This study will evaluate a method to optimize parameter settings in epidural spinal cord stimulation used to recover lower extremity volitional movement. The study will also characterize improvement in autonomic function (such as blood pressure control) and other functions related to spinal cord injury.
Epidural spinal cord stimulation for the purpose of facilitating volitional movement is a new and novel neuromodulatory treatment. Epidural SCS has a long history of use for chronic pain with established medical device platforms. The purpose of this study is to investigate and establish the use of SCS for volitional movement. Specifically, establishing the disinhibitory effect of SCS in a greater population with inherent greater variability. In addition to establishing the disinhibitory effect of SCS for cSCI, our study attempts to explore the parameter space of the spinal cord stimulator platforms in order to optimize stimulation settings for patients through the creation of a clinical decision support system (CDSS). Preliminary evidence suggests benefit to autonomic function, and this study also begins to explore the effects of SCS on cardiovascular function, urinary function, psychiatric outcomes, and quality of life, which all offer significant potential for patients suffering from chronic spinal cord injury.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
epidural spinal cord stimulator
Hennepin County Medical Center
Minneapolis, Minnesota, United States
RECRUITINGChange in Volitional Response Index Magnitude
Brain Motor Control Assessment Volitional Response Index Magnitude
Time frame: Months: 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15
Spinal cord stimulation for cardiovascular function
Systolic blood pressure measured during epidural stimulation (continuous)
Time frame: Over 12 months
Cerebrovascular Assessment Change
Cerebral blood flow (CBF) during tilt table
Time frame: Months: 3, 6, 9
Change in Visual Neurocognitive Assessment
Stroop Test
Time frame: Months: 3, 6, 9
Spinal cord stimulation optimization
Probit preference response surface obtained by serial force binary choice
Time frame: Over 12 months
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