A Novel Combined Neuromodulation Therapy to Enhance Balance and Neuroplasticity

Summary

Many people with partial damages in their spinal cord (iSCI) have physical impairments such as muscle paralysis in legs which make standing balance difficult. Poor balance control often leads to falls, injuries, and hospitalization. Therefore, improvement of standing balance is an important therapeutic goal for these individuals. Our team has shown that a therapy called visual feedback training (VFT) can improve standing balance by allowing individuals with iSCI to actively participate and follow visual feedback of their body sway on a screen like a computer game. We have also found that the application of low-energy electrical pulses to weak muscles called functional electrical stimulation (FES) during VFT can enhance the training effects. Recently, transcutaneous spinal cord stimulation (TSCS) has been discussed as a promising technique to further promote the rehabilitation effects after SCI by enhancing the connectivity between the brain and spinal cord and within the spinal pathways. However, to date, the potential of combining the two techniques (TSCS+FES) to improve the standing balance remains unknown. In this study, through the completion of a clinical trial, we will investigate the effects of an intervention that combines lumbar TSCS with FES of ankle muscles during VFT on the functional and neurophysiological outcomes in individuals living with iSCI. Participants will be randomly allocated to receive combined TSCS with FES or FES alone during VFT for 12 training sessions over 4 weeks. We expect that the new therapy would further improve balance and strengthen the neural connections between the brain and muscles. The expected changes in the neural connections will be measured by recording electrical signals from the lower limb muscles following stimulation of the motor region of the brain. Results of this study will be used for a larger-scale study in people with iSCI to improve balance and reduce falls during their daily life activities.

Conditions

• Spinal Cord Injuries
• Muscle Pareses
• Fall

Interventions

OTHER

Activity-based rehabilitation+electrical stimulation

Balance training will occur three times per week for four weeks, totaling 12 two-hour sessions. In both groups, you will be asked to stand on a force plate while playing visual feedback training (VFT) games as part of the standing balance training. A force plate is similar to a bathroom scale that you can stand on which measures your body sway during movement. Visual feedback training (VFT) is a type of activity that includes weight-shifting movements in the upright stance. VFT will be done in both groups. There will be different games as shown in figure 1 and the order of the games will be randomly chosen in each session. During each game, there will be targets that will be presented on the screen and you will have to navigate toward them . You will be able to rest between games as needed.

Sponsors & Collaborators

• University Health Network, Toronto

  lead OTHER

Principal Investigators

• Kei Masani, PhD · University Health Network, Toronto

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-11-05

Primary Completion

2026-01-30

Completion

2026-01-30

Countries

• Canada

Study Locations