Spinal Cord Injuries
Conditions
Brief summary
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
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.
Interventions
DEVICEimplanted epidural stimulator
implantable multi-programmable neurostimulation system to deliver electrical stimulation to neural targets in the spinal cord
Sponsors
University of Colorado, Denver
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| International Standards for Neurological Classification of Spinal Cord Injury lower extremity motor scores (ISNCSCI-LEMS) | 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
| Measure | Time frame | Description |
|---|---|---|
| The abbreviated World Health Organization Quality of Life (WHOQOL-BREF) | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAndrew C Smith, PT, DPT, PhD
University of Colorado, Denver
Outcome results
None listed