An interventional study of Activity-based therapy and transcutaneous spinal cord stimulation in Spinal Cord Injuries and Spinal Cord Injury Cervical, sponsored by University Health Network, Toronto. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-09.
Sponsored by University Health Network, Toronto · Not applicable, Interventional, and Treatment
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.
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).
1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.
This study's planned enrollment of 24 is close to the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →University Health Network, Toronto is the lead sponsor of 1,411 studies on the registry; 292 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.
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Exclusion Criteria:
The participants will receive activity-based therapy combined with transcutaneous spinal cord stimulation.
Other: Activity-based therapy and transcutaneous spinal cord stimulation
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.
International Standards of Neurological Classification of SCI (ISNCSCI)
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).
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
Graded Redefined Assessment of Strength, Sensation and Prehension (GRASSP) Version 1
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.
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
Spinal Cord Independence Measure (SCIM)
The SCIM is a measure of independence and defines how much gain in global function one makes.
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 hand function test (TRI-HFT)
TRI-HFT will be used as a measure of functional and performance change before and after intervention.
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
Tactile Discrimination Test (TDT)
The TDT will be used to measure of ability to discriminate differences in finely graded texture.
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
Neurophysiological Assessment using surface electromyography (EMG)
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.
Time frame: After 4 weeks (12 sessions) of ABT, and after 7 weeks (28 sessions) of ABT-TCSCS
Plan to share: No — We do not plan to share the data from this study with any researchers outside this study.
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University Health Network, Toronto