PoNS Therapy for Stroke Survivors

Not currently recruiting at 2 trial locations

Overseen By Murielle Grangeon, PhD, Adm. A

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Helius Medical Inc

Disqualifiers: Neurological disorders, Dementia, Cancer, Pregnancy, 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the Portable Neuromodulation Stimulator (PoNS) to determine its effectiveness in improving walking and balance in stroke survivors. The study compares the effects of the actual device against a placebo, which looks identical but lacks active treatment. Individuals who experienced a stroke over six months ago and have difficulty walking might be suitable for this trial. Participants should be able to walk at least 10 feet and understand how to use the PoNS device.

As an unphased study, this trial provides a unique opportunity to explore innovative treatment options for stroke recovery.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot use transcutaneous electric nerve stimulation (TENS) or other peripheral stimulation devices daily, and you should not have had neurostimulation therapy in the past 6 months.

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 those using certain stimulation devices and those who have had neurostimulation therapy in the past 6 months.

What prior data suggests that the Portable Neuromodulation Stimulator (PoNS) is safe for stroke survivors?

Research has shown that the Portable Neuromodulation Stimulator (PoNS) may help stroke survivors improve walking and balance. However, specific safety information for this therapy is not yet available. As PoNS remains under study, the trial phase is labeled "not applicable," indicating that detailed safety data is still being collected.

In other studies, PoNS has been used in various situations and has shown positive results, though specific side effects or negative reactions are not detailed. This suggests that while the treatment is still being researched, it might be generally well-tolerated. Potential participants should be aware that complete safety information is still being gathered. It is important to consult a healthcare provider about any concerns before joining a trial. ^{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 new approach through translingual neurostimulation. Unlike traditional rehabilitation methods that focus primarily on physical therapy and medication, this technique stimulates the brain via the tongue to enhance neural plasticity and recovery. By using a portable neuromodulation device, PoNS Therapy provides a non-invasive and potentially faster way to improve motor function and balance, offering hope for those who have limited success with conventional treatments.

What evidence suggests that PoNS therapy is effective for improving gait and balance in stroke survivors?

This trial will compare the effectiveness of the Portable Neuromodulation Stimulator (PoNS) with a sham comparator for stroke recovery. Studies have shown that PoNS can effectively aid stroke survivors in improving walking and balance. In trials with 159 stroke survivors, many participants experienced positive changes in their ability to walk and maintain balance after using PoNS. The device sends gentle electrical signals to the brain through the tongue, facilitating neuroplasticity, which helps the brain rewire itself. These findings are promising, suggesting PoNS could be a useful tool for stroke recovery. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for chronic stroke survivors who have ongoing difficulties with walking and balance. Participants must meet certain health criteria to join, but specific inclusion and exclusion details are not provided here.

Inclusion Criteria

Montreal Cognitive Assessment 5-min (MoCA 5-min) score of 6 or higher.

I have weakness in my leg with a specific test score below 34.

FGA score less than 23 at screening.

Exclusion Criteria

Sensitivity to nickel, gold, or copper.

I have received cancer treatment in the last year.

I have severe arthritis or orthopedic issues that restrict my movement.

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 program combined with active or sham device's study treatment in clinic

4 weeks

Weekly visits (in-person)

Treatment Part 2

Participants continue DGB training program at home, mostly unsupervised, with weekly follow-ups in clinic

8 weeks

Weekly follow-ups (in-person)

Follow-up

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

12 weeks

Final assessment visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Portable Neuromodulation Stimulator (PoNS)

Trial Overview The study is testing the Portable Neuromodulation Stimulator (PoNS) device to see if it helps improve gait and balance in people who have had a stroke. It's a double-blind study, meaning neither the researchers nor participants know who gets the real treatment or a placebo.

How Is the Trial Designed?

Group I: Arm 2 Active Control 1 Intervention

administration of translingual neurostimulation.

Group II: Arm 1 Placebo Group 1 Intervention

administration of translingual neurostimulation.

Portable Neuromodulation Stimulator (PoNS) is already approved in United States, Canada for the following indications:

Approved in United States as PoNS for:

• Gait deficit due to mild to moderate symptoms from multiple sclerosis

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 (mmTBI)
• Gait deficit due to mild and moderate symptoms from multiple sclerosis

Who Is Running the Clinical Trial?

