Neuromodulation + Balance Training for Stroke

Overseen By Shraddha Srivastava, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical University of South Carolina

Disqualifiers: Neurological disorders, Cancer, Dementia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial explores a new device called the Portable Neuromodulation Stimulator (PoNS), which is placed on the tongue. The goal is to determine if this device, combined with balance training, can improve balance and walking in stroke survivors. Participants may receive either the actual device or a sham (inactive device for comparison). This trial suits individuals who had a stroke at least six months ago and continue to experience difficulties with leg movement and walking. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research that could enhance rehabilitation options for stroke survivors.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Portable Neuromodulation Stimulator is safe for improving balance post-stroke?

Research has shown that the Portable Neuromodulation Stimulator (PoNS) is generally safe and well-tolerated. Studies have confirmed its safety, although testing continues for stroke rehabilitation. While not yet approved in the United States specifically for stroke, it has a strong safety record in other applications. No reports have linked PoNS to serious side effects. However, as studies continue, researchers are collecting more data to confirm its safety for stroke recovery. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the Portable Neuromodulation Stimulator because it offers a novel approach to stroke recovery by combining electrical stimulation with balance training. Unlike standard treatments, which often rely on physical therapy alone, this device targets the nervous system directly to potentially enhance neuroplasticity, the brain's ability to reorganize and form new connections. This dual-action approach not only aims to improve balance and motor function more effectively but also could accelerate recovery times compared to traditional methods. By offering a portable solution, it provides a more accessible option for patients, enabling consistent use outside clinical settings.

What evidence suggests that the Portable Neuromodulation Stimulator is effective for improving balance post-stroke?

Research has shown that the Portable Neuromodulation Stimulator (PoNS), which participants in this trial may receive, can improve balance and walking in people who have had a stroke. In earlier studies, participants experienced noticeable improvements in balance and gait, suggesting that this device might aid recovery. The PoNS device sends signals to the brain through the tongue, potentially enhancing movement and stability. Other studies have also reported positive results for balance and movement, supporting the idea that PoNS therapy could benefit stroke recovery. Although this treatment is still under investigation, early results are promising. ^{1 2 6 7 8}

Who Is on the Research Team?

Steven Kautz, PhD

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

This trial is for individuals who had a stroke at least six months ago, have some weakness in their legs, can walk 10 feet with or without help, and score below certain levels on balance and walking tests. They must be able to understand the study's risks and benefits. People with other neurological issues, recent strokes in the opposite brain hemisphere, severe joint problems, tongue sensation loss, metal dental work they can't remove, or those pregnant cannot join.

Inclusion Criteria

I have weakness in my leg(s) as measured by a specific test.

It has been over 6 months since I had a stroke.

I understand the risks and benefits of joining the study.

Exclusion Criteria

I have a long-term infectious disease.

I have severe arthritis or orthopedic issues limiting my movement.

I have a neurological disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive PoNS therapy along with balance training to improve postural and walking stability

12 weeks

Regular visits for therapy sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Gait and balance training
• Portable Neuromodulation Stimulation

Trial Overview The study is testing if a device called Portable Neuromodulation Stimulator (PoNS), which stimulates the brain through the tongue to improve balance when used alongside gait and balance training exercises. Some participants will receive PoNS while others get a sham device as part of the research.

How Is the Trial Designed?

Group I: Portable Neuromodulation Stimulator Experimental Treatment 2 Interventions

Group II: Sham Placebo Group 2 Interventions

Portable Neuromodulation Stimulation is already approved in Canada, United States for the following indications:

Approved in Canada as PoNS for:

• Gait deficit due to mild and moderate symptoms from stroke
• Chronic balance deficit due to mild-to-moderate traumatic brain injury
• Gait deficit due to mild and moderate symptoms from Multiple Sclerosis

Approved in United States as PoNS for:

• Gait deficit due to mild-to-moderate symptoms from Multiple Sclerosis

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

Brooks Rehabilitation

Collaborator

Trials

16

Recruited

1,900+

Published Research Related to This Trial

Vestibular rehabilitation may improve gait performance in post-stroke patients, as indicated by two out of three studies reviewed, which assessed outcomes using tests like the 10-Meter Walking Test and Timed Up and Go Test.

