Neuromodulation With Spinal Stimulation Methods

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.

Study Overview

• Status: Recruiting
• Conditions: Spinal Cord Injuries; Spinal Cord Injury at C5-C7 Level; Paraplegia, Spinal; Paraplegia, Incomplete
• Intervention / Treatment: Device: spinal stimulation-DCS; Other: spinal stimulation-EPS; Other: spinal stimulation-sham DCS; Other: sham spinal stimulation-EPS

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 Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Katinka Stecina, PhD; Phone Number: 204 789 3761; Email: katinka.stecina@umanitoba.ca
• Study Contact Backup: Name: Kristine Cowley, PhD; Phone Number: 2047893305; Email: kristine.cowley@umanitoba.ca

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 0J9
      • Recruiting
      • University of Manitoba
      • Contact: Katinka Stecina, Ph.D.; Phone Number: 2047893761; Email: Katinka.Stecina@umanitoba.ca
      • Contact: Kristine Cowley, Ph.D.; Phone Number: 2047893305; Email: Kristine.Cowley@umanitoba.ca
    • Winnipeg, Manitoba, Canada, R3E 0J9
      • Enrolling by invitation
      • University of Manitoba

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Spinal cord stimulation; Spinal cord stimulation will be administered to participants for 15 min.	Device: spinal stimulation-DCS; transcutaneous spinal stimulation by direct current stimulation; Other: spinal stimulation-EPS; transcutaneous spinal stimulation by electrical pulsed stimulation
Sham Comparator: Shamspinal cord stimulation; Sham spinal cord stimulation will be administered to participants for 15 min.	Other: spinal stimulation-sham DCS; sham transcutaneous spinal stimulation by direct current stimulation; Other: sham spinal stimulation-EPS; sham transcutaneous spinal stimulation by electrical pulsed stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motor response	H-reflex input output curve	Immediately after stimulation (within 1-15 min)
Motor evoked potentials	MEP input-output curve	Immediately after stimulation (within 1-15 min)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure	Perception of discomfort due to stimulation	During procedure

Collaborators and Investigators

• Sponsor: University of Manitoba

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: March 9, 2021
• First Submitted That Met QC Criteria: February 21, 2024
• First Posted (Estimated): February 22, 2024

Study Record Updates

• Last Update Posted (Estimated): February 22, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Trauma, Nervous System; Spinal Cord Diseases; Paralysis; Wounds and Injuries; Spinal Cord Injuries; Paraplegia
• Other Study ID Numbers: HS23666(B2020:015)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Upon request, we will consider making anonymized data available for analysis by other researchers
• IPD Sharing Time Frame: After study completion (May 2022) for one year.
• IPD Sharing Access Criteria: Upon request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No