PoNS Therapy for Stroke Survivors

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

60 Participants Needed

Trial Summary

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 data supports the idea that PoNS Therapy for Stroke Survivors is an effective treatment?

The available research shows that neuromodulation techniques, like PoNS Therapy, are being explored to help stroke survivors recover motor functions. While specific data on PoNS Therapy isn't provided, other neuromodulation methods, such as Vagus Nerve Stimulation (VNS), have shown positive results in improving motor function in stroke patients. This suggests that PoNS Therapy might also be effective, as it is part of the same category of treatments aimed at enhancing recovery after a stroke. ^{1 2 3 4 5}

What data supports the effectiveness of the PoNS treatment for stroke survivors?

Research on similar neuromodulation techniques, like transcranial direct current stimulation and vagus nerve stimulation, shows promising results in improving motor recovery after a stroke. These studies suggest that neuromodulation can enhance recovery and reduce impairment in stroke patients. ^{1 2 3 4 5}

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 Neuromodulation Stimulator specifically. However, it discusses the safety of related neuromodulation techniques like vagus nerve stimulation (VNS). VNS has been associated with adverse events such as voice alteration, paresthesia, cough, headache, dyspnea, pharyngitis, and pain, which may require adjustments in stimulation. Non-invasive VNS systems have improved safety and tolerability by eliminating the need for surgical implantation. While this information is about VNS, it may provide some context for understanding potential safety considerations in similar neuromodulation therapies. ^{3 5 6 7 8}

Is PoNS Therapy generally safe for humans?

The available research on similar neuromodulation therapies, like peripheral nerve stimulation, suggests that non-invasive methods improve safety and tolerability, reducing risks associated with surgical procedures. ^{6 7 8 9 10}

Is the Portable Neuromodulation Stimulator (PoNS) a promising treatment for stroke survivors?

Yes, the Portable Neuromodulation Stimulator (PoNS) is a promising treatment for stroke survivors. It is part of a new wave of therapies called neuromodulation, which helps the brain recover by stimulating it in specific ways. This approach has shown potential in improving motor function, which is often affected by strokes. ^{1 2 3 11 12}

How is PoNS Therapy different from other stroke treatments?

PoNS Therapy is unique because it uses a portable device to stimulate the tongue, which is thought to help the brain reorganize and improve motor function after a stroke. This approach is different from other treatments that often focus on direct brain stimulation or physical rehabilitation exercises. ^{1 2 3 11 12}

What is the purpose of this trial?

Double blind, randomized, placebo controlled, interventional clinical trial investigating the efficacy and safety of PoNS therapy on improving dynamic gait and balance deficits in chronic stroke survivors.

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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) 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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. Italy pubmed.ncbi.nlm.nih.gov

The effect of transcranial direct current stimulation combined with functional task training on motor recovery in stroke patients. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Neuromodulation for Post-Stroke Motor Recovery: a Narrative Review of Invasive and Non‑Invasive Tools. [2023]

3. Switzerland 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. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Low-Frequency Brain Oscillations Track Motor Recovery in Human Stroke. [2020]

5. England 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. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

History of peripheral nerve stimulation. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Repositioning of supraorbital nerve stimulation electrode using retrograde needle insertion: a technical note. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Surgically implanted and non-invasive vagus nerve stimulation: a review of efficacy, safety and tolerability. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Peripheral neuromodulation: a review. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Educational Curriculum for Peripheral Nerve Stimulation Developed by the North American Neuromodulation Society. [2023]

11. Netherlands pubmed.ncbi.nlm.nih.gov

New tools for shaping plasticity to enhance recovery after stroke. [2022]

12. United States 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. [2022]