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?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 1 year.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- 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.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- 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.