Chronic Spinal Cord InjuryRS-01NCT05644171
RESTORES Trial: RESToration Of Rehabilitative Function With Epidural Spinal Stimulation
A study testing RESToration Of Rehabilitative function with Epidural spinal Stimulation in people with Chronic Spinal Cord Injury, run by National Neuroscience Institute at 1 site in Singapore.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Chronic Spinal Cord Injury
- What is being tested?
- RESToration Of Rehabilitative function with Epidural spinal Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteSingapore
- Study dates
- 19 Dec 2022to 30 Dec 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site, 1 recruiting
- Recruiting
National Neuroscience Institute
Singapore
Kai Rui Wan, MBBS, 63577538, wan.kai.rui@singhealth.com
About this study
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
Read the 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 hide 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 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. We 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.
- Conditions
- Chronic Spinal Cord Injury
- Being tested
- RESToration Of Rehabilitative function with Epidural spinal Stimulation
- Keywords
- Spinal cord injury, Epidural spinal stimulation, Implantation
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RESToration Of Rehabilitative function with Epidural spinal StimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with motor complete chronic spinal cord injury | Other | Not described Receives: Device: RESToration Of Rehabilitative function with Epidural spinal Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (2)
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.
Measured: 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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start19 Dec 2022
- Primary completion30 Dec 2030 (estimated)
- Study completion30 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Chronic Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Neuroscience Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Science, Technology and Research, Tan Tock Seng Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05644171
- Sponsor's protocol ID
- RS-01
- Acronym
- RS-01
- Status last verified
- Jan 2026
- First submitted
- 30 Oct 2022
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kirshblum S, Millis S, McKinley W, Tulsky D. Late neurologic recovery after traumatic spinal cord injury. Arch Phys Med Rehabil. 2004 Nov;85(11):1811-7. doi: 10.1016/j.apmr.2004.03.015.
PubMed 15520976Minassian K, Jilge B, Rattay F, Pinter MM, Binder H, Gerstenbrand F, Dimitrijevic MR. Stepping-like movements in humans with complete spinal cord injury induced by epidural stimulation of the lumbar cord: electromyographic study of compound muscle action potentials. Spinal Cord. 2004 Jul;42(7):401-16. doi: 10.1038/sj.sc.3101615.
PubMed 15124000Lim PA, Tow AM. Recovery and regeneration after spinal cord injury: a review and summary of recent literature. Ann Acad Med Singap. 2007 Jan;36(1):49-57.
PubMed 17285186Minassian K, Persy I, Rattay F, Pinter MM, Kern H, Dimitrijevic MR. Human lumbar cord circuitries can be activated by extrinsic tonic input to generate locomotor-like activity. Hum Mov Sci. 2007 Apr;26(2):275-95. doi: 10.1016/j.humov.2007.01.005. Epub 2007 Mar 6.
PubMed 17343947Teo SH, Sew S, Backman C, Forwell S, Lee WK, Chan PL, Dean E. Health of people with spinal cord injury in Singapore: implications for rehabilitation planning and implementation. Disabil Rehabil. 2011;33(15-16):1460-74. doi: 10.3109/09638288.2010.533812. Epub 2010 Nov 20.
PubMed 21091048Wan KR, Ng ZYV, Wee SK, Misbaah F, Lui WL, Phua MW, Plunkett T, Robinson N, Phyo Wai AA, Guan C, Sidarta A, So RQY, Premchand B, Susanto K, Cocchi L, Saffari SE, Ker RXJ, Ng WH. Effect of epidural spinal cord stimulation combined with personalized neurorehabilitation in chronic motor-complete spinal cord injury: study protocol for the phase II single-arm feasibility RESTORES (RESToration Of Rehabilitative function with Epidural spinal Stimulation) trial. Front Neurol. 2026 Oct 9;17:1967078. doi: 10.3389/fneur.2026.1967078. eCollection 2026.
PubMed 42921395Wee SK, Valerie ZYN, Phua MW, Lui WL, Misbaah F, Ker RXJ, Ng WH, Rui Wan K. Synergistic integration of epidural spinal cord stimulation with robotic therapy and neurorehabilitation to facilitate functional recovery in chronic sensorimotor complete spinal cord injury: A case series. Adv Rehabil Sci Pract. 2025 Jun 24;14:27536351251343738. doi: 10.1177/27536351251343738. eCollection 2025 Jan-Dec.
