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

60 Participants Needed

Trial Summary

What is the purpose of this trial?

Portable Neuromodulation Stimulator (PoNS) is non-invasive stimulation device placed on the tongue to stimulate those brain regions understood to be important for maintaining balance. This research study aims to collect evidence that PoNS therapy along with balance training improves postural and walking stability post-stroke.

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 data supports the effectiveness of this treatment for stroke patients?

Research shows that local vibration and peripheral somatosensory stimulation (PSS) can improve balance and postural stability in stroke patients. PSS, when combined with exercises, has been found to promote long-term postural recovery, suggesting that similar neuromodulation techniques could be beneficial in stroke rehabilitation. ^{1 2 3 4 5}

Is neuromodulation combined with balance training safe for humans?

Research on neuromodulation devices like the Portable Neuromodulation Stimulator (PoNS) and other similar technologies shows they are generally safe for humans, with no severe adverse events reported in studies. Some minor side effects, like slight skin redness, have been observed, but overall, these treatments have been used safely in various rehabilitation settings. ^{6 7 8 9 10}

How is the PoNS treatment different from other stroke treatments?

The PoNS treatment is unique because it uses a device to stimulate the cranial nerves (nerves in the head) non-invasively, which helps improve balance and walking by promoting changes in the brain's neural pathways. This approach is different from traditional therapies that might focus solely on physical exercises or medications. ^{1 4 5 6 11}

Research Team

Steven Kautz, PhD

Principal Investigator

Medical University of South Carolina

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

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]

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 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]

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]

References

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

Immediate Effects of Plantar Vibration on Fall Risk and Postural Stability in Stroke Patients: A Randomized Controlled Trial. [2020]

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

The Effects of Vestibular Rehabilitation on Gait Performance in Patients with Stroke: A Systematic Review of Randomized Controlled Trials. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Peripheral somatosensory stimulation and postural recovery after stroke - a systematic review. [2018]

4. Korea (South) pubmed.ncbi.nlm.nih.gov

The effects of visual and haptic vertical stimulation on standing balance in stroke patients. [2021]

5. England 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. [2016]

6. England 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. [2022]

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

Vagus Nerve Stimulation Paired With Upper Limb Rehabilitation After Chronic Stroke. [2019]

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

Visually-Induced Motor Imagery Effects on Motor Adaptation to Reverse Steering Cycling. A Randomized Controlled Trial. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

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

10. England pubmed.ncbi.nlm.nih.gov

Designing and pilot testing a novel high-definition transcranial burst electrostimulation device for neurorehabilitation. [2022]

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

Effect of Wii-based balance training on corticomotor excitability post stroke. [2022]