Neuromodulation and Dynamic Balance in Stroke

Medical University of South Carolina53 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Stroke

Interventions

Portable Neuromodulation StimulationDEVICE

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.

ShamDEVICE

The Sham group will not receive electrical stimulation.

Gait and balance trainingOTHER

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.

Eligibility

Sex: ALLMin age: 22 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Medical University of South Carolina

Charleston, South Carolina, United States

Outcomes

Primary Outcomes

Change in gait speed

Self-selected comfortable walking overground walking speed.

Time frame: 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.

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

Data from ClinicalTrials.gov

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