Transspinal Stimulation Plus Locomotor Training for SCI

Summary

Locomotor training is often used with the aim to improve corticospinal function and walking ability in individuals with Spinal Cord Injury. Excitingly, the benefits of locomotor training may be augmented by noninvasive electrical stimulation of the spinal cord and enhance motor recovery at SCI. This study will compare the effects of priming locomotor training with high-frequency noninvasive thoracolumbar spinal stimulation. In people with motor-incomplete SCI, a series of clinical and electrical tests of brain and spinal cord function will be performed before and after 40 sessions of locomotor training where spinal stimulation is delivered immediately before either lying down or during standing.

Conditions

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

Interventions

COMBINATION_PRODUCT

Standing transspinal stimulation followed by robotic gait training

Fifteen people with spinal cord injury will receive 40 daily sessions of 30 minutes of non-invasive high frequency (e.g. 30 Hz) transcutaneous transspinal stimulation during standing followed by 30 minutes of assisted stepping robotic gait training. Before and after training standardized clinical and neurophysiological tests will be used to assess recovery of sensorimotor function.

COMBINATION_PRODUCT

Lying transspinal stimulation followed by robotic gait training

Fifteen people with spinal cord injury will receive 40 daily sessions of 30 minutes of non-invasive high frequency (e.g. 30 Hz) transcutaneous transspinal stimulation while lying supine on a therapy table followed by 30 minutes of assisted stepping robotic gait training. Before and after training standardized clinical and neurophysiological tests will be used to assess recovery of sensorimotor function.

OTHER

Standing sham transspinal stimulation followed by robotic gait training

Fifteen people with spinal cord injury will receive 40 daily sessions of 30 minutes of sham transspinal stimulation during standing at an intensity where sensation is absent followed by 30 minutes of robotic gait training. 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

• Icahn School of Medicine at Mount Sinai

  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 · Bronx Veterans Medical Research Foundation

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-08-01

Primary Completion

2024-12-01

Completion

2024-12-31

FDA Device

Yes

Countries

• United States

Study Locations