Neuromodulation and Dynamic Balance in Stroke

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

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Device: Sham; Device: Portable Neuromodulation Stimulation; Other: Gait and balance training

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Sham	Device: Sham; The Sham group will not receive electrical stimulation.; Other: Gait and balance training; 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.
Experimental: Portable Neuromodulation Stimulator	Device: Portable Neuromodulation Stimulation; 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.; Other: Gait and balance training; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in gait speed	Self-selected comfortable walking overground walking speed.	Pre-treatment, midpoint at four weeks, and post-treatment at 12 weeks
Change in balance	Functional Gait Assessment (FGA) assesses stability during walking. The score ranges between 0 and 30 with lower scores indicative of poor dynamic balance.	Pre-treatment, midpoint at four weeks, and post-treatment at at 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Postural balance	Sensory organization test (SOT) score that is the gold standard for quantifying postural balance and fall risk. The score ranges between 0 and 100 with lower scores indicative of poor balance.	Pre-treatment and post-treatment following four weeks of intervention

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: Brooks Rehabilitation
• Investigators: Study Chair: Steven Kautz, PhD, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2023
• Primary Completion (Actual): July 24, 2025
• Study Completion (Actual): July 24, 2025

Study Registration Dates

• First Submitted: November 15, 2021
• First Submitted That Met QC Criteria: November 15, 2021
• First Posted (Actual): November 26, 2021

Study Record Updates

• Last Update Posted (Estimated): August 15, 2025
• Last Update Submitted That Met QC Criteria: August 12, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: Pro00113565

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All of the individual participant data that underlie the results reported in the article, after de-identification.
• IPD Sharing Time Frame: Immediately following publication no end date
• IPD Sharing Access Criteria: anyone who wishes to access the data
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No