Cionic Neural Sleeve safety and ease of use for Parkinson's gait
Safety and Usability of the Cionic Neural Sleeve for Parkinson's Disease
This test will see if the Cionic Neural Sleeve Multistim System is safe and easy to use for people with Parkinson's who have trouble walking.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 22 Years to 75 Years |
| Sex | All |
| Sponsor | Cionic, Inc. Industry-sponsored |
| Locations | 2 sites (Carlsbad, California and 1 other locations) |
| Trial ID | NCT07284823 on ClinicalTrials.gov |
What this trial studies
This interventional study will have people with Parkinson's and self-reported gait impairment try the Cionic Neural Sleeve Multistim System, a wearable device that delivers stimulation to the legs. Participants must be able to walk for up to one minute and have a compatible smartphone with Bluetooth and internet access to run the device. The study focuses on safety outcomes and usability metrics rather than long-term efficacy, and excludes people with daily falls, implanted demand-type pacemakers or defibrillators, or certain leg conditions. Visits are conducted at two California sites where device fitting and monitoring will occur.
Who should consider this trial
Good fit: Ideal candidates are people with Parkinson's who report gait problems, can walk for about one minute (with or without an assistive device), fit the sleeve's sizing, and own a compatible smartphone with Bluetooth and internet.
Not a fit: People who fall daily, have implanted demand-type pacemakers or defibrillators, leg tumors/thrombosis, recent leg fractures or dislocations, or who cannot use a compatible smartphone or do not fit the sleeve sizing are unlikely to be eligible or benefit.
Why it matters
Potential benefit: If successful, the device could offer a safe, wearable way to improve walking comfort and mobility for people with Parkinson's.
How similar studies have performed: Wearable electrical stimulation approaches for Parkinson's gait have shown some promising but mixed results in prior work, while this specific multistim sleeve is a newer, less extensively studied device.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Self-reported gait impairment * Have access to a smartphone with iOS or Android operating system with Bluetooth capabilities and internet connection * Ability to walk with or without an assistive device for up to 1 minute * Leg measurements within sizing range of the Cionic Neural Sleeve Exclusion Criteria: * Daily occurrence of falls * Implanted demand-type cardiac pacemaker or defibrillator * Malignant tumor or existing thrombosis in the leg * Fracture or dislocation in the leg that could be adversely affected by motion from stimulation
Where this trial is running
Carlsbad, California and 1 other locations
- Adapt Movement — Carlsbad, California, United States (Recruiting)
- Cionic — San Francisco, California, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.