Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT05966896

Epidural Stimulation to Restore Voluntary Movement Following Spinal Cord Injury

This proof-of-concept case series will prospectively use magnetic resonance imaging (MRI) evidence of spared spinal cord neural fibers to guide the selection of 2 research participants to receive a surgically implanted epidural stimulator with the goal of restoring voluntary movement after spinal cord injury (SCI).

Because MRI evidence of spared spinal cord neural fibers demonstrated significant relationships with responsiveness to epidural stimulation in SCI in retrospective studies, the proposed study is a traditional feasibility study - a prospective investigation to be used to capture preliminary safety and effectiveness information to determine if MRI can/should be used in planning a future pivotal study.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Anschutz

Aurora, Colorado, 80045, United States

About this study

This is an investigator-initiated proof of concept study performed at the University of Colorado Anschutz Medical Campus (CU Anschutz).

This 2-case proof-of-concept study will include 2 research participants with motor-complete SCI to evaluate the performance of the Medtronic epidural stimulator for restoring voluntary movement below the level of injury.

Participants will be enrolled at CU Anschutz. Screening data will be reviewed to determine participant eligibility. Two participants who meet all inclusion criteria and none of the exclusion criteria will be entered into the study.

The following treatment regimen will be used: epidural stimulation + 6 months of intensive outpatient physical therapy.

Total duration of study participation will be 8 months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • American Spinal Injury Association Impairment Scale B spinal cord injury diagnosis
  • Beyond 6 months of injury date
  • Spinal cord injury at a level range of cervical 7 to thoracic 8 (C7-T8) with signs of upper motor neuron injury
  • 18 years or older
  • Height 5'1" to 6'3"
  • Weight 250 lbs or less
  • Sufficient upper extremity strength to manage a stability aide
  • Magnetic resonance imaging evidence of spared spinal cord neural fibers

Exclusion criteria

  • Claustrophobia and/or other contraindications to magnetic resonance imaging
  • Unstable or symptomatic cardiorespiratory issues, in the opinion of the investigators
  • Recent (within 3 months) history of fracture, contractures, pressure sore, deep vein thrombosis, urinary tract infection, or other infections that might interfere with interventions
  • Contraindications to epidural stimulator implantation surgery
  • Received botox injections into the lower extremities within the past 6 months
  • Pregnancy
  • Cauda Equina injury
  • Any other neurological disorder besides spinal cord injury

Treatment and study plan

implanted epidural stimulator

Device

implantable multi-programmable neurostimulation system to deliver electrical stimulation to neural targets in the spinal cord

Primary outcomes

  1. International Standards for Neurological Classification of Spinal Cord Injury lower extremity motor scores (ISNCSCI-LEMS)

    Time frame: at day 1, at month 7, and at month 8

    International Standards for Neurological Classification of Spinal Cord Injury lower extremity motor scores (ISNCSCI-LEMS) will be used to measure the degree of voluntary motor change. LEMS is conducted with the participant lying supine and five key muscle groups on each side are tested for their ability to contract against gravity and resistance. ISNCSCI motor testing has been shown to have adequate to excellent interrater reliability in individuals with spinal cord injury, and is a valid tool for this population.

Secondary outcomes

  1. The abbreviated World Health Organization Quality of Life (WHOQOL-BREF)

    Time frame: at day 1, at month 7, and at month 8

    The abbreviated World Health Organization Quality of Life (WHOQOL-BREF) instrument will be used to measure the degree of participants' perception of change in quality of life after stimulator implantation. The WHOQOL-BREF assesses quality of life within the context of an individual's culture, value systems, personal goals, standards, and concerns. It has been studied and highly recommended for individuals with spinal cord injury. Scores for the abbreviated World Health Organization Quality of Life instrument range from 0 - 100, with higher scores indicating a better outcome.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

Epidural Stimulation to Restore Voluntary Movement Following Spinal Cord Injury: Spared Fibers Proof-of-concept Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 1, 2023
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.