Recruiting
Phase 1
Phase 2

Observational Study

Sponsor:

University of Minnesota

Code:

NCT06410001

Conditions

Spinal Cord Injury

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

Epidural Spinal Cord Stimulation System

Study Details

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.

Conditions

Spinal Cord Injury

Study ID

NCT06410001

Start date

Mar 15, 2026

Status verified date

Mar, 2026

Completion date

Jul 30, 2030

Anticipated

Primary completion date

May 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

36 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Spinal injury patients

Experimental: Individuals with cervical SCI comparing stimulation "on" vs "off" longitudinally.

Interventions

Epidural Spinal Cord Stimulation System

Abbott Eterna system implantable pulse generator (IPG), charger, and TriCentrus lead

Primary outcome measure

  • Safety of epidural spinal cord stimulator in chronic cervical patients [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Ann Parr, MD, PhD

612-625-4102ce-stand@umn.edu

Nadine Mansour, MD, MPH, PhD

ce-stand@umn.edu

Locations

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Ann Parr, MD, PhD

612-625-4102amparr@umn.edu

More Information

Sponsor

University of Minnesota

Last update posted

Mar 27, 2026

Last verified

Mar, 2026

Keywords

  • Cervical
  • Spinal cord injury
  • Epidural spinal cord stimulation
  • Autonomic dysfunction

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Minnesota on 2026-03-27.