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

Running, not enrolling · Not applicable

Conditions studied: Chronic Stroke Survivors

In brief

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.

Key facts

Study ID

NCT06336720

Run by

Helius Medical Inc

People needed

30

Starts

2024-05-01

Expected to finish

2026-09-30

Last updated by the study team

2026-01-08

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men and women ≥ 18 and < 85 years of age with a diagnosis ischemic or hemorrhagic stroke at > 6 months since stroke onset event.
• FMA-LE scores < 34 at screening with residual paresis in the lower extremity.
• Able to walk at least 10 feet with or without assistive device.
• FGA score < 23 at screening.
• Montreal Cognitive Assessment 5-min (MoCA 5-min) ≥ 6
• Able to understand, learn and apply instructions on how to operate the PoNS device and perform the rehabilitation exercise program.

You may not qualify if…

• Pre-existing neurological disorders or previous stroke affecting the other hemisphere.
• Severe arthritis or orthopedic problems that limit passive range of motion.
• Areas of recent bleeding or open wounds; or areas that lack normal sensation on the tongue.
• Diagnosis of dementia or mild cognitive impairment
• Concurrent daily use of transcutaneous electric nerve stimulation (TENS) and/or other peripheral stimulation devices (i.e. Bioness®)
• Neurostimulation therapy over the previous 6 months
• Cancer treatment within the past year.
• Nonremovable metal orthodontic devices.
• Oral health problems.
• Chronic infectious diseases.
• Pregnancy.
• Sensitivity to nickel, gold or copper.

Where it is running

• Brooks Rehabilitation — Jacksonville, Florida, United States
• Shepherd Center — Atlanta, Georgia, United States
• MGH Institute of Health Professions — Boston, Massachusetts, United States
• Neurology Center of New England, P.C. — Foxborough, Massachusetts, United States
• Rehabologym Corp — Tarrytown, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.