However, the overall evidence is considered very low quality due to issues like small sample sizes and lack of blinding, suggesting that more rigorous and larger studies are necessary to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Vestibular Rehabilitation on Gait Performance in Patients with Stroke: A Systematic Review of Randomized Controlled Trials. Mitsutake, T., Imura, T., Tanaka, R.[2020]

In a study of 49 stroke patients, balance training combined with electromyogram-triggered functional electrical stimulation (EMG-triggered FES) significantly improved both static and dynamic balance compared to conventional training alone.

The experimental group also showed notable enhancements in ankle muscle activation on the affected side, indicating that EMG-triggered FES is an effective intervention for improving balance and muscle function in stroke rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Balance Training with Electromyogram-Triggered Functional Electrical Stimulation in the Rehabilitation of Stroke Patients. Lee, K.[2020]

A local vibration stimulus training program significantly improved postural sway and gait in 31 chronic stroke patients compared to a sham group, with notable enhancements in both standing balance and walking metrics after six weeks of training.

The training group showed greater improvements in postural sway distance and velocity, as well as gait speed, cadence, step length, and single limb support time, indicating that this intervention can effectively aid rehabilitation in stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a local vibration stimulus training programme on postural sway and gait in chronic stroke patients: a randomized controlled trial. Lee, SW., Cho, KH., Lee, WH.[2016]

A novel high-definition transcranial burst electrostimulation device was developed and tested for safety, showing compliance with all safety requirements and accurate output parameters for clinical use.

In a pilot study with six chronic stroke patients, those receiving active stimulation combined with occupational therapy showed significant improvements in upper extremity motor function and coordination compared to the sham group, with no severe adverse events reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Designing and pilot testing a novel high-definition transcranial burst electrostimulation device for neurorehabilitation. Wang, SS., Huang, YJ., Chen, JJ., et al.[2022]

Visual and haptic vertical stimulation significantly improved balance in 25 post-stroke patients, as measured by various center of pressure (COP) parameters, compared to no stimulation.

Visual stimulation was found to be more effective than haptic stimulation in enhancing balance, indicating that visual cues may play a crucial role in rehabilitation for post-stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of visual and haptic vertical stimulation on standing balance in stroke patients. Hong, SH., Im, S., Park, GY.[2021]

A 3-week balance training program using the Nintendo Wii Fit significantly improved corticomotor excitability in the tibialis anterior muscle of chronic stroke survivors, indicating potential benefits for neural recovery.

Participants also experienced enhanced reaction times and better performance in balance-related tasks, suggesting that this gaming system can be an effective tool for rehabilitation in stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Wii-based balance training on corticomotor excitability post stroke. Omiyale, O., Crowell, CR., Madhavan, S.[2022]

The use of the PoNS™ device in conjunction with a high-intensity physiotherapy program over 2 weeks led to improvements in gait and balance for a patient with cerebellar degeneration, demonstrating its efficacy.

No adverse effects were reported during the treatment, indicating that CN-NINM is a safe intervention for rehabilitation in neurological patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The combined effect of cranial-nerve non-invasive neuromodulation with high-intensity physiotherapy on gait and balance in a patient with cerebellar degeneration: a case report. Bastani, A., Cofré Lizama, LE., Zoghi, M., et al.[2022]

Peripheral somatosensory stimulation (PSS) shows immediate benefits for postural stability after a single session in stroke rehabilitation, based on a systematic review of 20 studies.

Long-term improvements in postural recovery were observed when PSS was used as an additional therapy alongside exercises, although the specific impact on the paretic leg's contribution to posture remains uncertain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peripheral somatosensory stimulation and postural recovery after stroke - a systematic review. Schröder, J., Truijen, S., Van Criekinge, T., et al.[2018]

Vagus nerve stimulation (VNS) combined with rehabilitation was found to be safe and feasible for improving arm function in stroke patients, with all participants completing the therapy despite some serious adverse events related to surgery.

