Epidural Stimulation in Chronic Spinal Cord Injury Patients

University Hospital, Motol

Status

Enrolling

Conditions

Spinal Cord Injuries

Treatments

Device: Spectra Wave Writer™ Spinal Cord Stimulator System

Study type

Interventional

Funder types

Other

Identifiers

NCT05690074

EK-1302/21

Details and patient eligibility

About

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.

Enrollment

5 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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.