tSCS + UL Robotics Training in SCI Patients

Official title

A Pilot Study on the Cumulative Effects of Transcutaneous Spinal Cord Stimulation (tSCS) With Upper Limb Robotics Training in Upper Limb Rehabilitation in Patients With Tetraplegic Spinal Cord Injury

Overview

This study is aimed to evaluate whether transcutaneous spinal cord stimulation (tSCS) can augment upper limb robotic training (ULRT) to improve functional mobility in participants with chronic spinal cord injuries. It also evaluates the impact of the tSCS+ULRT on health-related quality of life (HRQOL), compared to ULRT alone. This is a prospective single-arm crossover study in participants with incomplete chronic traumatic spinal cord injury. 6 to 8 subjects with C2-8 level injuries will be recruited. The intervention includes Phase 1 of training which consists of 16 sessions of ULRT + conventional occupational therapy in 8-10 weeks, and Phase 2 of training which consists of 16 sessions of ULRT training + tSCS + conventional occupational therapy in 8-10 weeks. Outcome measures including mobility function assessment and neuromuscular assessment will be collected at Baseline, Post-Phase 1, Post-Phase 2, and 4 weeks Follow-up. A satisfaction survey on the intervention "ULRT training + tSCS + conventional physiotherapy" will be performed at end of the study.

Detailed description

This study is aimed to evaluate whether transcutaneous spinal cord stimulation (tSCS) can augment upper limb robotic training (ULRT) to improve functional mobility in participants with chronic paraplegia. It also evaluate the impact of the tSCS+ULRT on health-related quality of life (HRQOL), compared to ULRT alone.

This is a prospective single-arm crossover study in participants with incomplete chronic traumatic spinal cord injury. 6 subjects with C2-8 level injuries 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 upper limb robotic training (ULRT) + conventional occupational therapy in 8-10 weeks. After a 1-week washout period, subject will undergo Phase 2 of training which consists of 16 sessions of ULRT training + tSCS + conventional occupational therapy in 8-10 weeks.

This study will use the locally developed H-Man arm rehabilitation robot and Esoglove™ PRO hand rehabilitation system for ULRT. The H-Man robot, a table-top, portable, 2D planar, end-effector with virtual reality feedback is designed to deliver self-paced, repetitive reaching arm movements. The soft robotic glove EsoGlove enables patients to carry out upper-limb rehabilitation with multiple training modes, such as passive training, active-assisted range of motion training, and bilateral training. Participants could choose either H-man or Esoglove, or use both alternatively for ULRT training, according to their functional impairment. ULRT will be paired with functional training during the intervention sessions.

During tSCS, two surface electrodes will be positioned in between the vertebral processes located generally one vertebral segment rostral and one vertebral segment caudal to the site of injury. 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), Post-Phase 2 (within 1 week after Phase 2 of training), and 4 weeks Post Phase 2

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

Interventions

• Device ULRT + tSCS + conventional occupational therapy
  Subject will undergo 16 sessions of Upper limb robotics training (ULRT) + tSCS+ conventional occupational therapy, 2 sessions a week for 8-10 weeks. Participants will use either H-Man arm rehabilitation robot or Esoglove™ PRO hand rehabilitation system, or both according to their functional impairment for ULRT. Participants will undergo conventional occupational therapy as prescribed by the attending occupational therapist based on their assessment. During tSCS, cathodes will be placed on the T1
• Device ULRT + conventional occupational therapy
  Participants will undergo 16 sessions of ULRT + conventional occupational therapy in 8-10 weeks. Participants will use either H-Man arm rehabilitation robot or Esoglove™ PRO hand rehabilitation system, or both according to their functional impairment for ULRT. Participants will undergo conventional occupational therapy as prescribed by the attending occupational therapist based on their assessment.

Primary outcome measures

• GRASSP 2 [Time frame: Week 0]
• GRASSP 2 [Time frame: Week 8]
• GRASSP 2 [Time frame: Week 16]
• GRASSP 2 [Time frame: Week 20]
• International standards for Neurological Classification of SCI (ISNCSCI) [Time frame: Week 0]
• International standards for Neurological Classification of SCI (ISNCSCI) [Time frame: Week 8]
• International standards for Neurological Classification of SCI (ISNCSCI) [Time frame: Week 16]
• International standards for Neurological Classification of SCI (ISNCSCI) [Time frame: Week 20]
• Central motor conduction time (CMCT) [Time frame: Week 0]
• Central motor conduction time (CMCT) [Time frame: Week 8]

Secondary outcome measures (12)

• Grip, Pinch and Tripod Pinch Strength, measured using Dynamometer and Pinch Gauge [Time frame: Week 0]
• Grip, Pinch and Tripod Pinch Strength, measured using Dynamometer and Pinch Gauge [Time frame: Week 8]
• Grip, Pinch and Tripod Pinch Strength, measured using Dynamometer and Pinch Gauge [Time frame: Week 16]
• Grip, Pinch and Tripod Pinch Strength, measured using Dynamometer and Pinch Gauge [Time frame: Weeks 20]
• Modified Tardieu Scale [Time frame: Week 0]
• Modified Tardieu Scale [Time frame: Week 8]
• Modified Tardieu Scale [Time frame: Week 16]
• Modified Tardieu Scale [Time frame: Week 20]
• EQ5D [Time frame: Week 0]
• EQ5D [Time frame: Week 8]
• EQ5D [Time frame: Week 16]
• EQ5D [Time frame: Week 20]

Eligibility criteria

Inclusion criteria

• At least 6 months to 5 years from the diagnosis of the traumatic SCI;
• Participants between 21 and 80 years of age;
• C2-8 level injuries;
• ISNCSCI-UEMS >25,
• Pinch force > 25 N;
• Grasp force > 100 N;
• Able to perform the box and block test;
• Sitting tolerance for at least 1 hour (No known postural hypotension issues or pressure intolerance);
• Capable of providing an informed consent;
• Cleared by Neurosurgeons/Orthopaedic Surgeon for tSCS;

Exclusion criteria

• 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.
• Has an autoimmune etiology of spinal cord dysfunction/injury
• History of additional neurologic disease, such as stroke, multiple sclerosis and traumatic brain Injury.
• Pain in shoulder and/or hand which will be inhibitory towards rehabilitative therapy.
• Severe Upper limb contractures.
• Acute Medical conditions to Upper limb (ie Fractures that would limit ROM and/or weightbearing).
• Participants who are pregnant.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Open label

Primary purpose

Treatment

Study locations

Singapore · 1 center

• Alexandra Hospital — Singapore

Identifiers

NCT: NCT07432321 · 2025/0420

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