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

University Health Network, Toronto

Status

Enrolling

Conditions

Spinal Cord Injuries

Spinal Cord Injury Cervical

Treatments

Other: Activity-based therapy and transcutaneous spinal cord stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT06472986

20-6276

Details and patient eligibility

About

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.

Full 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).

Enrollment

24 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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