Clinical trial NCT06472986: Activity-Based Therapy and Transcutaneous Spinal Cord Stimulation After Spinal Cord Injury (ABT-TCSCS)
Official title: Feasibility and Efficacy of Activity-Based Therapy and Transcutaneous Spinal Cord Stimulation for Neurorestoration of Upper Limbs After Cervical Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries
Spinal Cord Injury Cervical
Keywords: stroke
cerebrovascular accident
CVA
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Ontario Neurotrauma Foundation
First posted: 2024-06-25
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: International Standards of Neurological Classification of SCI (ISNCSCI)
timeFrame: At enrollment, 4-6 weeks after enrollment, after 4 weeks (12 sessions) of ABT, and after 7 weeks (28 sessions) of ABT-TCSCS
measure: Graded Redefined Assessment of Strength, Sensation and Prehension (GRASSP) Version 1
timeFrame: At enrollment, 4-6 weeks after enrollment, after 4 weeks (12 sessions) of ABT, and after 7 weeks (28 sessions) of ABT-TCSCS
measure: Spinal Cord Independence Measure (SCIM)
timeFrame: At enrollment, 4-6 weeks after enrollment, after 4 weeks (12 sessions) of ABT, and after 7 weeks (28 sessions) of ABT-TCSCS
measure: TRI hand function test (TRI-HFT)
timeFrame: At enrollment, 4-6 weeks after enrollment, after 4 weeks (12 sessions) of ABT, and after 7 weeks (28 sessions) of ABT-TCSCS
measure: Tactile Discrimination Test (TDT)
timeFrame: At enrollment, 4-6 weeks after enrollment, after 4 weeks (12 sessions) of ABT, and after 7 weeks (28 sessions) of ABT-TCSCS
Secondary outcomes:
measure: Neurophysiological Assessment using surface electromyography (EMG)
timeFrame: After 4 weeks (12 sessions) of ABT, and after 7 weeks (28 sessions) of ABT-TCSCS
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Rehabilitation Institute
state: Ontario
Study officials:
affiliation: Toronto Rehabilitation Institute
name: Sukhvinder Kalsi-Ryan
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kirshblum S, Botticello A, Lammertse DP, Marino RJ, Chiodo AE, Jha A. The impact of sacral sensory sparing in motor complete spinal cord injury. Arch Phys Med Rehabil. 2011 Mar;92(3):376-83. doi: 10.1016/j.apmr.2010.07.242.
citation: Marino RJ, Burns S, Graves DE, Leiby BE, Kirshblum S, Lammertse DP. Upper- and lower-extremity motor recovery after traumatic cervical spinal cord injury: an update from the national spinal cord injury database. Arch Phys Med Rehabil. 2011 Mar;92(3):369-75. doi: 10.1016/j.apmr.2010.09.027.
citation: Kalsi-Ryan S, Curt A, Verrier MC, Fehlings MG. Development of the Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP): reviewing measurement specific to the upper limb in tetraplegia. J Neurosurg Spine. 2012 Sep;17(1 Suppl):65-76. doi: 10.3171/2012.6.AOSPINE1258.
citation: Kalsi-Ryan S, Riehm LE, Tetreault L, Martin AR, Teoderascu F, Massicotte E, Curt A, Verrier MC, Velstra IM, Fehlings MG. Characteristics of Upper Limb Impairment Related to Degenerative Cervical Myelopathy: Development of a Sensitive Hand Assessment (Graded Redefined Assessment of Strength, Sensibility, and Prehension Version Myelopathy). Neurosurgery. 2020 Mar 1;86(3):E292-E299. doi: 10.1093/neuros/nyz499.
citation: Kapadia N, Zivanovic V, Verrier M, Popovic MR. Toronto rehabilitation institute-hand function test: assessment of gross motor function in individuals with spinal cord injury. Top Spinal Cord Inj Rehabil. 2012 Spring;18(2):167-86. doi: 10.1310/sci1802-167.