Enhancing Corticospinal Activation for Improved Walking Function

Summary

For many people with spinal cord injury (SCI), the goal of walking is a high priority. There are many approaches available to restore walking function after SCI; however, these approaches often involve extensive rehabilitation training and access to facilities, qualified staff, and advanced technology that make practicing walking at home difficult. For this reason, developing training approaches that could be easily performed in the home would be of great value. In addition, non-invasive brain stimulation has the potential to increase the effectiveness of communication between the brain and spinal cord. Combining motor skill training with brain stimulation may further enhance the restoration of function in persons with SCI. Based on these findings, the primary aim of this proof-of-concept study is to inform future intervention development. To meet this aim, we will determine if moderate-intensity, motor skill training can improve walking-related outcomes among persons with SCI and to determine if the addition of non-invasive brain stimulation will result in greater improvements in function compared to training alone.

Conditions

• Spinal Cord Injuries

Interventions

OTHER

Motor Skill Training

Motor skill training will consist of activities that will be performed while standing to promote upright control (the toe-tapping activity will be performed while seated). Participants will perform each of the 6 different activities for one minute each, until 4 cycles of the circuit have been completed (approximately 25 minutes total). Motor training activities will be performed at an intensity of 40-59% of heart rate reserve (HRR). Toe tapping will provide the opportunity for scheduled rest. During MT, all participants will wear a heart rate monitor to ensure that the optimal HR range is achieved. HRR will be calculated from resting and peak heart rate measures obtained during baseline testing via administration of a graded-exercise test.

DEVICE

Transcranial direct current stimulation (tDCS)

The tDCS electrode placement is based on procedures shown to improve gait and balance in a single session when used in combination with gait training activities. tDCS electrodes can simultaneously activate the bilateral leg motor areas when placed at the midline of the scalp slightly anterior to the vertex (anode) and at the inion (cathode), with a current intensity of 2mA. The tDCS device is lightweight, and can be worn in a backpack during the MT activities. As reported previously, participants in the MT-only group will receive sham tDCS to maintain analogous study procedures.

Sponsors & Collaborators

• National Institute on Disability, Independent Living, and Rehabilitation Research

  collaborator FED

• Shepherd Center, Atlanta GA

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-03-01

Primary Completion

2020-03-01

Completion

2021-07-01

FDA Device

Yes

Countries

• United States

Study Locations