RESTORES Trial: RESToration Of Rehabilitative Function With Epidural Spinal Stimulation — RS-01  

Chronic Spinal Cord Injury Clinical Trial

Official title: RESTORES Trial: RESToration Of Rehabilitative Function With Epidural Spinal Stimulation

Status Recruiting

Clinical Trial 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 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.

Clinical Trial Description

Motor complete SCI is defined as American Spinal Injury Association (ASIA) impairment Grade A or B, with no motor function preserved below the level of injury. This in-turn results in significant catastrophic dysfunction and disability to the individual's physical and mental health, reducing quality of life and increasing caregiver burden which translates to high socioeconomic costs. The current treatments for chronic SCI involves aggressive rehabilitation to maximize residual neurological function and devices to compensate for neurological loss. However, neurological improvement is dismal, with 94.4% of patients demonstrating no neurological improvement 5-years post-injury. Experimental and electrophysiological observations revealed that spinal networks have the capacity to generate basic locomotor rhythmicity without supraspinal input to the cord. SCS, consisting of a small array of electrodes surgically implanted into the spinal epidural space stimulates afferent sensory pathways in specific patterns to drive voluntary and autonomically controlled motor responses. Activity-based training in conjunction with SCS has been shown to bolster neuroplasticity and recovery caudal to the injury site. The investigators aim to deliver epidural spinal stimulation via an implanted SCS and together with personalized advanced neuro-rehabilitation to study the improvement of neurological function after chronic SCI. ;

Related Conditions & MeSH terms

• Chronic Spinal Cord Injury
• Spinal Cord Injuries

• NCT number: NCT05644171
• Study type: Interventional
• Source: National Neuroscience Institute
• Contact: Kai Rui Wan, MBBS
• Phone: 63577538
• Email: wan.kai.rui@singhealth.com
• Status: Recruiting
• Phase: N/A
• Start date: December 19, 2022
• Completion date: August 30, 2024