At 90 days post-therapy, patients receiving active VNS showed a significant improvement in upper limb function compared to the control group, with an 88% clinically meaningful response rate, suggesting that VNS may enhance rehabilitation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vagus Nerve Stimulation Paired With Upper Limb Rehabilitation After Chronic Stroke. Kimberley, TJ., Pierce, D., Prudente, CN., et al.[2019]

In a randomized controlled study of 30 stroke patients, local vibration applied to the plantar region significantly improved postural stability and reduced fall risk within just 5 minutes of treatment.

The vibration group showed notable enhancements in balance, as measured by the Biodex Balance System, while the control group, which received no actual vibration, did not experience any significant changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immediate Effects of Plantar Vibration on Fall Risk and Postural Stability in Stroke Patients: A Randomized Controlled Trial. Önal, B., Karaca, G., Sertel, M.[2020]

The study found that neuromodulation through motor imagery and action observation did not enhance the rate of motor adaptation in a complex balance task, and actually resulted in longer adaptation times compared to the control group.

However, the results suggest that individuals with lower proprioceptive participation in balance may benefit from this type of visual neuromodulation, indicating potential for tailored interventions based on balance profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Visually-Induced Motor Imagery Effects on Motor Adaptation to Reverse Steering Cycling. A Randomized Controlled Trial. Muñoz-García, D., Serrano, JI., Ferrer-Peña, R., et al.[2023]

Citations

1. ir.heliusmedical.com ir.heliusmedical.com/news-releases/news-release-details/helius-announces-positive-outcome-portable-neuromodulation

Release Details A total of 159 patients were enrolled across the three studies, with 130 patients completing both the 12-week study treatment phase and the 12- ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06470009

Study Details | NCT06470009 | Portable Neuromodulation ... Portable Neuromodulation Stimulator (PoNS®) Therapy for Gait and Balance Deficits in Chronic Stroke Survivors: A Randomized Controlled Trial. · Study Overview.

3. researchgate.net researchgate.net/publication/321174000_The_Portable_Neuromodulation_Stimulator_PoNS_for_Neurorehabilitation

(PDF) The Portable Neuromodulation Stimulator (PoNS) for ... This form of stimulation is being investigated as a possible aid to rehabilitation of motor, cognitive, and emotional symptoms resulting from a ...

4. ponstherapy.com ponstherapy.com/news/helius-medical-technologies-inc-announces-first-clinical-evidence-of-positive-long-term-therapeutic-effects-of-pons-therapy-on-gait-deficit-improvement-in-multiple-sclerosis-from-the-pons/

Helius Medical Technologies, Inc. Announces First Clinical ... “The results from this study validate existing evidence of the efficacy of PoNS across clinical data and real-world utilization of the therapy ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8367107/

Cranial Nerve Noninvasive Neuromodulation in Adults With ... For example, significant improvements in chronic balance deficits, reducing falls, and improving gait have been reported in individuals living with moderate TBI ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38666601/

ALSUntangled #75: Portable neuromodulation stimulator ... Although reasonably safe, high costs and prescription requirements will limit PoNS accessibility. At this time, due to the lack of ALS-relevant ...

7. withpower.com withpower.com/trial/phase-3-stroke-5-2024-36176

PoNS Therapy for Stroke Survivors · Info for Participants The provided research does not directly address the safety data for PoNS Therapy or Portable Neuromodulation Stimulator specifically. However, it discusses ...

8. ir.heliusmedical.com ir.heliusmedical.com/news-releases/news-release-details/helius-announces-fda-510k-submission-ponsr-device-label

Helius Announces FDA 510(k) Submission for PoNS® ... Consistent with the existing body of clinical evidence, PoNS also confirms to be a safe and well tolerated therapy.” PoNS efficacy and safety ...