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NCT05690074
Monitoring the Effect of Epidural Stimulation on Sensorimotor and Autonomic Functions in Chronic Patients With Spinal Cord Injury
Conditions: Spinal Cord Injuries
Sex: All
Ages: 18 Years – 60 Years
Phase: NA
Enrollment: 5
Sponsor: University Hospital, Motol
Location: Czechia
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.
Eligibility Criteria
Inclusion Criteria:non-progressive SCI with complete motor paralysis below T1; American Spinal Injury Association Impairment Scale (AIS) A or B18 - 60 years of age;longer than 2 years post injury;stable medical conditionunable to voluntarily move all single joints of the legs;spinal cort lesion between C7 and Th10Exclusion 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.
Source: ClinicalTrials.gov (NCT05690074). StuddyBuddy aggregates publicly available trial information.