Helius Medical Inc

Lead Sponsor

Trials

10

Recruited

370+

Published Research Related to This Trial

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]

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]

A systematic review of 38 randomized controlled trials involving 1261 participants found that transcutaneous vagus nerve stimulation (tVNS) and anodal transcranial direct current stimulation (tDCS) significantly improve upper limb motor function and activities of daily living (ADL) after stroke.

tVNS was ranked as the most effective treatment for enhancing motor function and ADL performance, with no significant safety concerns compared to control interventions, indicating its potential as a safe and effective rehabilitation strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Adjunct of Electric Neurostimulation to Rehabilitation Approaches in Upper Limb Stroke Rehabilitation: A Systematic Review With Network Meta-Analysis of Randomized Controlled Trials. Ahmed, I., Yeldan, I., Mustafaoglu, R.[2022]

A new technique for repositioning supraorbital electrodes in peripheral nerve stimulation (PNS) has been developed, which uses retrograde needle insertion to minimize tissue injury and complications.

This method has been successfully applied in multiple cases, providing a simpler and less invasive alternative to traditional electrode repositioning procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repositioning of supraorbital nerve stimulation electrode using retrograde needle insertion: a technical note. Slavin, KV., Vannemreddy, PS.[2022]

Peripheral nerve stimulation (PNS) has rapidly evolved as a versatile treatment for various types of pain, utilizing percutaneous leads for easier and less invasive implantation since its introduction in 1999.

Current research is exploring PNS for broader applications beyond pain management, including conditions like epilepsy and obesity, with advancements in technology expected to enhance safety and accessibility for clinicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peripheral neuromodulation: a review. Goroszeniuk, T., Pang, D.[2021]

Peripheral nerve stimulation (PNS) has been effectively used since the 1960s to treat various painful conditions, showcasing its long-standing efficacy as a neuromodulation technique.

The field of PNS is rapidly evolving, with ongoing advancements in technology and procedures that enhance its clinical applications and effectiveness in pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

History of peripheral nerve stimulation. Slavin, KV.[2019]

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]

Stroke is a leading cause of death and disability, with many patients requiring rehabilitation due to incomplete recovery; noninvasive brain stimulation techniques like rTMS and tES show promise in enhancing neuroplasticity and recovery.

New neuromodulation options, such as vagal nerve stimulation (both invasive and noninvasive) and extremely low-frequency magnetic fields, are being explored to improve neuroprotection and recovery outcomes in stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New tools for shaping plasticity to enhance recovery after stroke. Motolese, F., Capone, F., Di Lazzaro, V.[2022]

Vagus nerve stimulation (VNS) is effective for treating refractory epilepsy and depression, but traditional methods involve surgical implantation, which carries risks such as infection and bradycardia.

New non-invasive VNS systems eliminate the need for surgery, improving safety and tolerability, and allowing patients to administer stimulation on demand, potentially expanding its use in various medical conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgically implanted and non-invasive vagus nerve stimulation: a review of efficacy, safety and tolerability. Ben-Menachem, E., Revesz, D., Simon, BJ., et al.[2022]

A new training curriculum for Peripheral Nerve Stimulation (PNS) has been developed by a multidisciplinary task force to standardize education and improve proficiency in this effective treatment for chronic pain.

The curriculum includes defined milestones for learners at different levels (early, advanced, and practitioner) and covers essential skills such as professionalism, medical knowledge, and procedural skills, ensuring comprehensive training in PNS therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Educational Curriculum for Peripheral Nerve Stimulation Developed by the North American Neuromodulation Society. Kalia, H., Abd-Elsayed, A., Malinowski, M., et al.[2023]

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]

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]

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 ... Double blind, randomized, placebo controlled, interventional clinical trial investigating the efficacy and safety of PoNS therapy on improving dynamic gait and ...

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

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

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 induces neuroplasticity to re ... Neuromodulation through prolonged translingual stimulation has been shown to positively improved rehabilitation treatment outcomes, particularly balance and ...

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

Cranial Nerve Noninvasive Neuromodulation in Adults With ... Translingual Neural Stimulation With the Portable Neuromodulation Stimulator (PoNS®) Induces Structural Changes Leading to Functional Recovery In Patients With ...

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 ...