Neuromodulation With Spinal Stimulation Methods

University of Manitoba

Status: Enrolling

Conditions: Spinal Cord Injuries; Paraplegia, Incomplete; Paraplegia, Spinal; Spinal Cord Injury at C5-C7 Level

Treatments: Other: spinal stimulation-EPS; Device: spinal stimulation-DCS; Other: spinal stimulation-sham DCS; Other: sham spinal stimulation-EPS

Study type: Interventional

Funder types: Other

Identifiers

NCT06272279

HS23666(B2020:015)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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24 participants in 2 patient groups

Spinal cord stimulation

Experimental group

Description:

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

Treatment:

Device: spinal stimulation-DCS

Other: spinal stimulation-EPS

Shamspinal cord stimulation

Sham Comparator group

Description:

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

Treatment:

Other: sham spinal stimulation-EPS

Other: spinal stimulation-sham DCS