NCT05644171

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 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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
69mo left

Started Dec 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress37%
Dec 2022Dec 2031

First Submitted

Initial submission to the registry

October 30, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 9, 2022

Completed
10 days until next milestone

Study Start

First participant enrolled

December 19, 2022

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2030

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2031

Last Updated

January 26, 2026

Status Verified

January 1, 2026

Enrollment Period

8 years

First QC Date

October 30, 2022

Last Update Submit

January 23, 2026

Conditions

Chronic Spinal Cord Injury

Keywords

Spinal cord injuryEpidural spinal stimulationImplantation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Assessing the improvement in motor outcomes post surgical implantation

    2 years

  • Assessing autonomic function post surgical implantation

    2 years

Study Arms (1)

Patients with motor complete chronic spinal cord injury

OTHER
Device: RESToration Of Rehabilitative function with Epidural spinal Stimulation

Interventions

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.

Patients with motor complete chronic spinal cord injury

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Neuroscience Institute

Singapore, Singapore

RECRUITING

Related Publications (6)

  • 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.

    PMID: 15520976BACKGROUND

  • Minassian 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.

    PMID: 15124000BACKGROUND

  • Lim 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.

    PMID: 17285186BACKGROUND

  • Minassian 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.

    PMID: 17343947BACKGROUND

  • Teo 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.

    PMID: 21091048BACKGROUND

  • Wee 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.

    PMID: 40568376DERIVED

Related Links

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Central Study Contacts

Kai Rui Wan, MBBS

CONTACT

63577538wan.kai.rui@singhealth.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2022

First Posted

December 9, 2022

Study Start

December 19, 2022

Primary Completion (Estimated)

December 30, 2030

Study Completion (Estimated)

December 30, 2031

Last Updated

January 26, 2026

Record last verified: 2026-01

Locations

SG(1)