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RESTORES Trial: RESToration Of Rehabilitative Function With Epidural Spinal Stimulation
Sponsor: National Neuroscience Institute
Summary
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
Key Details
Gender
All
Age Range
21 Years - Any
Study Type
INTERVENTIONAL
Enrollment
18
Start Date
2022-12-19
Completion Date
2031-12-30
Last Updated
2026-01-26
Healthy Volunteers
No
Conditions
Interventions
RESToration Of Rehabilitative function with Epidural spinal Stimulation
15 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.
Locations (1)
National Neuroscience Institute
Singapore, Singapore