PoNS Therapy for Stroke Survivors

Not currently recruiting at 5 trial locations

Overseen By Mark Bowden

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Helius Medical Inc

Disqualifiers: Neurological disorders, Dementia, Cancer, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called PoNS Therapy (Portable Neuromodulation Stimulator) to assist people who have had a stroke. The main goal is to determine if PoNS Therapy is safe and can improve walking and balance. The trial also examines how the therapy affects quality of life and whether it reduces the risk of falling. Individuals who experienced a stroke more than six months ago and have difficulty walking might be suitable for this study. As an unphased trial, this study provides 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. However, it does exclude participants using certain stimulation devices or those who have had neurostimulation therapy recently.

What prior data suggests that PoNS therapy is safe for stroke survivors?

Research has shown that PoNS Therapy has undergone safety testing in several studies. One study included 159 stroke survivors and assessed the therapy's safety and effectiveness. Although specific safety details are not provided, multiple trials have reviewed the treatment. The PoNS device is non-invasive and stimulates nerves on the tongue to aid balance and walking. Its testing in several trials and progress toward FDA approval for other uses suggest it is generally well-tolerated. However, like any treatment, some side effects may occur. Always consult a doctor to determine if it is suitable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about PoNS Therapy for stroke survivors because it offers a unique approach compared to traditional rehabilitation methods like physical therapy and medication. Unlike these standard treatments, PoNS Therapy uses translingual neurostimulation, a novel method that involves stimulating the brain through the tongue to enhance neural recovery. This approach could potentially speed up rehabilitation and improve motor function more effectively than conventional therapies. By targeting the brain's plasticity directly, PoNS Therapy holds promise for better and faster recovery outcomes for stroke patients.

What evidence suggests that PoNS Therapy is effective for stroke survivors?

Research has shown that PoNS Therapy, studied in this trial, may help stroke survivors enhance their balance and walking. In studies with 159 participants, the treatment led to noticeable improvements in their walking and balance. PoNS Therapy uses neurostimulation, sending signals to the brain to aid physical recovery. Participants have responded well to the treatment, and plans exist to submit it to the FDA for approval based on these positive results. Overall, the therapy appears to be a promising option for aiding stroke patient recovery. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for chronic stroke survivors who are experiencing issues with walking and balance. Participants should be able to commit to the study duration and follow-up requirements. Specific eligibility details aren't provided, but typically, trials exclude individuals with conditions that could interfere with the treatment or skew results.

Inclusion Criteria

FGA score < 23 at screening

Able to understand, learn and apply instructions on how to operate the PoNS device and perform the rehabilitation exercise program

Montreal Cognitive Assessment 5-min (MoCA 5-min) ≥ 6

Exclusion Criteria

Pregnancy

I have undergone neurostimulation therapy in the last 6 months.

I have not received cancer treatment in the last year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part 1

Participants undergo DGB training in clinic supervised by the Trainer

4 weeks

Weekly visits (in-person)

Treatment Part 2

Participants continue DGB training at home, unsupervised, with weekly follow-ups

8 weeks

Weekly visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, encouraged to continue physical rehabilitation

12 weeks

Final visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• PoNS Therapy

Trial Overview The trial is testing PoNS Therapy—a device aimed at improving gait and balance in people who have had a stroke. The study will look at safety, how well it works for walking and balance, its lasting effects, fall risks, adherence to using the device, and overall quality of life.

How Is the Trial Designed?

Group I: Single Arm Experimental Treatment 1 Intervention

open label administration of translingual neurostimulation.

PoNS Therapy is already approved in Canada 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

Who Is Running the Clinical Trial?

Helius Medical Inc

Lead Sponsor

Trials

10

Recruited

370+

Antonella Favit-VanPelt

Lead Sponsor

Trials

1

Recruited

30+

Published Research Related to This Trial

Vagus nerve stimulation (VNS), both invasive and non-invasive, significantly improves motor function and reduces motor impairment in stroke patients, based on a systematic review and meta-analysis of multiple studies.

