Monitoring the Effect of Epidural Stimulation on Sensorimotor and Autonomic Functions in Chronic Patients With Spinal Cord Injury
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Spinal Cord Injuries
- Sponsor
- University Hospital, Motol
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- Brain functional connectivity
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Investigators
Vojtech Rybka, MD
Principal Investigator
University Hospital, Motol
Eligibility Criteria
Inclusion Criteria
- •non-progressive SCI with complete motor paralysis below T1; American Spinal Injury Association Impairment Scale (AIS) A or B
- •18 - 60 years of age;
- •longer than 2 years post injury;
- •stable medical condition
- •unable to voluntarily move all single joints of the legs;
- •spinal cort lesion between C7 and Th10
Exclusion Criteria
- •ventilator dependent;
- •painful musculoskeletal dysfunction, unhealed fracture, contracture, or pressure sore that might interfere with training;
- •clinically significant depression or ongoing drug abuse;
- •cardiovascular, respiratory, bladder, or renal disease unrelated to SCI;
- •severe anemia (Hgb\<8 g/dl) or hypovolemia; and HIV or AIDS related illness.
Outcomes
Primary Outcomes
Brain functional connectivity
Time Frame: 1 year after implantation
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.
Change from baseline of lower extremity independence time during after 1 year of stimulation
Time Frame: 1 year after stimulation (360 training sessions)
Researchers will measure the amount of time individuals are able to stand without manual assistance (independently).
Secondary Outcomes
- Change in sense of wellbeing as measured by the World Health Organization Quality of Life (WHOQOL-BREF) questionnaire(3 month, 6 month, 9 month, 12 month)
- Change in trunk stability restoration(6 month and 1 year after implantation)
- Neurogenic bowel symptoms will be measured using the Neurogenic Bowel Dysfunction (NBD) score.(3 month, 6 month, 9 month, 12 month)
- Reduction of neuropathic pain(3 month, 6 month, 9 month, 12 month)
- Sexual function as measured by the Sexual Function Questionnaire(3 month, 6 month, 9 month, 12 month)
- Neurogenic bladder symptoms will be measured using the Neurogenic Bladder Symptom Score (NBSS).(3 month, 6 month, 9 month, 12 month)
- Symptoms of spasticity will be measured by Modified Ashworth spasticity test(3 month, 6 month, 9 month, 12 month)
- Change in BP during the head up tilt test (HUTT)(6 month -1 year)