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NCT06272279 Clinical Trial

Neuromodulation With Spinal Stimulation Methods

Spinal Cord Injuries Clinical Trial

Official title:
Neuromodulation With Spinal Stimulation Methods

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06272279
Other study ID # HS23666(B2020:015)
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 1, 2024
Est. completion date February 1, 2025

Study information
Verified date February 2024
Source University of Manitoba
Contact Katinka Stecina, PhD
Phone 204 789 3761
Email katinka.stecina@umanitoba.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 24
Est. completion date February 1, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• spinal stimulation-DCS
transcutaneous spinal stimulation by direct current stimulation
Other:
• spinal stimulation-sham DCS
sham transcutaneous spinal stimulation by direct current stimulation
• spinal stimulation-EPS
transcutaneous spinal stimulation by electrical pulsed stimulation
• sham spinal stimulation-EPS
sham transcutaneous spinal stimulation by electrical pulsed stimulation

Locations
Country Name City State
Canada University of Manitoba Winnipeg Manitoba
Canada University of Manitoba Winnipeg Manitoba

Sponsors (1)
Lead Sponsor Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Motor response H-reflex input output curve Immediately after stimulation (within 1-15 min)
Primary Motor evoked potentials MEP input-output curve Immediately after stimulation (within 1-15 min)
Secondary Blood pressure Perception of discomfort due to stimulation During procedure
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