Spinal Cord Injuries, Spinal Cord Injury Cervical
Conditions
Keywords
stroke, cerebrovascular accident, CVA
Brief summary
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.
Detailed description
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).
Interventions
OTHERActivity-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.
Sponsors
Ontario Neurotrauma Foundation
University Health Network, Toronto
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| International Standards of Neurological Classification of SCI (ISNCSCI) | 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). |
| Graded Redefined Assessment of Strength, Sensation and Prehension (GRASSP) Version 1 | 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. |
| Spinal Cord Independence Measure (SCIM) | 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. |
| Tactile Discrimination Test (TDT) | 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. |
| TRI hand function test (TRI-HFT) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neurophysiological Assessment using surface electromyography (EMG) | 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. |
Countries
Canada
Contacts
Primary ContactUrvashy Gopaul, PhD
Backup ContactGita Gholamrezaei
Outcome results
None listed