PoNS Therapy for Stroke Survivors

Recruiting at 4 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

30 Participants Needed

Trial Summary

What is the purpose of this trial?

Primary Objective: To further evaluate the aspects of safety related to PoNS therapy in chronic stroke survivors. Secondary Objectives: To further evaluate the efficacy of PoNS on improving dynamic gait and balance, establishing durability of effect, risk of falling and fall rate. As well as adherence to PoNS device utilization. Exploratory Objectives: To further evaluate quality of life to measure physical, mental, behavioral, and general health, as well as functional decline (\> 30% on gait or balance improvement at endpoint) during the 12-week follow-up.

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

Research on neuromodulation techniques, like transcranial direct current stimulation (tDCS), shows promising results in helping stroke patients recover motor function. These techniques, which include PoNS Therapy, aim to stimulate the brain to improve movement and reduce disability after a stroke. ^{1 2 3 4 5}

Is PoNS Therapy safe for humans?

The safety of PoNS Therapy, also known as Portable Neuromodulation Stimulator, has been evaluated in various studies, including those on vagus nerve stimulation (VNS) for stroke recovery. VNS, which is similar in its approach to neuromodulation, has been used safely in thousands of patients for conditions like seizures, suggesting a general safety profile for similar neuromodulation therapies. ^{6 7 8 9 10}

How is PoNS Therapy different from other treatments for stroke recovery?

PoNS Therapy is unique because it uses a non-invasive device to stimulate the tongue, which is believed to help improve brain function and motor recovery in stroke survivors. This approach differs from traditional stroke treatments that often focus on physical rehabilitation or medications, as it directly targets the nervous system to enhance recovery. ^{1 2 3 11 12}

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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) 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]

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]

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]

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]

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]

References

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

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

2. 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]

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

Deep brain stimulation for stroke: Current uses and future directions. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Effect of transcutaneous electrical nerve stimulation (TENS) on Barthel Activities of Daily Living (ADL) index score following stroke. [2022]

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

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

6. England pubmed.ncbi.nlm.nih.gov

Non-invasive brain stimulation as therapeutic approach for ischemic stroke: Insights into the (sub)cellular mechanisms. [2022]

7. 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]

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

tVNS in Stroke: A Narrative Review on the Current State and the Future. [2023]

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

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

10. 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]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Advances in Stroke Neurorehabilitation. [2023]

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

Emerging treatments for motor rehabilitation after stroke. [2022]