Epidural Stimulation to Restore Voluntary Movement Following Spinal Cord Injury

University of Colorado Denver (CU Denver)

Status: Not yet enrolling

Conditions: Spinal Cord Injuries

Treatments: Device: implanted epidural stimulator

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05966896

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

23-0202

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

Epidural stimulation with Physical Therapy

Experimental group

Description:

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.

Treatment:

Device: implanted epidural stimulator