tSCS + UL Robotics Training in SCI Patients

NCT07432321 | Recruiting

• 1 other identifier: 2025/0420
• 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 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.

Conditions

Spinal Cord Injuries

Keywords

spinal cord injury; transcutaneous spinal cord stimulation; upper limb robotic training (ULRT)

Outcome Measures

Primary Outcomes (16)

• GRASSP 2

  The GRASSP Version 2 is a clinical impairment measure specific to the upper limb for use after tetraplegia. The GRASSP measure sensorimotor and prehension function through three domains; important in describing arm and hand function.

  Week 0

• GRASSP 2

  The GRASSP Version 2 is a clinical impairment measure specific to the upper limb for use after tetraplegia. The GRASSP measure sensorimotor and prehension function through three domains; important in describing arm and hand function.

  Week 8

• GRASSP 2

  The GRASSP Version 2 is a clinical impairment measure specific to the upper limb for use after tetraplegia. The GRASSP measure sensorimotor and prehension function through three domains; important in describing arm and hand function.

  Week 16

• GRASSP 2

  The GRASSP Version 2 is a clinical impairment measure specific to the upper limb for use after tetraplegia. The GRASSP measure sensorimotor and prehension function through three domains; important in describing arm and hand function.

  Week 20

• 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 16

• 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 20

• 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 16

• 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 20

• Capabilities of Upper Extremity Test (CUE-T)

  It is used for assessing functional limitations, assessing upper extremity functions of the subject. A higher score suggests greater upper extremity function.

  Week 0

• Capabilities of Upper Extremity Test (CUE-T)

  It is used for assessing functional limitations, assessing upper extremity functions of the subject. A higher score suggests greater upper extremity function.

  Week 8

• Capabilities of Upper Extremity Test (CUE-T)

  It is used for assessing functional limitations, assessing upper extremity functions of the subject. A higher score suggests greater upper extremity function.

  Week 16

• Capabilities of Upper Extremity Test (CUE-T)

  It is used for assessing functional limitations, assessing upper extremity functions of the subject. A higher score suggests greater upper extremity function.

  Week 20

Secondary Outcomes (32)

• Grip, Pinch and Tripod Pinch Strength, measured using Dynamometer and Pinch Gauge

  Week 0

• Grip, Pinch and Tripod Pinch Strength, measured using Dynamometer and Pinch Gauge

  Week 8

• Grip, Pinch and Tripod Pinch Strength, measured using Dynamometer and Pinch Gauge

  Week 16

• Grip, Pinch and Tripod Pinch Strength, measured using Dynamometer and Pinch Gauge

  Weeks 20

• Modified Tardieu Scale

  Week 0

Study Arms (2)

ULRT+ conventional occupational therapy

ACTIVE COMPARATOR

16 sessions of ULRT + conventional occupational therapy in 8-10 weeks

Device: ULRT + conventional occupational therapy

ULRT + tSCS + conventional occupational therapy

EXPERIMENTAL

Phase 2: 16 sessions of ULRT training + transcutaneous electrical stimulation (tSCS) + conventional occupational therapy in 8-10 weeks

Device: ULRT + tSCS + conventional occupational therapy

Interventions

ULRT + tSCS + conventional occupational therapy DEVICE

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 T11 and L1 spinous process. Reference/Ground electrodes placed over the ASIS. It will be on biphasic mode with a stimulation delivered at 30-50 Hz with a 10-kHz carrier frequency overlay, which consisted of 10 pulses with a 10-kHz frequency and 100-µs pulse width.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 ULRT training.

ULRT + tSCS + conventional occupational therapy

ULRT + conventional occupational therapy DEVICE

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.

ULRT+ conventional occupational therapy

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

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.
• 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.

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: 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: February 19, 2026
• First Posted: February 25, 2026
• Study Start: September 18, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: February 25, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)