PubMed 40568376
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RESTORES Trial: RESToration Of Rehabilitative Function With Epidural Spinal Stimulation
- ClinicalTrials.gov ID
- NCT05644171
- Acronym / sponsor ID
- RS-01 / RS-01
- Conditions
- Chronic Spinal Cord Injury
- Keywords
- Spinal cord injury, Epidural spinal stimulation, Implantation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- National Neuroscience InstituteUniversity, hospital or other
- Collaborators
- Agency for Science, Technology and Research, Tan Tock Seng Hospital
- Study start
- 19 Dec 2022 (actual)
- Primary completion
- 30 Dec 2030 (estimated)
- Study completion
- 30 Dec 2031 (estimated)
- First posted
- 9 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 hide 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 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. We 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with motor complete chronic spinal cord injury | Other | Device: RESToration Of Rehabilitative function with Epidural spinal Stimulation |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RESToration Of Rehabilitative function with Epidural spinal Stimulation15 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. | Device | Patients with motor complete chronic spinal cord injury |
Primary outcome
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.
2 secondary outcomes
Assessing the improvement in motor outcomes post surgical implantation
Time frame: 2 years
Assessing autonomic function post surgical implantation
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Background: PubMed 15520976Kirshblum S, Millis S, McKinley W, Tulsky D. Late neurologic recovery after traumatic spinal cord injury. Arch Phys Med Rehabil. 2004 Nov;85(11):1811-7. doi: 10.1016/j.apmr.2004.03.015.
- Background: PubMed 15124000Minassian K, Jilge B, Rattay F, Pinter MM, Binder H, Gerstenbrand F, Dimitrijevic MR. Stepping-like movements in humans with complete spinal cord injury induced by epidural stimulation of the lumbar cord: electromyographic study of compound muscle action potentials. Spinal Cord. 2004 Jul;42(7):401-16. doi: 10.1038/sj.sc.3101615.
- Background: PubMed 17285186Lim PA, Tow AM. Recovery and regeneration after spinal cord injury: a review and summary of recent literature. Ann Acad Med Singap. 2007 Jan;36(1):49-57.
- Background: PubMed 17343947Minassian K, Persy I, Rattay F, Pinter MM, Kern H, Dimitrijevic MR. Human lumbar cord circuitries can be activated by extrinsic tonic input to generate locomotor-like activity. Hum Mov Sci. 2007 Apr;26(2):275-95. doi: 10.1016/j.humov.2007.01.005. Epub 2007 Mar 6.
- Background: PubMed 21091048Teo SH, Sew S, Backman C, Forwell S, Lee WK, Chan PL, Dean E. Health of people with spinal cord injury in Singapore: implications for rehabilitation planning and implementation. Disabil Rehabil. 2011;33(15-16):1460-74. doi: 10.3109/09638288.2010.533812. Epub 2010 Nov 20.
- Derived from this study: PubMed 42921395Wan KR, Ng ZYV, Wee SK, Misbaah F, Lui WL, Phua MW, Plunkett T, Robinson N, Phyo Wai AA, Guan C, Sidarta A, So RQY, Premchand B, Susanto K, Cocchi L, Saffari SE, Ker RXJ, Ng WH. Effect of epidural spinal cord stimulation combined with personalized neurorehabilitation in chronic motor-complete spinal cord injury: study protocol for the phase II single-arm feasibility RESTORES (RESToration Of Rehabilitative function with Epidural spinal Stimulation) trial. Front Neurol. 2026 Oct 9;17:1967078. doi: 10.3389/fneur.2026.1967078. eCollection 2026.
- Derived from this study: PubMed 40568376Wee SK, Valerie ZYN, Phua MW, Lui WL, Misbaah F, Ker RXJ, Ng WH, Rui Wan K. Synergistic integration of epidural spinal cord stimulation with robotic therapy and neurorehabilitation to facilitate functional recovery in chronic sensorimotor complete spinal cord injury: A case series. Adv Rehabil Sci Pract. 2025 Jun 24;14:27536351251343738. doi: 10.1177/27536351251343738. eCollection 2025 Jan-Dec.
- Recruitment Challenges in Spinal Cord Stimulation Trial for Motor Recovery in Patients with Chronic Complete Spinal Cord InjuryLink provided by the sponsor.
- Synergistic integration of epidural spinal cord stimulation with robotic therapy and neurorehabilitation to facilitate functional recovery in chronic sensorimotor complete spinal cord injury: A case seriesLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RESToration Of Rehabilitative function with Epidural spinal Stimulation in people with Chronic Spinal Cord Injury, run by National Neuroscience Institute at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kai Rui Wan, MBBS (63577538, wan.kai.rui@singhealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events assessed by CTCAE v5.0 (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05644171, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.