Cionic Neural Sleeve Multistim Sys… for Parkinson's (NCT07284823)
Improve gait with Cionic Sleeve
- Trial ID
- NCT07284823
- Official Title
- Safety and Usability of the Cionic Neural Sleeve for Parkinson's Disease
- Goal
- Improve gait with Cionic Sleeve
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Cionic, Inc.
- Study Type
- INTERVENTIONAL
- Enrollment
- 10 participants
- Conditions
- Parkinson Disease (PD)
- Interventions
- Cionic Neural Sleeve Multistim System
Summary For Families
The goal is to see whether the Cionic Neural Sleeve can be used safely and easily to help people with Parkinson's who have trouble with gait and walking. The sleeve is a wearable device that sends timed electrical stimulation to leg muscles via a smartphone-connected unit, helping lift the foot and coordinate steps to improve walking mechanics; it is not a drug and does not change how levodopa works, so it can be used alongside usual Parkinson's medications. They are enrolling adults 22 to 75 with self-reported gait impairment who can walk for about one minute, have a compatible smartphone and legs that fit the sleeve, while excluding people with daily falls, implanted pacemakers or defibrillators, leg tumors or thrombosis, or recent leg fractures.
Locations
- Adapt Movement, Carlsbad, California, United States
- CIONIC, San Francisco, California, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Cionic Neural Sleeve Multistim System. The goal is to see whether the Cionic Neural Sleeve can be used safely and easily to help people with Parkinson's who have trouble with gait and walking. The sleeve is a wearable device that sends timed electrical stimulation to leg muscles via a smartphone-connected unit, helping lift the foot and coordinate steps to improve walking mechanics; it is not a drug and does not change how levodopa works, so it can be used alongside usual Parkinson's medications. They are enrolling adults 22 to 75 with self-reported gait impairment who can walk for about one minute, have a compatible smartphone and legs that fit the sleeve, while excluding people with daily falls, implanted pacemakers or defibrillators, leg tumors or thrombosis, or recent leg fractures.
- Who can participate?
- Participants must be between 22 Years and 75 Years.
- Where is this trial located?
- This trial is recruiting at 2 locations.
- Does it cost anything to join?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This trial is estimated to last approximately 1 year.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
- Will I get a placebo in this trial?
- Everyone in this trial receives the experimental treatment. There is no placebo group.