The study found no significant difference in adverse events between VNS and control groups, suggesting that VNS is a safe intervention for enhancing recovery in stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects and safety of vagus nerve stimulation on upper limb function in patients with stroke: a systematic review and meta-analysis. Abdullahi, A., Wong, TWL., Ng, SSM.[2023]

Transcutaneous electrical nerve stimulation (TENS) significantly improved activities of daily living (ADL) in stroke patients, with notable enhancements in various tasks such as feeding, walking, and dressing, compared to a placebo group.

The study involved 60 stroke patients over 40 sessions (8 weeks), and while both groups showed improvements, the active TENS group demonstrated greater overall functional gains and reduced spasticity, although initial differences in disability levels may affect the results' interpretation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of transcutaneous electrical nerve stimulation (TENS) on Barthel Activities of Daily Living (ADL) index score following stroke. Tekeoğlu, Y., Adak, B., Göksoy, T.[2022]

Recent advances in stroke recovery therapies, including activity-based therapies, brain stimulation techniques, and robotics-assisted therapies, aim to enhance neural plasticity and improve rehabilitation outcomes for stroke patients.

A multidisciplinary approach and individualized treatment plans, supported by large-scale clinical trials, are essential for maximizing recovery and addressing the diverse needs of stroke survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in Stroke Neurorehabilitation. Gunduz, ME., Bucak, B., Keser, Z.[2023]

Despite various treatments available for improving blood flow after a stroke, there is a significant need for effective rehabilitation methods to enhance neurological recovery, as most stroke survivors with motor impairments do not fully regain their previous functional abilities.

Emerging rehabilitation therapies, such as selective serotonin reuptake inhibitors, constraint-induced movement therapy, noninvasive brain stimulation, mirror therapy, and motor imagery, show promise in restoring motor function and improving the quality of life for stroke survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emerging treatments for motor rehabilitation after stroke. Claflin, ES., Krishnan, C., Khot, SP.[2022]

Vagus Nerve Stimulation (VNS) combined with physical rehabilitation significantly improves upper limb motor function in stroke patients, with an average increase of 7.06 points on the Fugl-Meyer scale compared to control interventions.

The intervention is considered safe, as no deaths or serious adverse events were reported, although some patients experienced mild side effects like dysphonia and nausea.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Vagus Nerve Stimulation on Upper Limb Motor Recovery After Stroke. A Systematic Review and Meta-Analysis. Ramos-Castaneda, JA., Barreto-Cortes, CF., Losada-Floriano, D., et al.[2022]

Neuromodulation techniques like repetitive transcranial magnetic stimulation (rTMS) and transcranial direct current stimulation (tDCS) show promise for enhancing motor recovery in stroke patients, with some studies indicating definite efficacy for low-frequency rTMS in improving hand motor recovery during the post-acute stage.

Adjunctive vagal nerve stimulation has received FDA approval for improving upper limb motor recovery in chronic ischemic stroke patients, highlighting the potential of neuromodulation as a valuable addition to standard rehabilitation therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuromodulation for Post-Stroke Motor Recovery: a Narrative Review of Invasive and Non‑Invasive Tools. Keser, Z., Ikramuddin, S., Shekhar, S., et al.[2023]

Non-invasive brain stimulation (NIBS) techniques, such as transcranial magnetic stimulation and transcranial direct current stimulation, have shown promise as add-on therapies to standard rehabilitation for improving recovery after ischemic stroke by enhancing cortical excitability and promoting neurorepair.

The review highlights the safety and efficacy of various NIBS methods in stroke patients, suggesting that these techniques could significantly aid in functional recovery, although the degree of improvement can vary among individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-invasive brain stimulation as therapeutic approach for ischemic stroke: Insights into the (sub)cellular mechanisms. Kemps, H., Gervois, P., Brône, B., et al.[2022]

Vagus nerve stimulation (VNS) therapy has been implanted in over 16,000 patients and has become a significant treatment option for seizures that do not respond to medication, following its FDA approval 5 years ago.

