We are excited to start the E-STAND clinical trial to assess and optimize epidural spinal cord stimulation to restore volitional movement in chronic, motor-complete paraplegic patients. E-STAND is a multi-site clinical trial. The first site approved for the study is Hennepin County Medical Center in Minneapolis, MN. A subsite at the Minneapolis VA Health Care System is approved for Veterans who participate in this study. The site is run through the Department of Neurosurgery at the University of Minnesota.
Below you will find a table outlining the study with primary, secondary, and exploratory endpoints. We designed the trial to validate the findings of other trials while optimizing stimulation to reduce barriers to future clinical use.
| Objectives:
|
Primary
1. Investigate the use of epidural stimulation to facilitate volitional movement as measured by surface EMG through the Brain Motor Control Assessment (BMCA) Volitional Response Index Magnitude in patients with chronic spinal cord injury and motor paraplegia Secondary 1. Map the parameter space of epidural stimulation using accelerometers to create a Clinical Decision Support System (CDSS) for patient programming 2. Investigate the ability of SCS to enable standing 3. Assess the effect of spinal cord stimulation (SCS) on the cardiovascular system Exploratory 1. Explore the effect of SCS on urinary control 2. Explore psychiatric and quality of life (QOL) endpoints in patients with chronic spinal cord injury undergoing SCS |
| Endpoints | Primary: Lower extremity brain motor control assessment volitional response index magnitude |
| Secondary: | |
| sEMG power generated during standing | |
| Classification of the parameter space | |
| Cardiovascular system endpoints: blood pressure, cardiac function, arterial stiffness | |
| Cerebral autoregulation and associated cognition | |
| Exploratory: | |
| Psychiatric metrics | |
| Quality of Life | |
| Safety: | |
| Physical Examination | |
| Blood Pressure | |
| Adverse Event Incidence | |
| Modified Ashworth Scale Score | |
| Population: | Chronic motor-complete paraplegic patients |
| Phase: | 2 |
| Number of Sites enrolling participants: | 3 |
| Description of Study Agent | St. Jude Medical Tripole™ 16 Lead epidural stimulator paddle, extension wire, and Proclaim™ Elite implantable pulse generator |
| Study Duration: | 5 years |
| Participant Duration: | 15 months |
If you would like to have a patient screened for the study, please complete our prescreening survey.
If you have specific questions about the study or would like to be a part of our team, please contact Dr. David Darrow.