Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-25 @ 4:27 AM
NCT ID:
NCT06336720
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT06336720
Study Brief:
Protocol Section:
NCT06336720