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 NNI Neurosurgery team, together with our collaborators, are expanding our recruitment from our 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 neurorehabilitation to aid in improving neurological function in patients diagnosed with chronic SCI. An additional 15 patients on top of the 3 ongoing 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
21 years old and older
Chronic (greater than one year) motor complete (AIS classification A or B) SCI
Spinal injury between the levels of Cervical 2 (C2) to Thoracic 12 (T12)
Segmental reflexes that remain functional below the level of lesion
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
Single group
RESToration Of Rehabilitative function with Epidural spinal Stimulation
Device15 patients with chronic motor SCI will be recruited in total for this study. The recruited patients will not be randomized nor blinded due to the nature of this study. Pre-op rehabilitation session will take place over 4 weeks. 1 month post-surgical implants, patients will undergo 24 weeks of rehabilitation. The training sessions may continue to take place after the stipulated 24 weeks as long the electrode remains implanted, and the patient is available.
Number of participants with treatment-related adverse events assessed by CTCAE v5.0
The adverse events in patient's with proposed surgical implantation and robotic neuro-rehabilitation during the course of study will be assessed. Particularly, during the first 6 months of the study and post implantation.
Assessing the improvement in motor outcomes post surgical implantation
Volitional control including independent locomotion with epidural spinal stimulation and robotic neuro-rehabilitation will be assessed to check for improvement in motor functions. This assessment will be done during rehabilitation session where the post-surgical movement results will be compared against the pre-surgical results for better understanding and study.
Assessing autonomic function post surgical implantation
The improvement in hemodynamic, bowel and bladder control with epidural spinal stimulation and robotic neuro-rehabilitation will be assessed continuously post surgical implantation
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National Neuroscience Institute
Lead sponsor
Agency for Science, Technology and Research
Collaborator
Tan Tock Seng Hospital
Collaborator
