Neuromodulation and Dynamic Balance in Stroke

Study Overview
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Brief Summary
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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.

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

Conditions
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Stroke

Intervention / Treatment
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* Device: Portable Neuromodulation Stimulation
* Device: Sham
* Other: Gait and balance training


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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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 |