The review highlights the long-term efficacy and safety of VNS therapy, suggesting that it is effective even in special populations and those with co-morbid conditions, while also calling for further studies to explore its full potential.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vagus nerve stimulation therapy summary: five years after FDA approval. Schachter, SC.[2022]

Deep brain stimulation (DBS) shows promise in managing post-stroke maladaptive responses such as pain, dystonia, dyskinesias, and tremor, based on a comprehensive literature review.

While evidence for DBS improving motor deficits after stroke is limited, some studies suggest that targeting the posterior limb of the internal capsule may help improve weakness (paresis) in certain cases, indicating a need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deep brain stimulation for stroke: Current uses and future directions. Elias, GJB., Namasivayam, AA., Lozano, AM.[2018]

In a study of 33 stroke patients and 19 healthy volunteers, it was found that stroke significantly reduces the generation of movement-preparatory low-frequency oscillations (LFOs) in the brain, which are crucial for motor control.

As patients recovered over 1 to 3 months, the re-emergence of LFOs correlated with improvements in motor function, suggesting that therapies aimed at restoring these signals could enhance recovery after a stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-Frequency Brain Oscillations Track Motor Recovery in Human Stroke. Bönstrup, M., Krawinkel, L., Schulz, R., et al.[2020]

Transcutaneous vagus nerve stimulation (tVNS) has shown potential in reducing infarct size in animal models of hyperacute stroke and enhancing neurological recovery in chronic stroke when paired with limb movements.

The review emphasizes the need for further research to better understand the mechanisms of tVNS and to effectively translate its benefits into clinical practice for both acute and chronic stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

tVNS in Stroke: A Narrative Review on the Current State and the Future. Baig, SS., Kamarova, M., Bell, SM., et al.[2023]

Transcranial direct current stimulation (tDCS) is a promising neuromodulation therapy that may help improve outcomes in stroke patients, who face significant challenges in recovery and rehabilitation.

Despite the potential of neuromodulation therapies like tDCS, the mechanisms of stroke recovery and the effectiveness of rehabilitation strategies are not fully understood, highlighting the need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of transcranial direct current stimulation combined with functional task training on motor recovery in stroke patients. Alsharidah, M., Al-Hussain, F., Iqbal, M., et al.[2019]

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. neurologylive.com neurologylive.com/view/helius-pons-neurostimulation-device-advances-stroke-indication-following-registrational-program-data

Helius PoNS Device Advances Stroke Indication Data Helius reported promising results for its Portable Neuromodulation Stimulator, enhancing gait and balance in poststroke patients, with FDA submission planned.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06470009

Study Details | NCT06470009 | Portable Neuromodulation ... Double blind, randomized, placebo controlled, interventional clinical trial investigating the efficacy and safety of PoNS therapy on improving dynamic gait and ...

4. neuronewsinternational.com neuronewsinternational.com/helius-announces-us-fda-510k-submission-for-pons-device-label-expansion-in-stroke/

Helius announces US FDA 510(k) submission for PoNS ... The efficacy and safety of PoNS were clinically established from three clinical trials across 10 sites and 159 enrolled chronic stroke survivors ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7708191/

Portable neuromodulation for motor function recovery Neuromodulation through prolonged translingual stimulation has been shown to positively improved rehabilitation treatment outcomes, particularly balance and ...

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

PoNS Therapy for Stroke Survivors · Info for Participants What safety data exists for PoNS Therapy for stroke survivors? The provided research does not directly address the safety data for PoNS Therapy or Portable ...

7. 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® ... PoNS efficacy and safety was clinically established from three clinical trials across 10 sites and 159 enrolled chronic stroke survivors with ...

8. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06336720/ponsr-therapy-for-gait-and-balance-deficits-in-chronic-stroke-survivors-a-single-arm-study

PoNS® Therapy for Gait and Balance Deficits in Chronic ... Primary Objective: To further evaluate the aspects of safety related to PoNS therapy in chronic stroke survivors.

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

Cranial Nerve Noninvasive Neuromodulation in Adults With ... A portable neuromodulation stimulation (PoNS) device rests on the tongue and stimulates cranial nerves V and VII (trigeminal and facial nerves, respectively).