RESTORES Trial: RESToration Of Rehabilitative Function With Epidural Spinal Stimulation (RS-01)
Chronic Spinal Cord Injury
About this trial
This is an interventional treatment trial for Chronic Spinal Cord Injury focused on measuring Spinal cord injury, Epidural spinal stimulation, Implantation
Eligibility Criteria
⦁ Inclusion Criteria For inclusion in the study, the potential patient has to fulfil all of the following criteria: 21 years old and older Chronic (greater than one year) motor complete (AIS classification A or B) SCI Spinal injury between the levels of Thoracic 2 (T2) to Lumbar 1 (L1) Segmental reflexes that remain functional below the level of lesion Able to perform the perioperative rehabilitation program as judged by the research team Exclusion Criteria Potential patients will be excluded from the trial if they fulfil any of the following criteria: Significant medical co-morbidities that would significantly increase the risk of the operation Severe dysautonomia with systolic blood pressure fluctuation less than 50 or more than 200mmHg on tilt table testing Painful musculoskeletal dysfunction, contractures, unhealed fractures, pressure sores, severe spasticity, and osteoporosis Significant psychological issues or ongoing drug abuse Pregnancy and lactating patients Progressive spinal cord disease
Sites / Locations
- National Neuroscience InstituteRecruiting
Arms of the Study
Arm 1
Other
Patients with motor complete chronic spinal cord injury