Epidural Stimulation to Restore Voluntary Movement Following Spinal Cord Injury

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-31

Study Completion Date

2026-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Spinal Cord Injuries

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

implanted epidural stimulator

Intervention Type DEVICE

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

Interventions

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implanted epidural stimulator

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No