Cranial-nerve Non-invasive Neuromodulation and Dynamic Balance in Chronic Stroke Survivors
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stroke
- Sponsor
- Medical University of South Carolina
- Enrollment
- 53
- Locations
- 1
- Primary Endpoint
- Change in gait speed
- Status
- Completed
- Last Updated
- 8 months ago
Overview
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.
Investigators
Steven Kautz
Depertment Chair
Medical University of South Carolina
Eligibility Criteria
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.
Outcomes
Primary Outcomes
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.
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.