tSCS + EksoGT in SCI Patients

NCT ID: NCT05921175

Last Updated: 2024-08-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-30
• Study Completion Date: 2026-09-30

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 paraplegia. 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 paraplegia. 6 subjects 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.

Detailed Description

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 paraplegia. 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 paraplegia. 6 subjects will be recruited. Once subject is identified to be eligible for the study and is agreeable to participate into the study, he/she will undergo Phase 1 of training which consists of 16 sessions of robotic gait training (RGT) + conventional physiotherapy in 8-10 weeks. After a 1-week washout period, subject will undergo Phase 2 of training which consists of 16 sessions of RGT training + 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.

Outcome measures including mobility function assessment and neuromuscular assessment will be collected at Baseline (within 1 week before the starting of Phase 1 of training), Post-Phase 1 (within 1 week after Phase 1 of training) and Post-Phase 2 (within 1 week after Phase 2 of training).

A satisfaction survey on the intervention "RGT training + tSCS + conventional physiotherapy" will be performed at week-18 assessment.

Conditions

Spinal Cord Injury

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RGT+ conventional physiotherapy

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

Group Type: ACTIVE_COMPARATOR

RGT+ conventional physiotherapy

Intervention Type: 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+ tSCS + conventional physiotherapy

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

Group Type: EXPERIMENTAL

RGT+ tSCS + conventional physiotherap

Intervention Type: 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.

Interventions

RGT+ tSCS + conventional physiotherap

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.

Intervention Type: DEVICE

RGT+ conventional physiotherapy

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Between 6 months to 5 years from the diagnosis of the traumatic SCI and who are not walking independently;

2. Age between 21 to 65 years old;

3. Incomplete spinal cord injury: ASIA Impairment Scale (AIS) Grade: B-D;

4. Spinal cord injury level: T1- L1;

5. SCI-TCT Score > 13;

6. Capable of providing an informed consent;

7. Cleared by Neurosurgeons/ Orthopeadic Surgeons for tSCS;

8. Meets prerequisites for Ekso wearable robotic exoskeleton training.

Exclusion Criteria

1. Participant has uncontrolled cardiopulmonary disease or cardiac symptoms as determined by the investigator;

2. 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;

3. Unstable or uncontrolled autonomic dysreflexia;

4. Requires ventilator support;

5. Spasms that limit the ability of the subjects to participate in the study training as determined by the investigator;

6. Skin conditions that limit the application of tSCS electrodes;

7. Active implanted medical devices that may be affected by tSCS;

8. Pregnant, planning to become pregnant or breastfeeding;

9. Concurrent participation in another drug or device trial that may interfere with this study;

10. Participated in wearable exoskeleton training within the last 3 months prior to enrolment.

11. Peripheral nerve injury or significant Lumbar Radiculopathy

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alexandra Hospital

OTHER

Sponsor Role: collaborator

National University Hospital, Singapore

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gobinathan Chandran, MBBS

Role: PRINCIPAL_INVESTIGATOR

National University Hospital, Singapore

Locations

Alexandra Hospital

Singapore, , Singapore

Countries

Singapore

Central Contacts

Gobinathan Chandran, MBBS

Role: CONTACT

Gobinathan_CHANDRAN@nuhs.edu.sg

(65) 94575924

Ning Tang, PhD

Role: CONTACT

ning_tang@nuhs.edu.sg

Facility Contacts

Gobinathan Chandran

Role: primary

Gobinathan_CHANDRAN@nuhs.edu.sg

94575924

Other Identifiers

2023/00350

Identifier Type: -

Identifier Source: org_study_id