An interventional study of Portable Neuromodulation Stimulation and Sham in Stroke, sponsored by Medical University of South Carolina. Completed at 1 site in United States. Open to participants aged 22 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-08-13.
Sponsored by Medical University of South Carolina · Not applicable, Interventional, and Treatment
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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 53 is close to the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →Medical University of South Carolina is the lead sponsor of 852 studies on the registry; 165 are open to participants now.
Of its 128 completed or terminated interventional studies of FDA-regulated products, 101 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: Portable Neuromodulation Stimulation · Other: Gait and balance training
Device: Sham · Other: Gait and balance training
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.
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.
Change in Gait Speed
Self-selected comfortable walking overground walking speed in cm/s.
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
| Milestone | Portable Neuromodulation Stimulator | Sham |
|---|---|---|
| Started | 25 | 21 |
| Completed | 19 | 15 |
| Not completed | 6 | 6 |
Self-selected comfortable walking overground walking speed in cm/s.
| cm/s | Portable Neuromodulation Stimulator | Sham |
|---|---|---|
| Visit 1 (Baseline) | 66.68 ± 27.06 | 64.71 ± 37.28 |
| Visit 2 (Week 4) | 69.58 ± 27.75 | 69.33 ± 37.07 |
| Visit 3 (Week 12 - Post) | 62.96 ± 30.03 | 68.69 ± 41.01 |
Functional Gait Assessment (FGA) assesses stability during walking. The score ranges between 0 and 30 with lower scores indicative of poor dynamic balance.
| score on scale | Portable Neuromodulation Stimulator | Sham |
|---|---|---|
| Visit 1 (Baseline) | 12.60 ± 5.35 | 12.71 ± 6.28 |
| Visit 2 (Week 4) | 15.77 ± 5.75 | 15.00 ± 6.75 |
| Visit 3 (Week 12 - Post) | 16.42 ± 5.98 | 15.13 ± 7.12 |
Collected over Adverse events were collected from enrollment until their final follow up assessment visit (Visit 18), up to 24 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Portable Neuromodulation Stimulator | 0/25 (0%) | 0/25 (0%) | 2/25 (8%) |
| Sham | 0/21 (0%) | 0/21 (0%) | 0/21 (0%) |
| Event | Portable Neuromodulation Stimulator | Sham |
|---|---|---|
| Wound on footMusculoskeletal and connective tissue disorders | 2/25 | 0/21 |
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 reported below.
| Age, Continuous(years) | Portable Neuromodulation Stimulator | Sham | Total |
|---|---|---|---|
| Mean | 62.76 ± 9.31 | 56.67 ± 8.2 | 59.98 ± 9.24 |
| Sex: Female, Male(Participants) | Portable Neuromodulation Stimulator | Sham | Total |
|---|---|---|---|
| Female | 12 | 7 | 19 |
| Male | 13 | 14 | 27 |
| Ethnicity (NIH/OMB)(Participants) | Portable Neuromodulation Stimulator | Sham | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 1 | 1 |
| Not Hispanic or Latino | 23 | 19 | 42 |
| Unknown or Not Reported | 2 | 1 | 3 |
| Gait Speed(cm/s) | Portable Neuromodulation Stimulator | Sham | Total |
|---|---|---|---|
| Mean | 66.68 ± 27.06 | 64.71 ± 37.28 | 65.78 ± 31.76 |
| Functional Gait Assessment(score on scale) | Portable Neuromodulation Stimulator | Sham | Total |
|---|---|---|---|
| Mean | 12.60 ± 5.35 | 12.71 ± 6.28 | 12.65 ± 5.72 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — All of the individual participant data that underlie the results reported in the article, after de-identification.
Supporting information: Csr
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Medical University of South Carolina