Recruiting

ABT & TCSCS

Sponsor:

University Health Network, Toronto

Code:

NCT06472986

Conditions

Spinal Cord Injuries

Spinal Cord Injury Cervical

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Activity-based therapy and transcutaneous spinal cord stimulation

Study Details

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

Study ID

NCT06472986

Start date

Oct 7, 2022

Status verified date

Jul, 2024

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

24 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ABT-TCSCS

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

Interventions

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.

Primary outcome measure

  • International Standards of Neurological Classification of SCI (ISNCSCI) [ 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 [ 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) [ 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) [ 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) [ 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 ]

Central Contacts and Locations

Central contacts

Urvashy Gopaul, PhD

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

Gita Gholamrezaei

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

Locations

Toronto Rehabilitation Institute

Recruiting

Toronto, Ontario, Canada, M4G 3V9

Contacts

Gita Gholamrezaei, PhD

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

More Information

Sponsor

University Health Network, Toronto

Last update posted

Jul 9, 2024

Last verified

Jul, 2024

Keywords

  • stroke
  • cerebrovascular accident
  • CVA

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2024-07-09.