Transcutaneous Spinal Cord Stimulation With Robotic Gait Training in Chronic SCI

NCT05921175 | Recruiting

• 1 other identifier: 2023/00350 & 2024/4401
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

This study is aimed to evaluate whether transcutaneous spinal cord stimulation (tSCS) can augment robotic gait training (RGT) to improve functional mobility in participants with chronic spinal cord injuries. It also evaluate the impact of the tSCS+RGT on health-related quality of life (HRQOL), compared to RGT alone. This is a prospective single-arm crossover study in participants with incomplete chronic traumatic spinal cord injury. 6 subjects with paraplegia and 6 subjects with tetraplegia will be recruited. The intervention includes Phase 1 of training which consists of 16 sessions of robotic gait training (RGT) + conventional physiotherapy in 8-10 weeks, and Phase 2 of training which consists of 16 sessions of RGT training + tSCS + conventional physiotherapy in 8-10 weeks. Outcome measures including mobility function assessment and neuromuscular assessment will be collected at Baseline, Post-Phase 1 and Post-Phase 2. A satisfaction survey on the intervention "RGT training + tSCS + conventional physiotherapy" will be performed at week-18 assessment.

Conditions

Spinal Cord Injury

Keywords

spinal cord injury; transcutaneous spinal cord stimulation; robotic gait training

Outcome Measures

Primary Outcomes (15)

• Spinal Cord Injury - Trunk Control Test (SCI-TCT)

  It measures 4 simple aspect of trunk movement: 1) rolling to weak side; 2) rolling to strong side; 3) balance in sitting position; 4) sit up from lying down. The final score ranges from 0 (minimum) to 100 (maximum, indicating better performance)

  Week 0

• Spinal Cord Injury - Trunk Control Test (SCI-TCT)

  It measures 4 simple aspect of trunk movement: 1) rolling to weak side; 2) rolling to strong side; 3) balance in sitting position; 4) sit up from lying down. The final score ranges from 0 (minimum) to 100 (maximum, indicating better performance)

  Week 8

• Spinal Cord Injury - Trunk Control Test (SCI-TCT)

  It measures 4 simple aspect of trunk movement: 1) rolling to weak side; 2) rolling to strong side; 3) balance in sitting position; 4) sit up from lying down. The final score ranges from 0 (minimum) to 100 (maximum, indicating better performance)

  Week 17

• Walking Index in Spinal Cord Injury-II (WISCI-II)

  It is an ordinal scale of 20 items assessing the amount of physical assistance needed, as well as device required, for walking following paralysis that results from spinal cord injury. Final score ranges from 0 (minimum) to 20 (maximum, indicating better performance).

  Week 0

• Walking Index in Spinal Cord Injury-II (WISCI-II)

  It is an ordinal scale of 20 items assessing the amount of physical assistance needed, as well as device required, for walking following paralysis that results from spinal cord injury. Final score ranges from 0 (minimum) to 20 (maximum, indicating better performance).

  Week 8

• Walking Index in Spinal Cord Injury-II (WISCI-II)

  It is an ordinal scale of 20 items assessing the amount of physical assistance needed, as well as device required, for walking following paralysis that results from spinal cord injury. Final score ranges from 0 (minimum) to 20 (maximum, indicating better performance).

  Week 17

• 10-Meter Walk Test (10MWT)

  It measures walking speed when subject walks at comfortable speed, covered in the distance of 10 meters. Higher result indicates higher walking speed/better performance.

  Week 0

• 10-Meter Walk Test (10MWT)

  It measures walking speed when subject walks at comfortable speed, covered in the distance of 10 meters. Higher result indicates higher walking speed/better performance.

  Week 8

• 10-Meter Walk Test (10MWT)

  It measures walking speed when subject walks at comfortable speed, covered in the distance of 10 meters. Higher result indicates higher walking speed/better performance.

  Week 17

• Central motor conduction time (CMCT)

  Measured by transcranial magnetic stimulation (TMS). It is calculated by subtracting the peripheral conduction time (PMCT) from motor evoked potential (MEP) latency elicited by TMS to the motor cortex. Higher results indicates longer central motor conduction time and poor performance.

  Week 0

• Central motor conduction time (CMCT)

  Measured by transcranial magnetic stimulation (TMS). It is calculated by subtracting the peripheral conduction time (PMCT) from motor evoked potential (MEP) latency elicited by TMS to the motor cortex. Higher results indicates longer central motor conduction time and poor performance.

  Week 8

• Central motor conduction time (CMCT)

  Measured by transcranial magnetic stimulation (TMS). It is calculated by subtracting the peripheral conduction time (PMCT) from motor evoked potential (MEP) latency elicited by TMS to the motor cortex. Higher results indicates longer central motor conduction time and poor performance.

