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Clinical Trial NCT05644171 (RS-01) for Chronic Spinal Cord Injury is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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RESTORES Trial: RESToration Of Rehabilitative Function With Epidural Spinal Stimulation (RS-01) 18

Recruiting
Clinical Trial NCT05644171 (RS-01) is an interventional study for Chronic Spinal Cord Injury that is recruiting. It started on 19 December 2022 with plans to enroll 18 participants. Led by National Neuroscience Institute, it is expected to complete by 30 December 2031. The latest data from ClinicalTrials.gov was last updated on 26 January 2026.
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 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 electr...Show More
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 chroni...Show More
Official Title

RESTORES Trial: RESToration Of Rehabilitative Function With Epidural Spinal Stimulation

Conditions
Chronic Spinal Cord Injury
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • RS-01
NCT ID Number
NCT05644171
Start Date (Actual)
2022-12-19
Last Update Posted
2026-01-26
Completion Date (Estimated)
2031-12-30
Enrollment (Estimated)
18
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
Spinal cord injury
Epidural spinal stimulation
Implantation
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
OtherPatients with motor complete chronic spinal cord injury
RESToration Of Rehabilitative function with Epidural spinal Stimulation
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 ...Show More
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime 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 MeasureMeasure DescriptionTime 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
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
21 Years
Eligible Sexes
All

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 Cervical 2 (C2) to Thoracic 12 (T12)
  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

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
National Neuroscience Institute logoNational Neuroscience Institute
  • Agency for Science, Technology and Research logoAgency for Science, Technology and Research
  • Tan Tock Seng Hospital logoTan Tock Seng Hospital
Study Central Contact
Contact: Kai Rui Wan, MBBS, 63577538, [email protected]
1 Study Locations in 1 Countries
National Neuroscience Institute, Singapore, Singapore
Kai Rui Wan, MBBS, Contact, 63577538, [email protected]
Recruiting