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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05644171
Recruitment Status : Recruiting
First Posted : December 9, 2022
Last Update Posted : March 14, 2023
Sponsor:
Collaborators:
Agency for Science, Technology and Research
Tan Tock Seng Hospital
Information provided by (Responsible Party):
National Neuroscience Institute

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Spinal Cord Injury Device: RESToration Of Rehabilitative function with Epidural spinal Stimulation Not Applicable

Detailed 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: RESTORES Trial: RESToration Of Rehabilitative Function With Epidural Spinal Stimulation
Actual Study Start Date : December 19, 2022
Estimated Primary Completion Date : May 30, 2024
Estimated Study Completion Date : August 30, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Patients with motor complete chronic spinal cord injury Device: RESToration Of Rehabilitative function with Epidural spinal Stimulation
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.


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with treatment-related adverse events assessed by CTCAE v5.0 [ Time Frame: 6 months ]
    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.


Secondary Outcome Measures :
  1. Assessing the improvement in motor outcomes post surgical implantation [ Time Frame: 2 years ]

    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. Assessing autonomic function post surgical implantation [ Time Frame: 2 years ]
    The improvement in hemodynamic, bowel and bladder control with epidural spinal stimulation and robotic neuro-rehabilitation will be assessed continuously post surgical implantation


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

⦁ Inclusion Criteria

For inclusion in the study, the potential patient has to fulfil all of the following criteria:

  1. 21 years old and older
  2. Chronic (greater than one year) motor complete (AIS classification A or B) SCI
  3. Spinal injury between the levels of Thoracic 2 (T2) to Lumbar 1 (L1)
  4. Segmental reflexes that remain functional below the level of lesion

  5. 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:

  1. Significant medical co-morbidities that would significantly increase the risk of the operation
  2. Severe dysautonomia with systolic blood pressure fluctuation less than 50 or more than 200mmHg on tilt table testing
  3. Painful musculoskeletal dysfunction, contractures, unhealed fractures, pressure sores, severe spasticity, and osteoporosis
  4. Significant psychological issues or ongoing drug abuse
  5. Pregnancy and lactating patients
  6. Progressive spinal cord disease
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05644171


Contacts
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Contact: Kai Rui Wan, MBBS 63577538 wan.kai.rui@singhealth.com

Locations
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Singapore
National Neuroscience Institute Recruiting
Singapore, Singapore
Contact: Kai Rui Wan, MBBS    63577538    wan.kai.rui@singhealth.com   
Sponsors and Collaborators
National Neuroscience Institute
Agency for Science, Technology and Research
Tan Tock Seng Hospital
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

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Responsible Party: National Neuroscience Institute
ClinicalTrials.gov Identifier: NCT05644171    
Other Study ID Numbers: RS-01
First Posted: December 9, 2022    Key Record Dates
Last Update Posted: March 14, 2023
Last Verified: March 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Neuroscience Institute:
Spinal cord injury
Epidural spinal stimulation
Implantation
Additional relevant MeSH terms:
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Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
 Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries