Recruiting

Epidural Stimulation

Sponsor:

University of Minnesota

Code:

NCT03026816

Conditions

Spinal Cord Injuries

Paraplegia, Complete

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

Epidural Spinal Cord Stimulation

Study Details

Brief summary:

This study will evaluate a method to optimize parameter settings in epidural spinal cord stimulation used to recover lower extremity volitional movement. The study will also characterize improvement in autonomic function (such as blood pressure control) and other functions related to spinal cord injury.

Conditions

Spinal Cord Injuries

Paraplegia, Complete

Study ID

NCT03026816

Start date

Aug 7, 2017

Status verified date

Apr, 2026

Completion date

Jan, 2028

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 22 years of age or older
  • Able to undergo the informed consent/assent process
  • Stable, motor-complete paraplegia
  • Discrete spinal cord injury between C6 and T10
  • ASIA A or B Spinal Cord Injury Classification
  • Medically stable in the judgement of the principal investigator
  • 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
  • Willing to attend all scheduled appointments

Exclusion Criteria:

  • Diseases and conditions that would increase the morbidity and mortality of spinal cord injury surgery (e.g. cardiopulmonary issues)
  • Inability to withhold antiplatelet/anticoagulation agents perioperatively
  • Significant dysautonomia that would prohibit rehabilitation or assisted standing or any history of CVA or MI associated with autonomic dysreflexia. A single tilt table test with syncope, presyncope, or SBP < 50 or >200.
  • Other conditions that would make the subject unable to participate in testing/rehabilitation in the judgement of the principal investigator
  • Current and anticipated need for opioid pain medications or pain that would prevent full participation in the rehabilitation program in the judgement of the principal investigator
  • Clinically significant mental illness in the judgement of the principal investigator
  • Botulinum toxin injections in the previous 6 months
  • Volitional movements present during EMG testing in bilateral lower extremities
  • Unhealed spinal fracture
  • Presence of significant contracture
  • Presence of pressure ulcers
  • Recurrent urinary tract infection refractory to antibiotics
  • Current Pregnancy

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Epidural Spinal Cord Stimulation

Epidural Spinal Cord Stimulation

Interventions

Epidural Spinal Cord Stimulation

epidural spinal cord stimulator

Primary outcome measure

  • Change in Volitional Response Index Magnitude [ Time Frame: Months: 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 ]

Central Contacts and Locations

Central contacts

Study Coordinator

612-873-9113estand@umn.edu

David Darrow, MD MPH

612-217-4290estand@umn.edu

Locations

Hennepin County Medical Center

Recruiting

Minneapolis, Minnesota, United States, 55415

Contacts

David Darrow, MD MPH

612-217-4290estand@umn.edu

Study Coordinator

612-873-9113estand@umn.edu

Principal Investigator:

David Darrow, MD MPH

More Information

Sponsor

University of Minnesota

Last update posted

Apr 8, 2026

Last verified

Apr, 2026

Keywords

  • epidural stimulation
  • 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 2026-04-08.