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NCT Number: NCT07432321

tSCS + UL Robotics Training in SCI Patients

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.

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Key information

Conditions

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

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 + 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.

Primary outcomes

  1. GRASSP 2

    Time frame: Week 0

    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.

  2. GRASSP 2

    Time frame: Week 8

    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.

  3. GRASSP 2

    Time frame: Week 16

    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.

  4. GRASSP 2

    Time frame: Week 20

    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.

  5. International standards for Neurological Classification of SCI (ISNCSCI)

    Time frame: Week 0

    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)

  6. International standards for Neurological Classification of SCI (ISNCSCI)

    Time frame: Week 8

    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)

  7. International standards for Neurological Classification of SCI (ISNCSCI)

    Time frame: Week 16

    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)

  8. International standards for Neurological Classification of SCI (ISNCSCI)

    Time frame: Week 20

    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)

  9. Central motor conduction time (CMCT)

    Time frame: Week 0

    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.

  10. Central motor conduction time (CMCT)

    Time frame: Week 8

    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.

  11. Central motor conduction time (CMCT)

    Time frame: Week 16

    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.

  12. Central motor conduction time (CMCT)

    Time frame: Week 20

    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.

  13. Capabilities of Upper Extremity Test (CUE-T)

    Time frame: Week 0

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

  14. Capabilities of Upper Extremity Test (CUE-T)

    Time frame: Week 8

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

  15. Capabilities of Upper Extremity Test (CUE-T)

    Time frame: Week 16

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

  16. Capabilities of Upper Extremity Test (CUE-T)

    Time frame: Week 20

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

Secondary outcomes

  1. Grip, Pinch and Tripod Pinch Strength, measured using Dynamometer and Pinch Gauge

    Time frame: Week 0

    To assess grip and pinch strength, a dynamometer is used for overall grip and a pinch gauge measures different pinch type. Testing involves subject sitting with arm bent at the elbow to 90 degrees and forearm in neutral position. The subject will squeeze the dynamometer and pinch the gauge as hard as possible in a smooth motion. Three trials will be performed, and the average of these recordings is recorded.

  2. Grip, Pinch and Tripod Pinch Strength, measured using Dynamometer and Pinch Gauge

    Time frame: Week 8

    To assess grip and pinch strength, a dynamometer is used for overall grip and a pinch gauge measures different pinch type. Testing involves subject sitting with arm bent at the elbow to 90 degrees and forearm in neutral position. The subject will squeeze the dynamometer and pinch the gauge as hard as possible in a smooth motion. Three trials will be performed, and the average of these recordings is recorded.

  3. Grip, Pinch and Tripod Pinch Strength, measured using Dynamometer and Pinch Gauge

    Time frame: Week 16

    To assess grip and pinch strength, a dynamometer is used for overall grip and a pinch gauge measures different pinch type. Testing involves subject sitting with arm bent at the elbow to 90 degrees and forearm in neutral position. The subject will squeeze the dynamometer and pinch the gauge as hard as possible in a smooth motion. Three trials will be performed, and the average of these recordings is recorded.

  4. Grip, Pinch and Tripod Pinch Strength, measured using Dynamometer and Pinch Gauge

    Time frame: Weeks 20

    To assess grip and pinch strength, a dynamometer is used for overall grip and a pinch gauge measures different pinch type. Testing involves subject sitting with arm bent at the elbow to 90 degrees and forearm in neutral position. The subject will squeeze the dynamometer and pinch the gauge as hard as possible in a smooth motion. Three trials will be performed, and the average of these recordings is recorded.

  5. Modified Tardieu Scale

    Time frame: Week 0

    Modified Tardieu Scale is to measure if there is spasticity present in a person's muscle and its response to movement. It will be measured for Quadriceps, Hamstrings, Gastrocnemius. A large difference between R1 and R2 suggests a large dynamic component with a greater capacity for change or improvement. A small difference between R1 and R2 suggests a predominantly fixed contracture in the muscle with a poorer capacity for change.

  6. Modified Tardieu Scale

    Time frame: Week 8

    Modified Tardieu Scale is to measure if there is spasticity present in a person's muscle and its response to movement. It will be measured for Quadriceps, Hamstrings, Gastrocnemius. A large difference between R1 and R2 suggests a large dynamic component with a greater capacity for change or improvement. A small difference between R1 and R2 suggests a predominantly fixed contracture in the muscle with a poorer capacity for change.

  7. Modified Tardieu Scale

    Time frame: Week 16

    Modified Tardieu Scale is to measure if there is spasticity present in a person's muscle and its response to movement. It will be measured for Quadriceps, Hamstrings, Gastrocnemius. A large difference between R1 and R2 suggests a large dynamic component with a greater capacity for change or improvement. A small difference between R1 and R2 suggests a predominantly fixed contracture in the muscle with a poorer capacity for change.

  8. Modified Tardieu Scale

    Time frame: Week 20

    Modified Tardieu Scale is to measure if there is spasticity present in a person's muscle and its response to movement. It will be measured for Quadriceps, Hamstrings, Gastrocnemius. A large difference between R1 and R2 suggests a large dynamic component with a greater capacity for change or improvement. A small difference between R1 and R2 suggests a predominantly fixed contracture in the muscle with a poorer capacity for change.

  9. EQ5D

    Time frame: Week 0

    EQ5D is an instrument which evaluates the generic quality of life developed in Europe and widely used. It has one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each dimension scored from 1 to 5, the higher score indicates worse performance.

