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ACTIVE NOT RECRUITING
NCT04105114
EARLY_PHASE1

Transformation of Paralysis to Stepping

Sponsor: University of Louisville

View on ClinicalTrials.gov

Summary

The main goal of the project is to develop multiple noninvasive neuromodulatory strategies to facilitate full weight bearing stepping overground in people with paralysis. We will determine the effectiveness of combining noninvasive spinal cord stimulation and the administration of buspirone (a monoaminergic agonist) in facilitating locomotor activity in a gravity-neutral apparatus, during body weight supported stepping on a treadmill, when stepping overground, or during full weight bearing stepping overground in a rolling walker. Our objective is to identify the experimental variables that define the efficacy of these novel neuromodulatory techniques over a 5 year period in 15 participants with severe spinal cord injury who are at least one year post-injury.

Official title: Transformation of Paraplegic Paralysis to Overground Stepping in Humans

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

15

Start Date

2019-09-30

Completion Date

2027-12-31

Last Updated

2026-03-13

Healthy Volunteers

No

Interventions

DRUG

Buspirone

Oral Buspirone 7.5mg - 10mg daily during the treatment phase.

DEVICE

Non-invasive Spinal Cord Stimulation

A non-invasive transcutaneous electrical spinal cord stimulator, which can be used a multiple spinal locations.

DEVICE

Overground stepping

This intervention is designed to assist people with neurological injuries for balance, standing, and stepping overground.

DEVICE

Gravity Neutral Device

This device is used to train and assess non-weight bearing stepping movements. When using the device, participants will be lying on their side with their legs suspended off the end of a table supported by small slings that are anchored securely to the apparatus.

DEVICE

Body Weight Supported Treadmill Training

Participants will be supported by a special harness while they are stepping on a treadmill. Trained technicians or therapists will be assist the trunk and legs during stepping as needed.

DEVICE

Rolling Walker

A standard rolling walker will be used for balance support and stability during stepping overground.

Locations (1)

Frazier Rehabilitation and Neuroscience Institute

Louisville, Kentucky, United States