PoNS® Therapy for Gait and Balance Deficits in Chronic Stroke Survivors: a Single-Arm Study

Last updated: March 25, 2025
Sponsor: Helius Medical Inc
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Stroke

Cerebral Ischemia

Treatment

Portable Neuromodulation Stimulator (PoNS)

Clinical Study ID

NCT06336720
HMI-SA-PoNS-STK001
  • Ages 18-85
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Men and women ≥ 18 and < 85 years of age with a diagnosis ischemic or hemorrhagicstroke at > 6 months since stroke onset event.

  2. FMA-LE scores < 34 at screening with residual paresis in the lower extremity.

  3. Able to walk at least 10 feet with or without assistive device.

  4. FGA score < 23 at screening.

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

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

Exclusion

Exclusion Criteria:

  1. Pre-existing neurological disorders or previous stroke affecting the otherhemisphere.

  2. Severe arthritis or orthopedic problems that limit passive range of motion.

  3. Areas of recent bleeding or open wounds; or areas that lack normal sensation on thetongue.

  4. Diagnosis of dementia or mild cognitive impairment

  5. Concurrent daily use of transcutaneous electric nerve stimulation (TENS) and/orother peripheral stimulation devices (i.e. Bioness®)

  6. Neurostimulation therapy over the previous 6 months

  7. Cancer treatment within the past year.

  8. Nonremovable metal orthodontic devices.

  9. Oral health problems.

  10. Chronic infectious diseases.

  11. Pregnancy.

  12. Sensitivity to nickel, gold or copper.

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Portable Neuromodulation Stimulator (PoNS)
Phase:
Study Start date:
May 01, 2024
Estimated Completion Date:
August 30, 2025

Study Description

Observational, interventional, single-arm, open label, clinical trial investigating PoNS utilization with combined with dynamic gait and balance rehabilitation exercise (DGB training) in chronic stroke survivors.

6 The data from this prospective, single arm, multi-site, study that will enroll 30 subjects at 3 different clinical sites will be used to augment safety data obtained in the RCT (which will randomize 60 patients 1:1 into either active PoNS combined with DGB training versus DGB training with a sham device). The totality of the proposed clinical evidence spans 3-4 sites and approximately 90 patients.

Eligible study participants in this study will be assigned to treatment with a PoNS device ["active"]. Participants will work with a study physical therapist - trained on PoNS Therapy by HMI Medical and registered as a PoNS Trainer (Trainer). The Trainer will prepare a DGB training exercise program appropriate to the participant's ability level and instruct on how to perform the breathing and awareness (mindfulness) training (BAT). To ensure patient's safety during rehabilitation at home, the Trainer may assign a DGB training program slightly different from the one performed in clinic.

All participants will undergo a total of twelve weeks of DGB training program, performed both in clinic (4 weeks, Part 1), supervised by the Trainer, and at home (8 weeks, Part 2), unsupervised. At the end of the treatment period, they will be asked to return to the clinic site for the follow-up visit 12 weeks after the end of the treatment period, as shown below:

During the training sessions in clinic and, subsequently, during at-home training period, the trainer can adjust /flex the DGB training based on the participant's individual response to PoNS Therapy. During Phase 2, the Trainer will follow-up weekly with participants either in person, or through a telemedicine session, if patient is unavailable to travel to the clinic.

Twelve weeks after completing the 12-week treatment phase of the study, participants will be required to return to the clinic for the final assessment of treatment effect. During the 12-week follow-up period (Part 3), participants will no longer utilize PoNS device but will still be encouraged to continue with their physical rehabilitation program for the duration follow-up period until the final study visit.

Connect with a study center

  • Brooks Rehabilitation

    Jacksonville, Florida 32216
    United States

    Site Not Available

  • Shepherd Center

    Atlanta, Georgia 30309
    United States

    Site Not Available

  • MGH Institute of Health Professions

    Boston, Massachusetts 02129
    United States

    Site Not Available

  • Neurology Center of New England, P.C.

    Foxboro, Massachusetts 02035
    United States

    Site Not Available

  • Rehabologym Corp

    Tarrytown, New York 10591
    United States

    Site Not Available

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