Activity-Dependent Transspinal Stimulation in SCI

Summary

Robotic gait training is often used with the aim to improve walking ability in individuals with Spinal Cord Injury. However, robotic gait training alone may not be sufficient. This study will compare the effects of robotic gait training alone to robotic gait training combined with either low-frequency or high-frequency non-invasive transspinal electrical stimulation. In people with motor-incomplete SCI, a series of clinical and electrical tests of nerve function will be performed before and after 20 sessions of gait training with or without stimulation.

Conditions

• Spinal Cord Injuries
• Paraplegia, Spinal
• Tetraplegia/Tetraparesis
• Paraplegia, Spastic

Interventions

OTHER

Robotic gait training

Fifteen people with spinal cord injury will receive 20 daily sessions of robotic gait training. During assisted stepping, they will receive also non-invasive transspinal stimulation as a pulse train at 30 Hz during the stance phase of gait. Before and after training standardized clinical and neurophysiological tests will be used to assess recovery of sensorimotor function.

DEVICE

Robotic gait training and low-frequency transspinal stimulation

Fifteen people with spinal cord injury will receive 20 daily sessions of robotic gait training. During assisted stepping, they will receive also non-invasive transspinal stimulation as a single pulse at 0.3 Hz during the stance phase of gait. Before and after training standardized clinical and neurophysiological tests will be used to assess recovery of sensorimotor function.

DEVICE

Robotic gait training and high-frequency transspinal stimulation

Fifteen people with spinal cord injury will receive 20 daily sessions of robotic gait training. During assisted stepping, they will receive also non-invasive transspinal stimulation as a pulse train at 30 Hz during the stance phase of gait. Before and after training standardized clinical and neurophysiological tests will be used to assess recovery of sensorimotor function.

Sponsors & Collaborators

• Bronx Veterans Medical Research Foundation, Inc

  collaborator OTHER

• City University of New York

  lead OTHER

Principal Investigators

• Maria Knikou, PT, PhD · Research Foundation of the City University of New York

• Noam Y Harel, MD, PhD · VA Office of Research and Development

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-08-01

Primary Completion

2021-10-01

Completion

2021-10-02

FDA Device

Yes

Countries

• United States

Study Locations