Clinical trial NCT05921175: tSCS + EksoGT in SCI Patients
Official title: A Pilot Study on the Cumulative Effects of Transcutaneous Spinal Cord Stimulation (tSCS) With Robotic Gait Training in Trunk Muscle Activity and Walking Index in Chronic Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Spinal Cord Injury
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
Collaborators: name: Alexandra Hospital
First posted: 2023-06-27
Enrollment: 6
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a prospective single-arm crossover study in participants with incomplete chronic traumatic spinal cord paraplegia.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Spinal Cord Injury - Trunk Control Test (SCI-TCT)
timeFrame: Week 0
measure: Spinal Cord Injury - Trunk Control Test (SCI-TCT)
timeFrame: Week 8
measure: Spinal Cord Injury - Trunk Control Test (SCI-TCT)
timeFrame: Week 17
measure: Walking Index in Spinal Cord Injury-II (WISCI-II)
timeFrame: Week 0
measure: Walking Index in Spinal Cord Injury-II (WISCI-II)
timeFrame: Week 8
measure: Walking Index in Spinal Cord Injury-II (WISCI-II)
timeFrame: Week 17
measure: 10-Meter Walk Test (10MWT)
timeFrame: Week 0
measure: 10-Meter Walk Test (10MWT)
timeFrame: Week 8
measure: 10-Meter Walk Test (10MWT)
timeFrame: Week 17
measure: Central motor conduction time (CMCT)
timeFrame: Week 0
measure: Central motor conduction time (CMCT)
timeFrame: Week 8
measure: Central motor conduction time (CMCT)
timeFrame: Week 17
measure: International standards for Neurological Classification of SCI (ISNCSCI)
timeFrame: Week 0
measure: International standards for Neurological Classification of SCI (ISNCSCI)
timeFrame: Week 8
measure: International standards for Neurological Classification of SCI (ISNCSCI)
timeFrame: Week 17
Secondary outcomes:
measure: EQ5D
timeFrame: Week 0
measure: EQ5D
timeFrame: Week 8
measure: EQ5D
timeFrame: Week 17
measure: Modified Tardieu Scale
timeFrame: Week 0
measure: Modified Tardieu Scale
timeFrame: Week 8
measure: Modified Tardieu Scale
timeFrame: Week 17
measure: EMG measurement
timeFrame: Week 0
measure: EMG measurement
timeFrame: Week 8
measure: EMG measurement
timeFrame: Week 17
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Alexandra Hospital
Study officials:
affiliation: National University Hospital, Singapore
name: Gobinathan Chandran, MBBS
role: PRINCIPAL_INVESTIGATOR
References: