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

NCT06472986 | Recruiting

• 1 other identifier: 20-6276
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries; Spinal Cord Injury Cervical

Keywords

stroke; cerebrovascular accident; CVA

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Neurophysiological Assessment using surface electromyography (EMG)

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

Study Arms (1)

ABT-TCSCS

EXPERIMENTAL

The participants will receive activity-based therapy combined with transcutaneous spinal cord stimulation.

Other: Activity-based therapy and transcutaneous spinal cord stimulation

Interventions

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.

ABT-TCSCS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Ontario Neurotrauma Foundation: collaborator

Study Sites (1)

Toronto Rehabilitation Institute

Toronto, Ontario, M4G 3V9, Canada

RECRUITING

Related Publications (6)

• 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.

  PMID: 21353822 RESULT

• 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.

  PMID: 21353821 RESULT

• 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.

  PMID: 22985372 RESULT

• 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.

  PMID: 31792501 RESULT

• 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.

  PMID: 23459270 RESULT

• Gopaul U, Bayley MT, Kalsi-Ryan S. Combined Activity-Based Therapy and Cervical Spinal Cord Stimulation: Active Ingredients, Targets and Mechanisms of Actions to Optimize Neurorestoration of Upper Limb Function After Cervical Spinal Cord Injury. Physiother Res Int. 2025 Apr;30(2):e70036. doi: 10.1002/pri.70036.

  PMID: 39927575 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries; Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Sukhvinder Kalsi-Ryan

  Toronto Rehabilitation Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Urvashy Gopaul, PhD

CONTACT

416-597-3422; urvashy.gopaul@uhn.ca

Gita Gholamrezaei

CONTACT

416-597-3422 .; gita.gholamrezaei@uhn.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lead of the KITE Rehabilitation and Innovation Clinics-Lyndhurst Site

Study Record Dates

• First Submitted: June 18, 2024
• First Posted: June 25, 2024
• Study Start: October 7, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: July 9, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)