Actively Recruiting

Phase 1
Phase 2
Age: 22Years +
All Genders
NCT06410001

CE-STAND: Cervical Epidural STimulation After Neurologic Damage

Led by University of Minnesota · Updated on 2026-03-27

36

Participants Needed

1

Research Sites

228 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

CE-STAND: Cervical Epidural STimulation After Neurologic Damage

Who Can Participate

Age: 22Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Twenty two years of age or older
  • Able to undergo the informed consent/assent process
  • Stable, motor-complete spinal cord injury
  • Spinal cord injury between C4 and C7 with upper extremity weakness
  • ASIA A or B spinal cord injury classification
  • Medically stable as determined by the principal investigator
  • Intact segmental reflexes below the injury site
  • More than 1 year since initial injury and at least 6 months since any spinal instrumentation
  • Normal or corrected vision and sufficient hearing to perform task assessments
  • Willing to attend all scheduled appointments
Not Eligible

You will not qualify if you...

  • Diseases or conditions increasing surgical risk, such as cardiopulmonary issues
  • Need for respiratory support including ventilator or diaphragmatic pacer
  • Unable to stop antiplatelet or anticoagulation medications around surgery
  • History of recurrent autonomic dysreflexia as judged by the principal investigator
  • Severe dysautonomia or history of stroke or heart attack linked to autonomic dysreflexia
  • Failed cardiovascular autonomic dysfunction on tilt table testing
  • Conditions preventing participation in testing or rehabilitation as judged by the principal investigator
  • Participation in another study with fluoroscopic or related radiation exposure within the past 12 months
  • Current or expected need for opioid pain medication or pain limiting participation
  • Clinically significant mental illness as judged by the principal investigator
  • Use of botulinum toxin, intrathecal baclofen pump, or antispasmodics without study approval
  • History of significant depression or drug abuse
  • Volitional movements detected in both lower extremities during EMG testing
  • Unhealed spinal fracture
  • Significant contracture with loss of more than two-thirds range of motion
  • Presence of pressure ulcers
  • Current pregnancy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Minnesota

Minneapolis, Minnesota, United States, 55455

Actively Recruiting

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Research Team

A

Ann Parr, MD, PhD

CONTACT

N

Nadine Mansour, MD, MPH, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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