Epidural Stimulation to Restore Voluntary Movement Following Spinal Cord Injury

Study Overview
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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.

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.

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

Conditions
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Spinal Cord Injuries

Intervention / Treatment
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* Device: implanted epidural stimulator


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Epidural stimulation with Physical Therapy<br>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<br>* implantable multi-programmable neurostimulation system to deliver electrical stimulation to neural targets in the spinal cord<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Standards for Neurological Classification of Spinal Cord Injury lower extremity motor scores (ISNCSCI-LEMS) | 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) | 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 |