Epidural Stimulation for Spinal Cord Injury
NM
AP
NM
Overseen ByNadine Mansour, MD, MPH, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: University of Minnesota
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
NM
Nadine Mansour, MD, MPH, PhD
Principal Investigator
University of Minnesota
AP
Ann Parr, MD, PhD
Principal Investigator
University of Minnesota
MK
Manda Keller-Ross, PhD, DPT, PT
Principal Investigator
University of Minnesota
Are You a Good Fit for This Trial?
CE-STAND is for adults over 22 with stable, motor-complete spinal cord injury (SCI) between C4 and C7, who have had the injury for more than a year. Participants must be medically stable, able to attend all appointments, understand the study process, and have normal or corrected vision and hearing.Inclusion Criteria
Able to undergo the informed consent/assent process
Medically stable in the judgment of the PI
Intact segmental reflexes below the lesion of injury
See 7 more
Exclusion Criteria
Individuals who have history of recurrent autonomic dysreflexia in the judgment of the PI
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
See 14 more
What Are the Treatments Tested in This Trial?
Interventions
- Epidural Spinal Cord Stimulation System
Trial Overview The trial tests an Epidural Spinal Cord Stimulation System on individuals with chronic cervical SCI focusing on autonomic dysfunction. It aims to improve function and quality of life by addressing areas often overlooked in research.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Spinal injury patientsExperimental Treatment1 Intervention
Experimental: Individuals with cervical SCI comparing stimulation "on" vs "off" longitudinally.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Minnesota
Lead Sponsor
Trials
1,459
Recruited
1,623,000+
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