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Clinical Trials/NCT06272279
NCT06272279
Recruiting
Not Applicable

Neuromodulation With Spinal Stimulation Methods

University of Manitoba1 site in 1 country24 target enrollmentMarch 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Spinal Cord Injuries
Sponsor
University of Manitoba
Enrollment
24
Locations
1
Primary Endpoint
Motor evoked potentials
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2024
End Date
February 15, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Motor evoked potentials

Time Frame: Immediately after stimulation (within 1-15 min)

MEP input-output curve

Motor response

Time Frame: Immediately after stimulation (within 1-15 min)

H-reflex input output curve

Secondary Outcomes

  • Blood pressure(During the procedure/stimulation and up to 15 min after stimulation.)
  • Perception of discomfort due to stimulation(During and after procedure/stimulation and up to 15 min after stimulation.)

Study Sites (1)

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