  10. EQ5D

    Time frame: Week 8

    EQ5D is an instrument which evaluates the generic quality of life developed in Europe and widely used. It has one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each dimension scored from 1 to 5, the higher score indicates worse performance.

  11. EQ5D

    Time frame: Week 16

    EQ5D is an instrument which evaluates the generic quality of life developed in Europe and widely used. It has one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each dimension scored from 1 to 5, the higher score indicates worse performance.

  12. EQ5D

    Time frame: Week 20

    EQ5D is an instrument which evaluates the generic quality of life developed in Europe and widely used. It has one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each dimension scored from 1 to 5, the higher score indicates worse performance.

  13. EMG measurement

    Time frame: Week 0

    EMG signals from bilateral Quadriceps, Tibialis Anterior, Gastrocnemius, Rectus Abdominis will be recorded for about 10 seconds. Root-Mean-Square (RMS) of the EMG signals will be calculated.

  14. EMG measurement

    Time frame: Week 8

    EMG signals from bilateral Biceps, Triceps, Wrist Extensors/Flexors and Finger Extensors/Flexors will be recorded for about 10 seconds. Root-Mean-Square (RMS) of the EMG signals will be calculated.

  15. EMG measurement

    Time frame: Week 16

    EMG signals from bilateral Biceps, Triceps, Wrist Extensors/Flexors and Finger Extensors/Flexors will be recorded for about 10 seconds. Root-Mean-Square (RMS) of the EMG signals will be calculated.

  16. EMG measurement

    Time frame: Week 20

    EMG signals from bilateral Biceps, Triceps, Wrist Extensors/Flexors and Finger Extensors/Flexors will be recorded for about 10 seconds. Root-Mean-Square (RMS) of the EMG signals will be calculated.

  17. Box and Block Assessment

    Time frame: Week 0

    It assesses gross motor dexterity by measuring the number of small blocks the subject can move from one compartment of a box to another within 60 seconds.

  18. Box and Block Assessment

    Time frame: Week 8

    It assesses gross motor dexterity by measuring the number of small blocks the subject can move from one compartment of a box to another within 60 seconds.

  19. Box and Block Assessment

    Time frame: Week 16

    It assesses gross motor dexterity by measuring the number of small blocks the subject can move from one compartment of a box to another within 60 seconds.

  20. Box and Block Assessment

    Time frame: Week 20

    It assesses gross motor dexterity by measuring the number of small blocks the subject can move from one compartment of a box to another within 60 seconds.

  21. Nine Hole Peg Test

    Time frame: Week 0

    It is a standardized, quantitative assessment used to measure finger dexterity. It is administered by asking the subject to take the pegs from a container, one by one, and place them into holes on the board as quickly as possible. The subject must then remove the pegs from the holes, one by one, and replace them back into the container.

  22. Nine Hole Peg Test

    Time frame: Week 8

    It is a standardized, quantitative assessment used to measure finger dexterity. It is administered by asking the subject to take the pegs from a container, one by one, and place them into holes on the board as quickly as possible. The subject must then remove the pegs from the holes, one by one, and replace them back into the container.

  23. Nine Hole Peg Test

    Time frame: Week 16

    It is a standardized, quantitative assessment used to measure finger dexterity. It is administered by asking the subject to take the pegs from a container, one by one, and place them into holes on the board as quickly as possible. The subject must then remove the pegs from the holes, one by one, and replace them back into the container.

  24. Nine Hole Peg Test

    Time frame: Week 20

    It is a standardized, quantitative assessment used to measure finger dexterity. It is administered by asking the subject to take the pegs from a container, one by one, and place them into holes on the board as quickly as possible. The subject must then remove the pegs from the holes, one by one, and replace them back into the container.

  25. Spinal Cord Injury Independence Measure (SCIIM)

    Time frame: Week 0

    It is for assessing ADL function. It looks at self-care, respiration and sphincter management, and a patient's mobility abilities. Scores range from 0 (total dependence) to 100 (complete independence).

  26. Spinal Cord Injury Independence Measure (SCIIM)

    Time frame: Week 8

    It is for assessing ADL function. It looks at self-care, respiration and sphincter management, and a patient's mobility abilities. Scores range from 0 (total dependence) to 100 (complete independence).

  27. Spinal Cord Injury Independence Measure (SCIIM)

    Time frame: Week 16

    It is for assessing ADL function. It looks at self-care, respiration and sphincter management, and a patient's mobility abilities. Scores range from 0 (total dependence) to 100 (complete independence).

  28. Spinal Cord Injury Independence Measure (SCIIM)

    Time frame: Week 20

    It is for assessing ADL function. It looks at self-care, respiration and sphincter management, and a patient's mobility abilities. Scores range from 0 (total dependence) to 100 (complete independence).

  29. Modified Goal attainment Scale (GAS)

    Time frame: Week 0

    It provides a measure of how much of patient identified goals are achieved at the time of assessment.

  30. Modified Goal attainment Scale (GAS)

    Time frame: Week 8

    It provides a measure of how much of patient identified goals are achieved at the time of assessment.

  31. Modified Goal attainment Scale (GAS)

    Time frame: Week 16

    It provides a measure of how much of patient identified goals are achieved at the time of assessment.

  32. Modified Goal attainment Scale (GAS)

    Time frame: Week 20

    It provides a measure of how much of patient identified goals are achieved at the time of assessment.

Study contacts

Contact information is provided by the study sponsor or research team.

Gobinathan Chandran, MBBS

CONTACT

[email protected]

(65) 94575924

Ning Tang, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

National University Hospital, Singapore

Other

Collaborators

  • Alexandra Hospital

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 25, 2026
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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