Neuromodulation With Spinal Stimulation Methods

Not Applicable

Recruiting

• Conditions: Spinal Cord Injuries; Spinal Cord Injury at C5-C7 Level; Paraplegia, Spinal; Paraplegia, Incomplete
• Interventions: Device: spinal stimulation-DCS; Other: spinal stimulation-sham DCS; Other: sham spinal stimulation-EPS; Other: spinal stimulation-EPS

• Registration Number: NCT06272279
• Lead Sponsor: University of Manitoba

Brief Summary

This is a pilot research study to test the protocols needed for transcutaneous spinal electrical stimulation in persons living with spinal cord injury (SCI). Up to 24 participants will be enrolled. A variety of stimulation parameters and outcome measures will be assessed.

Detailed Description

Purpose of this project

Spinal cord stimulation has the potential to improve motor function recovery after spinal cord injury. Commonly used approaches include low-intensity, direct current (DC) stimulation applied across multiple segments, electrical transcutaneous (ETC) stimulation, and magnetic transcutaneous stimulation (MTC).

Objective: to evaluate and compare the voluntary and reflexive motor performance in the same subjects, including people with and without spinal cord injury, after non-invasive spinal cord stimulation interventions. Comparing two different interventions applied in different experimental sessions and the respective sham stimulation is the goal of this study.

corticospinal and spinal motor pathways in paraplegics and in non-injured humans will be tested.

Study Timeline

• Study First Submitted: 2021-03-09
• Study First Submitted QC: 2024-02-21
• Study First Posted: 2024-02-22
• Study Start: 2024-03-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-05
• Last Update Posted: 2025-02-10
• Primary Completion: 2026-01-31
• Study Completion: 2026-02-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• spinal cord injury C4 to L4
• ability to understand and follow directions

Exclusion Criteria

• history of seizures, head injury, concussion, unexplained loss of consciousness or if they lived with an implanted cochlear stimulator, brain/neurostimulator, cardiac pacemaker, medication infusion device or live with metal implants in their body or if they are pregnant.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Shamspinal cord stimulation	sham spinal stimulation-EPS	Sham spinal cord stimulation will be administered to participants for 15 min.
Spinal cord stimulation	spinal stimulation-DCS	Spinal cord stimulation will be administered to participants for 15 min.
Spinal cord stimulation	spinal stimulation-EPS	Spinal cord stimulation will be administered to participants for 15 min.
Shamspinal cord stimulation	spinal stimulation-sham DCS	Sham spinal cord stimulation will be administered to participants for 15 min.

Primary Outcome Measures

Name	Time	Method
Motor evoked potentials	Immediately after stimulation (within 1-15 min)	MEP input-output curve
Motor response	Immediately after stimulation (within 1-15 min)	H-reflex input output curve

Secondary Outcome Measures

Name	Time	Method
Blood pressure	During the procedure/stimulation and up to 15 min after stimulation.	Measured (in arm) with inflatable cuff-automated, standard machine.
Perception of discomfort due to stimulation	During and after procedure/stimulation and up to 15 min after stimulation.	self-reporting on a scale ( the higher, the more discomfort)

Trial Locations

Locations (1)

University of Manitoba; 🇨🇦 Winnipeg, Manitoba, Canada