Recruiting

Spinal Stimulation

Sponsor:

University of Manitoba

Code:

NCT06272279

Conditions

Spinal Cord Injuries

Spinal Cord Injury at C5-C7 Level

Paraplegia, Spinal

Paraplegia, Incomplete

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

spinal stimulation-DCS

spinal stimulation-sham DCS

spinal stimulation-EPS

sham spinal stimulation-EPS

Study Details

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.

Conditions

Spinal Cord Injuries

Spinal Cord Injury at C5-C7 Level

Paraplegia, Spinal

Paraplegia, Incomplete

Study ID

NCT06272279

Start date

Mar 1, 2024

Status verified date

Feb, 2025

Completion date

Feb 15, 2026

Anticipated

Primary completion date

Jan 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Spinal cord stimulation

Spinal cord stimulation will be administered to participants for 15 min.

sham comparator: Shamspinal cord stimulation

Sham spinal cord stimulation will be administered to participants for 15 min.

Interventions

spinal stimulation-DCS

transcutaneous spinal stimulation by direct current stimulation

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

Primary outcome measure

  • Motor response [ Time Frame: Immediately after stimulation (within 1-15 min) ]
  • Motor evoked potentials [ Time Frame: Immediately after stimulation (within 1-15 min) ]

Central Contacts and Locations

Central contacts

Katinka Stecina, PhD

204 789 3761katinka.stecina@umanitoba.ca

Kristine Cowley, PhD

2047893305kristine.cowley@umanitoba.ca

Locations

University of Manitoba

Recruiting

Winnipeg, Manitoba, Canada, R3E 0J9

Contacts

Katinka Stecina, Ph.D.

2047893761Katinka.Stecina@umanitoba.ca

Kristine Cowley, Ph.D.

2047893305Kristine.Cowley@umanitoba.ca

More Information

Sponsor

University of Manitoba

Last update posted

Feb 10, 2025

Last verified

Feb, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Manitoba on 2025-02-10.