Recruiting

Spinal Cord Stimulation

Sponsor:

University of Minnesota

Code:

NCT05705453

Conditions

SCI - Spinal Cord Injury

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

Epidural Spinal Cord Stimulation

Study Details

Brief summary:

This study will evaluate the long-term effect of chronic spinal cord stimulation to restore volitional movement for patients with chronic spinal cord injuries.

Conditions

SCI - Spinal Cord Injury

Study ID

NCT05705453

Start date

May 11, 2023

Status verified date

Apr, 2026

Completion date

Apr 1, 2034

Anticipated

Primary completion date

Apr 1, 2033

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 process
  • Stable spinal cord injury
  • International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) neurologic level of injury below C5
  • No ventilator dependency within the last year
  • American Spinal Injury Association (AISA) imparement scale"A" or "B" in the absence of spinal cord stimulation
  • Medically stable in the judgment of the Principal investigator
  • Greater than 1 year since initial injury and at least 6 months from any required spinal instrumentation and 2 months from spinal cord stimulator surgery
  • Has an existing and functional implanted spinal cord stimulator system that is FDA approved and can be corroborated by hospital documentation
  • Spinal imaging of the stimulator system

Exclusion Criteria:

  • Current and anticipated need for opioid pain medications or pain that would prevent full participation in the rehabilitation program in the judgment of the principal investigator
  • Use of botulinum toxin (Botox) injections in the previous six months
  • Clinically significant mental illness in the judgment of the principal investigator
  • Other conditions or medications that would make the subject unable to participate in testing/rehabilitation in the judgment of the principal investigator
  • Nonfunctional spinal cord stimulator or near end-of-life, determined by the PI
  • Current Pregnancy
  • Current pain relief from the spinal cord stimulator if the indication for implantation was for management of chronic pain.

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Volitional EMG power

Assessing the change in volitional EMG power during the Brain Motor Control Assement (BMCA) between nonstimulation baseline and stimulation.

Interventions

Epidural Spinal Cord Stimulation

Stimulation of the spinal cord from the epidural space.

Primary outcome measure

  • Change in Volitional electromyography (EMG) power [ Time Frame: 10 years ]

Central Contacts and Locations

Central contacts

Study Coordinator

612-873-9113estand@umn.edu

Study Coordinator

612-873-9113rnl@umn.edu

Locations

Hennepin County Medical Center

Recruiting

Minneapolis, Minnesota, United States, 55415

Contacts

Tara Nash, FNP

612-873-9113estand@umn.edu

Study Coordinator

rnl@umn.edu

More Information

Sponsor

University of Minnesota

Last update posted

Apr 8, 2026

Last verified

Apr, 2026

Keywords

  • spinal cord stimulation
  • epidural stimulation

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.