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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Spinal Cord Injuries; Spinal Cord Injury Cervical
• Intervention / Treatment: Other: Activity-based therapy and transcutaneous spinal cord stimulation

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).

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Urvashy Gopaul, PhD; Phone Number: 7996 416-597-3422; Email: urvashy.gopaul@uhn.ca
• Study Contact Backup: Name: Gita Gholamrezaei; Phone Number: 6209 416-597-3422 .; Email: gita.gholamrezaei@uhn.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4G 3V9
      • Recruiting
      • Toronto Rehabilitation Institute
      • Contact: Gita Gholamrezaei, PhD; Phone Number: 6209 416-597-3422; Email: gita.gholamrezaei@uhn.ca
      • Sub-Investigator: Urvashy Gopaul, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: ABT-TCSCS; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	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.	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.	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.	At enrollment, 4-6 weeks after enrollment, after 4 weeks (12 sessions) of ABT, and after 7 weeks (28 sessions) of ABT-TCSCS

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	After 4 weeks (12 sessions) of ABT, and after 7 weeks (28 sessions) of ABT-TCSCS

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Collaborators: Ontario Neurotrauma Foundation
• Investigators: Principal Investigator: Sukhvinder Kalsi-Ryan, Toronto Rehabilitation Institute

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: June 18, 2024
• First Submitted That Met QC Criteria: June 18, 2024
• First Posted (Actual): June 25, 2024

Study Record Updates

• Last Update Posted (Actual): July 9, 2024
• Last Update Submitted That Met QC Criteria: July 7, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: stroke; cerebrovascular accident; CVA
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: 20-6276

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We do not plan to share the data from this study with any researchers outside this study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No