RESTORES Trial: RESToration Of Rehabilitative Function With Epidural Spinal Stimulation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Chronic Spinal Cord Injury

Intervention / Treatment
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* Device: RESToration Of Rehabilitative function with Epidural spinal Stimulation


Participation Criteria
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Eligibility Criteria
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⦁ Inclusion Criteria 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 Thoracic 2 (T2) to Lumbar 1 (L1) Segmental reflexes that remain functional below the level of lesion Able to perform the perioperative rehabilitation program as judged by the research team Exclusion Criteria 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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patients with motor complete chronic spinal cord injury<br> | Device: RESToration Of Rehabilitative function with Epidural spinal Stimulation<br>* Three 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 years | 
| 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 | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spinal cord injury, Epidural spinal stimulation, Implantation