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

Chronic Stroke Survivors Clinical Trial

Official title:

Portable Neuromodulation Stimulator (PoNS®) Therapy for Gait and Balance Deficits in Chronic Stroke Survivors: A Single-Arm Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06336720
• Other study ID #: HMI-SA-PoNS-STK001
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: May 1, 2024
• Est. completion date: August 30, 2025

Study information

• Verified date: March 2024
• Source: Helius Medical Inc
• Contact: Mark Bowden
• Phone: 904.345.6626
• Email: Mark.Bowden[@]Brooksrehab.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Men and women = 18 and < 85 years of age with a diagnosis ischemic or hemorrhagic stroke 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 device and perform the rehabilitation exercise program.

Exclusion Criteria:

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

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 the tongue.

4. Diagnosis of dementia or mild cognitive impairment

5. Concurrent daily use of transcutaneous electric nerve stimulation (TENS) and/or other 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.

Related Conditions & MeSH terms

• Chronic Stroke Survivors
• Stroke

Intervention

Device:
• Portable Neuromodulation Stimulator (PoNS)
The active PoNS device delivers amplitude-controlled, biphasic pulses to the anterior superior surface of the tongue through gold-plated electrodes.

Locations

Country	Name	City	State
United States	Shepherd Center	Atlanta	Georgia
United States	Neurology Center of New England, P.C.	Foxboro	Massachusetts
United States	Brooks Rehabilitation	Jacksonville	Florida
United States	Rehabologym Corp	Tarrytown	New York

Sponsors (1)

Lead Sponsor	Collaborator
Helius Medical Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary safety endpoints	treatment - related serious adverse events (SAE) over 12 week treatment	12 week