RESTORES Trial: RESToration Of Rehabilitative Function With Epidural Spinal Stimulation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorNational Neuroscience Institute

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • RESToration Of Rehabilitative function with Epidural spinal Stimulation

Treatment groups

18 Participants
are divided into 1 treatment group

Sponsors and collaborators

National Neuroscience Institute

Lead sponsor

Agency for Science, Technology and Research

Collaborator

Tan Tock Seng Hospital

Collaborator