Neuromodulation and Dynamic Balance in Stroke

NCT05135533 | Completed FDA Device

• 1 other identifier: Pro00113565
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Portable Neuromodulation Stimulator

EXPERIMENTAL

Device: Portable Neuromodulation Stimulation; Other: Gait and balance training

Sham

SHAM COMPARATOR

Device: Sham; Other: Gait and balance training

Interventions

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.

Portable Neuromodulation Stimulator

Sham DEVICE

The Sham group will not receive electrical stimulation.

Sham

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.

Portable Neuromodulation Stimulator; Sham

Eligibility Criteria

• Age: 22 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead
• Brooks Rehabilitation: collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Stroke

Interventions

Gait

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Walking; Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Steven Kautz, PhD

  Medical University of South Carolina

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Depertment Chair

Study Record Dates

• First Submitted: November 15, 2021
• First Posted: November 26, 2021
• Study Start: August 28, 2023
• Primary Completion: July 24, 2025
• Study Completion: July 24, 2025
• Last Updated: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Immediately following publication no end date
• Access Criteria: anyone who wishes to access the data

Locations

US (1)