Stroke
Conditions
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.
Interventions
DEVICEPortable 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.
DEVICESham
The Sham group will not receive electrical stimulation.
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.
Sponsors
Medical University of South Carolina
Brooks Rehabilitation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Gait Speed | Pre-treatment, midpoint at four weeks, and post-treatment at 12 weeks | Self-selected comfortable walking overground walking speed in cm/s. |
| Change in Balance | 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. |
Countries
United States
Contacts
STUDY_CHAIRSteven Kautz, PhD
Medical University of South Carolina
Participant flow
Pre-assignment details
Seven participants were enrolled and assigned a study ID but were not included in the Outcome Measures analysis population. These participants did not receive study intervention (device never activated) due to screen failure or other reasons for discontinuation prior to randomization/treatment initiation. As they did not receive an allocated intervention, they are not included in the arm-level results.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 62.76 years STANDARD_DEVIATION 9.31 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 42 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Functional Gait Assessment | 12.65 score on scale STANDARD_DEVIATION 5.72 |
| Gait Speed | 65.78 cm/s STANDARD_DEVIATION 31.76 |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 21 |
| other Total, other adverse events | 2 / 25 | 0 / 21 |
| serious Total, serious adverse events | 0 / 25 | 0 / 21 |
Outcome results
None listed