StrokeNCT05135533
Neuromodulation and Dynamic Balance in Stroke
A study testing Portable Neuromodulation Stimulation and Gait and balance training in people with Stroke, run by Medical University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- Portable Neuromodulation Stimulation and Gait and balance training
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2023to 24 Jul 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Non-removable metal orthodontic devices.
- Oral health problems.
- Are sensitive to nickel, gold or copper.
- Chronic infectious diseases.
- Are pregnant.
- Have dementia
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Cranial-nerve Non-invasive Neuromodulation and Dynamic Balance in Chronic Stroke Survivors
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.
- Conditions
- Stroke
- Being tested
- Portable Neuromodulation Stimulation, Sham, Gait and balance training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Portable Neuromodulation Stimulator | Experimental | Not described Receives: Device: Portable Neuromodulation Stimulation; Other: Gait and balance training |
| Sham | Sham comparator | Not described Receives: Device: Sham; Other: Gait and balance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gait Speed
Self-selected comfortable walking overground walking speed in cm/s.
Measured: 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.
Measured: Pre-treatment, midpoint at four weeks, and post-treatment at at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2021
- Study start28 Aug 2023
- Primary completion24 Jul 2025
- Study completion24 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Brooks Rehabilitation
- Responsible party
- Principal investigator, Steven Kautz, Medical University of South Carolina
- Investigators
- Steven Kautz, PhD, Study chair, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05135533
- Sponsor's protocol ID
- Pro00113565
- Status last verified
- Aug 2026
- First submitted
- 15 Nov 2021
- Last updated
- 13 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All of the individual participant data that underlie the results reported in the article, after de-identification.
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cranial-nerve Non-invasive Neuromodulation and Dynamic Balance in Chronic Stroke Survivors
- ClinicalTrials.gov ID
- NCT05135533
- Acronym / sponsor ID
- Pro00113565
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- Brooks Rehabilitation
- Study start
- 28 Aug 2023 (actual)
- Primary completion
- 24 Jul 2025 (actual)
- Study completion
- 24 Jul 2025 (actual)
- First posted
- 26 Nov 2021 (actual)
- Results
- Posted 13 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Portable Neuromodulation Stimulator | Experimental | Device: Portable Neuromodulation Stimulation, Other: Gait and balance training |
| Sham | Sham comparator | Device: Sham, Other: Gait and balance training |
Who may qualify
- Ages
- 22 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Portable Neuromodulation StimulationThe 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. | Device | Portable Neuromodulation Stimulator |
| ShamThe Sham group will not receive electrical stimulation. | Device | Sham |
| Gait and balance trainingDuring 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. | Other | Portable Neuromodulation Stimulator, Sham |
Primary outcome
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 in cm/s.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. All of the individual participant data that underlie the results reported in the article, after de-identification.
Related trials for Stroke
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Kautz, PhD study chair
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Portable Neuromodulation Stimulation and Gait and balance training in people with Stroke, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Gait Speed (time frame: Pre-treatment, midpoint at four weeks, and post-treatment at 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.