Transformation of Paralysis to Stepping

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.

Conditions

• Spinal Cord Injuries

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.

Sponsors & Collaborators

• National Institutes of Health (NIH)

  collaborator NIH

• National Institute of Neurological Disorders and Stroke (NINDS)

  collaborator NIH

• University of Louisville

  lead OTHER

Principal Investigators

• Alexander V Ovechkin, PhD · University of Louisville

Study Design

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-09-30

Primary Completion

2025-08-31

Completion

2027-12-31

FDA Drug

Yes

Countries

• United States

Study Locations