Investigators propose to demonstrate that epidural stimulation (ES) can be used to recover significant levels of autonomic control of cardiovascular, urinary and sexual function as well as the ability to voluntarily control leg movements below the injury level. This intervention would provide an immediate therapeutic alternative to individuals who now have no recourse for treatment. In addition investigators suggest to prove on functional magnetic resonance imaging if there are some significant changes before and after the stimulation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
Device: 5-6-5 Specify electrode Device: Restore Advance Pulse Generator
UH Motol
Prague, Czechia
RECRUITINGBrain functional connectivity
Researchers want to describe if there are some changes on functional MRI of the spinal cord and brain before and after stimulation. With functional MRI in rest and task condition, the functional connectivity (FC) is examined.
Time frame: 1 year after implantation
Change from baseline of lower extremity independence time during after 1 year of stimulation
Researchers will measure the amount of time individuals are able to stand without manual assistance (independently).
Time frame: 1 year after stimulation (360 training sessions)
Change in trunk stability restoration
Trunk control stability test in individuals with spinal cord injury (SCI)
Time frame: 6 month and 1 year after implantation
Neurogenic bladder symptoms will be measured using the Neurogenic Bladder Symptom Score (NBSS).
Assessment of neurogenic bladder symptoms will be performed to assess the impact of long term eSCS on this measure. The score measures bladder symptoms across 3 different domains: incontinence (scored 0-29), storage and voiding (scored 0-22), and consequences (scored 0-23), with higher scores representing worse symptoms.
Time frame: 3 month, 6 month, 9 month, 12 month
Sexual function as measured by the Sexual Function Questionnaire
The Sexual Function Questionnaire (SFQ) is a self-report outcome measure of sexual function.
Time frame: 3 month, 6 month, 9 month, 12 month
Change in sense of wellbeing as measured by the World Health Organization Quality of Life (WHOQOL-BREF) questionnaire
The WHOQOL-BREF assesses quality of life (QOL) within the context of an individual's culture, value systems, personal goals, standards and concerns. The higher score in the questionnaire means better quality of life for patient.
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Time frame: 3 month, 6 month, 9 month, 12 month
Symptoms of spasticity will be measured by Modified Ashworth spasticity test
The modified Ashworth scale is the most universally accepted clinical tool used to measure the increase of muscle tone.
Time frame: 3 month, 6 month, 9 month, 12 month
Neurogenic bowel symptoms will be measured using the Neurogenic Bowel Dysfunction (NBD) score.
Assessment of neurogenic bowel symptoms will be performed to assess the impact of long term eSCS on this measure. Scores can range from 0-47, with a higher score representing more severe dysfunction.
Time frame: 3 month, 6 month, 9 month, 12 month
Reduction of neuropathic pain
We will measure neuropathic pain by the Neuropathic Pain Questionnaire (NPQ)
Time frame: 3 month, 6 month, 9 month, 12 month
Change in BP during the head up tilt test (HUTT)
During HUTT, participants will be passively moved to approximately 60° upright stand position by the investigators using the tilt table. Using epidural spinal cord stimulation (eSCS) to activate spinal sympathetic circuitry and mitigate low resting BP and orthostatic hypotension (OH) and continuous beat-by beat BP monitoring via finger photoplethysmography.
Time frame: 6 month -1 year