RESTORES Trial: RESToration Of Rehabilitative Function With Epidural Spinal Stimulation
National Neuroscience Institute
18 participants
Dec 19, 2022
INTERVENTIONAL
Conditions
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
Eligibility
Inclusion Criteria6
- For inclusion in the study, the potential patient has to fulfil all of the following criteria:
- 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
- Able to perform the perioperative rehabilitation program as judged by the research team
Exclusion Criteria7
- Potential 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 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
- Pregnancy and lactating patients
- Progressive spinal cord disease
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Interventions
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)
View Full Details on ClinicalTrials.gov
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NCT05644171