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Completed

NCT Number: NCT05135533

Neuromodulation and Dynamic Balance in Stroke

Portable Neuromodulation Stimulator (PoNS) is non-invasive stimulation device placed on the tongue to stimulate those brain regions understood to be important for maintaining balance. This research study aims to collect evidence that PoNS therapy along with balance training improves postural and walking stability post-stroke.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

22 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • At least six months since the onset of Ischemic or hemorrhagic stroke.
  • Demonstrate residual paresis in the lower extremity (Fugl-Mayer lower extremity score < 34).
  • Are able to provide informed consent demonstrated by their ability to weigh the consequences of participating versus not participating in the study.
  • Can walk at least 10 feet with and without assistive device.
  • Functional Gait Assessment score <22.

Exclusion criteria

  • Pre-existing neurological disorders.
  • Previous stroke affecting the other hemisphere .
  • Severe arthritis or orthopedic problems that limit passive range of motion.
  • Areas of recent bleeding or open wounds.
  • Lack normal sensation on the tongue.
  • Received treatment for cancer within the past year.
  • Non-removable metal orthodontic devices.
  • Oral health problems.
  • Are sensitive to nickel, gold or copper.
  • Chronic infectious diseases.
  • Are pregnant.
  • Have dementia

Treatment and study plan

Portable Neuromodulation Stimulation

Device

The PoNS group will receive electrical stimulation. Net direct current to the tongue electrode less than 1 µA (micro ampere) will be administered three times a week for four weeks in-lab setting, followed by three times a week for eight weeks at-home setting. Participants will continue to be enrolled in the study for additional 12 weeks without any intervention to evaluate long term effects.

SHAM

Device

The Sham group will not receive electrical stimulation.

Gait and balance training

Other

During each session participants will receive gait training exercises for 20 minutes, 20 minutes of balance training exercises, and 20 minutes of breathing exercise three times a week for four weeks in-lab setting. This will be followed by 20 minutes of gait training exercises, 20 minutes of balance training exercises, and 20 minutes of breathing exercise three times a week for eight weeks at-home setting. Participants will continue to be enrolled in the study for additional 12 weeks without any intervention to evaluate long term effects.

Primary outcomes

  1. Change in gait speed

    Time frame: Pre-treatment, midpoint at four weeks, and post-treatment at 12 weeks

    Self-selected comfortable walking overground walking speed.

  2. Change in balance

    Time frame: Pre-treatment, midpoint at four weeks, and post-treatment at at 12 weeks

    Functional Gait Assessment (FGA) assesses stability during walking. The score ranges between 0 and 30 with lower scores indicative of poor dynamic balance.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • Brooks Rehabilitation

Registry information

Official study title

Cranial-nerve Non-invasive Neuromodulation and Dynamic Balance in Chronic Stroke Survivors

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 26, 2021
Registry last updated
Aug 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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