  Week 17

• International standards for Neurological Classification of SCI (ISNCSCI)

  The test is to define and describe the extent and severity of a patient's spinal cord injury. The patient's grade is based on how much sensation he or she can feel at multiple points on the body, as well as tests of motor function. The results ranged from A (worst- complete lack of motor and sensory function below the level of injury) to E (best, all neurologic function has returned)

  Week 0

• International standards for Neurological Classification of SCI (ISNCSCI)

  The test is to define and describe the extent and severity of a patient's spinal cord injury. The patient's grade is based on how much sensation he or she can feel at multiple points on the body, as well as tests of motor function. The results ranged from A (worst- complete lack of motor and sensory function below the level of injury) to E (best, all neurologic function has returned)

  Week 8

• International standards for Neurological Classification of SCI (ISNCSCI)

  The test is to define and describe the extent and severity of a patient's spinal cord injury. The patient's grade is based on how much sensation he or she can feel at multiple points on the body, as well as tests of motor function. The results ranged from A (worst- complete lack of motor and sensory function below the level of injury) to E (best, all neurologic function has returned)

  Week 17

Secondary Outcomes (9)

• EQ5D

  Week 0

• EQ5D

  Week 8

• EQ5D

  Week 17

• Modified Tardieu Scale

  Week 0

• Modified Tardieu Scale

  Week 8

Study Arms (2)

RGT+ conventional physiotherapy

ACTIVE COMPARATOR

16 sessions of robotic gait training (RGT) + conventional physiotherapy in 8-10 weeks

Device: RGT+ conventional physiotherapy

RGT+ tSCS + conventional physiotherapy

EXPERIMENTAL

Phase 2: 16 sessions of RGT training + transcutaneous electrical stimulation (tSCS) + functional training in 8-10 weeks.

Device: RGT+ tSCS + conventional physiotherap

Interventions

RGT+ tSCS + conventional physiotherap DEVICE

Subject will undergo 16 sessions of robotic gait training (RGT) + tSCS+ conventional physiotherapy in 8-10 weeks. Subject will walk with EksoGT for gait training during RGT training. Components of conventional physiotherapy will include upper/lower limb ergometry and strength training as prescribed by the attending physiotherapist based on their assessment. During tSCS, cathodes will be placed on the T11 and L1 spinous process. Reference/Ground electrodes placed over the ASIS It will be on biphasic mode with an overlap frequency of 10kHz, Burst Frequency of 30Hz, Pulse width of 1ms. Stimulation intensity ranges from 5-100 mA and will be adjusted according to the patient's response. The tSCS stimulation duration for each session will be 45 minutes in conjunction with the RGT training.

RGT+ tSCS + conventional physiotherapy

RGT+ conventional physiotherapy DEVICE

Subject will undergo 16 sessions of robotic gait training (RGT) + conventional physiotherapy in 8-10 weeks. Subject will walk with EksoGT for gait training during RGT training. Components of conventional physiotherapy will include upper/lower limb ergometry and strength training as prescribed by the attending physiotherapist based on their assessment.

RGT+ conventional physiotherapy

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between 6 months to 5 years from the diagnosis of the traumatic SCI and who are not walking independently;
• Age between 21 to 65 years old;
• Incomplete spinal cord injury: ASIA Impairment Scale (AIS) Grade: B-D;
• Spinal cord injury level: T1- L1, or C2-C8;
• SCI-TCT Score \> 13;
• Capable of providing an informed consent;
• Cleared by Neurosurgeons/ Orthopeadic Surgeons for tSCS;
• Meets prerequisites for Ekso wearable robotic exoskeleton training.

You may not qualify if:

• Participant has uncontrolled cardiopulmonary disease or cardiac symptoms as determined by the investigator;
• Participant has any unstable or significant medical condition that is likely to interfere with study procedures or likely to confound performance and outcomes like uncontrolled neuropathic pain, depression, severe cognitive impairment;
• Unstable or uncontrolled autonomic dysreflexia;
• Requires ventilator support;
• Spasms that limit the ability of the subjects to participate in the study training as determined by the investigator;
• Skin conditions that limit the application of tSCS electrodes;
• Active implanted medical devices that may be affected by tSCS;
• Pregnant, planning to become pregnant or breastfeeding;
• Concurrent participation in another drug or device trial that may interfere with this study;
• Participated in wearable exoskeleton training within the last 3 months prior to enrolment.
• Peripheral nerve injury or significant Lumbar Radiculopathy

Sponsors & Collaborators

• National University Hospital, Singapore: lead
• Alexandra Hospital: collaborator

Study Sites (1)

Alexandra Hospital

Singapore, Singapore, 159964, Singapore

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Gobinathan Chandran, MBBS

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gobinathan Chandran, MBBS

CONTACT

(65) 94575924; Gobinathan_CHANDRAN@nuhs.edu.sg

Ning Tang, PhD

CONTACT

ning_tang@nuhs.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective single-arm crossover study in participants with incomplete chronic traumatic spinal cord injury.

Study Record Dates

• First Submitted: June 19, 2023
• First Posted: June 27, 2023
• Study Start: November 13, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: February 23, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)