Ignite Creation Date:
2024-07-17 @ 10:51 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06472986
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-06-18
Brief Title:
Activity-Based Therapy and Transcutaneous Spinal Cord Stimulation After Spinal Cord Injury ABT-TCSCS
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
Feasibility and Efficacy of Activity-Based Therapy and Transcutaneous Spinal Cord Stimulation for Neurorestoration of Upper Limbs After Cervical Spinal Cord Injury
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ABT-TCSCS
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 ie after 4 weeks Pre-cervical stimulation assessment and then after receiving 28 sessions of combined ABT and neuromodulation ie after 7 weeks Post-intervention assessment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None