Epidural Stimulation to Restore Voluntary Movement Following Spinal Cord Injury

April 2, 2025 updated by: University of Colorado, Denver

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. American Spinal Injury Association Impairment Scale B spinal cord injury diagnosis
  2. Beyond 6 months of injury date
  3. Spinal cord injury at a level range of cervical 7 to thoracic 8 (C7-T8) with signs of upper motor neuron injury
  4. 18 years or older
  5. Height 5'1" to 6'3"
  6. Weight 250 lbs or less
  7. Sufficient upper extremity strength to manage a stability aide
  8. Magnetic resonance imaging evidence of spared spinal cord neural fibers

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Epidural stimulation with Physical Therapy

Stimulation parameters will be optimized for each lower extremity and joint movement. During physical therapy sessions, electrode configurations may be adjusted as needed to optimize stimulation frequencies, and voltage intensity ranges to best enable voluntary control of lower extremity (ankle, knee, and hip) flexion and extension, as well as standing.

Intensive physical therapy will consist of 3 visits per week over the course of 6 months directed by a licensed physical therapist with over a decade of experience working with individuals with spinal cord injury, and the epidural stimulator will be ON continuously during these sessions. Physical therapy will involve neurorehabilitation to facilitate voluntary lower extremity movement in the presence of stimulation, with the research participants in the supine, seated, and standing positions.
Device: implanted epidural stimulator
implantable multi-programmable neurostimulation system to deliver electrical stimulation to neural targets in the spinal cord

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at day 1, at month 7, and at month 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at day 1, at month 7, and at month 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

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

Investigators

  • Principal Investigator: Andrew C Smith, PT, DPT, PhD, University of Colorado, Denver

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2025

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

July 6, 2023

First Submitted That Met QC Criteria

July 17, 2023

First Posted (Actual)

August 1, 2023

Study Record Updates

Last Update Posted (Actual)

April 3, 2025

Last Update Submitted That Met QC Criteria

April 2, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-0202
  • 1K01HD106928-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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