SCI - Spinal Cord Injury
Conditions
Keywords
spinal cord stimulation, epidural stimulation
Brief summary
This study will evaluate the long-term effect of chronic spinal cord stimulation to restore volitional movement for patients with chronic spinal cord injuries.
Detailed description
Participants will be enrolled in this study for the duration of 10 years. They will need to come to Minneapolis twice a year for the Brain Motor Control Assessment and will be given different settings within their Spinal Cord Stimulator (SCS) programing.
Interventions
Stimulation of the spinal cord from the epidural space.
Sponsors
University of Minnesota
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 22 years of age or older * Able to undergo the informed consent process * Stable spinal cord injury * International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) neurologic level of injury below C5 * No ventilator dependency within the last year * American Spinal Injury Association (AISA) imparement scaleA or B in the absence of spinal cord stimulation * Medically stable in the judgment of the Principal investigator * Greater than 1 year since initial injury and at least 6 months from any required spinal instrumentation and 2 months from spinal cord stimulator surgery * Has an existing and functional implanted spinal cord stimulator system that is FDA approved and can be corroborated by hospital documentation * Spinal imaging of the stimulator system
Exclusion criteria
* Current and anticipated need for opioid pain medications or pain that would prevent full participation in the rehabilitation program in the judgment of the principal investigator * Use of botulinum toxin (Botox) injections in the previous six months * Clinically significant mental illness in the judgment of the principal investigator * Other conditions or medications that would make the subject unable to participate in testing/rehabilitation in the judgment of the principal investigator * Nonfunctional spinal cord stimulator or near end-of-life, determined by the PI * Current Pregnancy * Current pain relief from the spinal cord stimulator if the indication for implantation was for management of chronic pain.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Volitional electromyography (EMG) power | 10 years | The measurement of volitional change using EMG during the Brain Motor Control assessment between nonstimulation baseline and stimulation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prediction of power preferences | 10 years | Prediction of power of preference models built based on evaluations of stimulation settings. |
Countries
United States
Contacts
Primary ContactStudy Coordinator
Backup ContactStudy Coordinator
Outcome results
None listed