Neuromodulation With Spinal Stimulation Methods

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2026-02-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Semi-blinded, randomized block entry design, crossover intervention study.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

The participant will be connected to the stimulation device(s) but will not know if it has been turned on during each trial. In addition, the person analyzing the outcome data will not be aware of the stimulation status of the participant.

Study Groups

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Spinal cord stimulation

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

Group Type EXPERIMENTAL

spinal stimulation-DCS

Intervention Type DEVICE

transcutaneous spinal stimulation by direct current stimulation

spinal stimulation-EPS

Intervention Type OTHER

transcutaneous spinal stimulation by electrical pulsed stimulation

Shamspinal cord stimulation

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

Group Type SHAM_COMPARATOR

spinal stimulation-sham DCS

Intervention Type OTHER

sham transcutaneous spinal stimulation by direct current stimulation

sham spinal stimulation-EPS

Intervention Type OTHER

sham transcutaneous spinal stimulation by electrical pulsed stimulation

Interventions

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spinal stimulation-DCS

transcutaneous spinal stimulation by direct current stimulation

Intervention Type DEVICE

spinal stimulation-sham DCS

sham transcutaneous spinal stimulation by direct current stimulation

Intervention Type OTHER

spinal stimulation-EPS

transcutaneous spinal stimulation by electrical pulsed stimulation

Intervention Type OTHER

sham spinal stimulation-EPS

sham transcutaneous spinal stimulation by electrical pulsed stimulation

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes