a Phase I/II trial in which participants will serve as their own controls. The Abbott Eterna epidural stimulator system will be implanted, and assessments will occur every three months. The study will be conducted over a period of four years. A total of 36 participants will be enrolled and followed for one year. Bayesian Optimization will be used to determine the most effective stimulation settings, with 15 settings programmed at the end of each visit. FDA and UMN IRB approvals have been secured for the study. Interim reports will be made available through peer-reviewed journals, conference presentations, and clinical network reporting. CE-STAND seeks to advance SCI treatment by expanding eSCS applications in chronic cervical SCI, improving patient outcomes, and reducing healthcare costs.
Interventions
Abbott Eterna system implantable pulse generator (IPG), charger, and TriCentrus lead
Sponsors
University of Minnesota
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of epidural spinal cord stimulator in chronic cervical patients | 1 year | Incidence of adverse events (AEs) and serious adverse events (SAEs) including hypotension, other hemodynamic instability, infection, bleeding, significant pain, spasticity, or cerebrospinal fluid leak. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in blood pressure | 1 year | Measured on tilt table testing. Both systolic and diastolic pressure will be assessed |
| Changes in heart rate | 1 year | Measured on tilt table testing |
| Cognitive function | 1 year | Measured using N-back testing |
| Cerebral blood flow | 1 year | Measured using transcranial doppler |
| Muscle Sympathetic Nerve Activities (MSNA) | 1 year | Microneurolography |
Countries
United States
Contacts
CONTACTAnn Parr, MD, PhD
CONTACTNadine Mansour, MD, MPH, PhD
PRINCIPAL_INVESTIGATORAnn Parr, MD, PhD
University of Minnesota
PRINCIPAL_INVESTIGATORManda Keller-Ross, PhD, DPT, PT
University of Minnesota
PRINCIPAL_INVESTIGATORNadine Mansour, MD, MPH, PhD
University of Minnesota
Outcome results
None listed