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NCT Number: NCT06472986

Activity-Based Therapy and Transcutaneous Spinal Cord Stimulation After Spinal Cord Injury (ABT-TCSCS)

The ABT-TCSCS study investigates how feasible and beneficial are activity-based therapy and transcutaneous spinal cord stimulation on improving of arm and hand recovery after cervical spinal cord injury.

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Key information

Conditions

Spinal Cord Injuries Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Spinal Cord Diseases Spinal Cord Injury Cervical Stroke Trauma, Nervous System Vascular Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Toronto Rehabilitation Institute

Toronto, Ontario, M4G 3V9, Canada

Location status: Recruiting

Location contact

Gita Gholamrezaei, PhD

CONTACT

[email protected]

416-597-3422 ext. 6209

Urvashy Gopaul, PhD

SUB_INVESTIGATOR

About this study

The ABT-TCSCS is a one-arm interventional study evaluating the feasibility and efficacy of activity-based therapy and transcutaneous spinal cord stimulation on neurorestoration of upper limbs after cervical spinal cord injury. Up to 24 individuals with SCI who suffer from tetraplegia will be treated with ABT-TCSCS. All participants will receive 12 sessions of ABT (4 weeks), followed by 28 sessions of ABT-TCSCS (7 weeks). Each session will last 1 hour and delivered 3 times per week. All study participants will be assessed at the start of the study (Baseline 1) and then re-assessed after 6 weeks (Baseline 2) to ensure that they are neurologically stable. The baseline assessment will consist of the International Standards of Neurological Classification of SCI (ISNCSCI), GRASSP Version 1, the Spinal Cord Independence Measure (SCIM) and the TRI hand function test (TRI-HFT). Participants will be re-assessed after receiving 12 sessions of ABT i.e after 4 weeks (Pre-cervical stimulation assessment) and then after receiving 28 sessions of combined ABT and neuromodulation i.e after 7 weeks (Post-intervention assessment).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Individuals with chronic traumatic and non-traumatic cervical SCI (ASIA classification A-incomplete**, B, C, D) between C1-C8
  • Adults more than 18 years old
  • At least 6 months post-spinal cord injury
  • A score of 2 - 15 on the upper extremity motor score of the ISNCSCI
  • A score between 5 - 40 on GRASSP Version 1 Strength on at least one side
  • Individuals who are medically stable

Exclusion criteria

  • Individuals with any other upper extremity deficit
  • Unable to provide informed consent
  • Unable to participate in an intensive rehabilitation outpatient program
  • Spasticity that limits the range of motion greater than 50% for the elbow or wrist

Treatment and study plan

Activity-based therapy and transcutaneous spinal cord stimulation

Other

Activity Based Therapy (ABT) is a method of neuro-rehabilitation that incorporates a high intensity, long duration and effortful engagement from the individual receiving therapy, to garner improvements in sensory and motor function. The ABT constitutes 4 types of exercises including: cardio-fitness, resistance, postural/weightbearing and functional exercises. TransCutaneous Spinal Cord Stimulation (TCSCS) stimulates spinal networks in the cervical region to neuro-modulate the descending motor commands/motor intentions from the brain, which control the muscles. In tCSCS, electrical stimulation is delivered at a frequency of 30-50Hz at 500-1000µs between C3-C7. 12 sessions of ABT (4 weeks), followed by 28 sessions of ABT-TCSCS (7 weeks). Each session will last 1 hour and delivered 3 times per week.

Primary outcomes

  1. International Standards of Neurological Classification of SCI (ISNCSCI)

    Time frame: At enrollment, 4-6 weeks after enrollment, after 4 weeks (12 sessions) of ABT, and after 7 weeks (28 sessions) of ABT-TCSCS

    The ISNCSCI will be used to establish severity of injury, classify the sample and establish inclusion for study to be administered by clinicians. The ISNCSCI evaluates both motor and sensory impairment to determine the sensory and motor levels for the right and left side, the overall neurological level of the injury and completeness of the injury i.e. whether the injury is complete or incomplete. The severity of injury is graded as ASIA A = Complete, B (Sensory Incomplete), C (Motor Incomplete), D (Motor Incomplete), E (Normal).

  2. Graded Redefined Assessment of Strength, Sensation and Prehension (GRASSP) Version 1

    Time frame: At enrollment, 4-6 weeks after enrollment, after 4 weeks (12 sessions) of ABT, and after 7 weeks (28 sessions) of ABT-TCSCS

    The GRASSP Version 1 evaluates sensorimotor and prehension function of upper extremity impairment and hand function through three domains: Strength, Sensation and Prehension. It will be administered by clinicians and takes about 30-45 minutes to complete.

  3. Spinal Cord Independence Measure (SCIM)

    Time frame: At enrollment, 4-6 weeks after enrollment, after 4 weeks (12 sessions) of ABT, and after 7 weeks (28 sessions) of ABT-TCSCS

    The SCIM is a measure of independence and defines how much gain in global function one makes.

  4. TRI hand function test (TRI-HFT)

    Time frame: At enrollment, 4-6 weeks after enrollment, after 4 weeks (12 sessions) of ABT, and after 7 weeks (28 sessions) of ABT-TCSCS

    TRI-HFT will be used as a measure of functional and performance change before and after intervention.

  5. Tactile Discrimination Test (TDT)

    Time frame: At enrollment, 4-6 weeks after enrollment, after 4 weeks (12 sessions) of ABT, and after 7 weeks (28 sessions) of ABT-TCSCS

    The TDT will be used to measure of ability to discriminate differences in finely graded texture.

Secondary outcomes

  1. Neurophysiological Assessment using surface electromyography (EMG)

    Time frame: After 4 weeks (12 sessions) of ABT, and after 7 weeks (28 sessions) of ABT-TCSCS

    Neurophysiological Assessment using surface EMG will be used to determine the responses to ABT and TCSCS in multiple upper limb muscles. sEMG responses to cervical spinal stimulation will be recorded simultaneously in multiple upper limb muscles unilaterally on the 1) deltoid anterior, 2) deltoid posterior, 3) biceps brachii, 4) triceps brachii, 5) flexor carpi radialis, 6) extensor carpi radialis, 7) abductor pollicis brevis, and 8) first dorsal interosseous muscles.

Study contacts

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

Gita Gholamrezaei

CONTACT

[email protected]

416-597-3422 . ext. 6209

Urvashy Gopaul, PhD

CONTACT

[email protected]

416-597-3422 ext. 7996

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • Ontario Neurotrauma Foundation

Registry information

Official study title

Feasibility and Efficacy of Activity-Based Therapy and Transcutaneous Spinal Cord Stimulation for Neurorestoration of Upper Limbs After Cervical Spinal Cord Injury

Acronym: ABT-TCSCS

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Jun 25, 2024
Registry last updated
Jul 9, 2024

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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