RESTORES Trial: RESToration Of Rehabilitative Function With Epidural Spinal Stimulation

Spinal Cord Injury (SCI), being a devastating diagnosis, has little to no recovery which leads to a long-standing of debilitating impairment for affected patients. The National Neuroscience Institute (NNI) Neurosurgery team, together with our collaborators, will be embarking on a new clinical pilot trial named RESTORES: RESToration of Rehabilitative function with Epidural Spinal Stimulation. This study aims to investigate the feasibility of electrical stimulation via a spinal cord stimulator (SCS), which will be implanted into the study subjects, and advanced robotic neuro-rehabilitation to aid in improving neurological function in patients diagnosed with chronic SCI. A total of 3 patients, male and female participants, above the age of 21 who have been diagnosed with the condition for more than a year will be recruited for this study over a 2-year period. Rehab sessions will take place pre and post-surgical implant, assessing subject improvements.

⦁ Inclusion CriteriaFor inclusion in the study, the potential patient has to fulfil all of the following criteria:21 years old and olderChronic (greater than one year) motor complete (AIS classification A or B) SCISpinal injury between the levels of Thoracic 2 (T2) to Lumbar 1 (L1)Segmental reflexes that remain functional below the level of lesionAble to perform the perioperative rehabilitation program as judged by the research teamExclusion CriteriaPotential 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 operationSevere dysautonomia with systolic blood pressure fluctuation less than 50 or more than 200mmHg on tilt table testingPainful musculoskeletal dysfunction, contractures, unhealed fractures, pressure sores, severe spasticity, and osteoporosisSignificant psychological issues or ongoing drug abusePregnancy and lactating patientsProgressive spinal cord disease