Relieve movement symptoms between doses
- Trial ID
- NCT07400731
- Official Title
- Multicenter Study of Safety and Effectiveness of Auricular Muscle Zone Stimulation With the EarStim Novel Device for Parkinson's Disease
- Goal
- Relieve movement symptoms between doses
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Stoparkinson Healthcare Systems LLC
- Study Type
- INTERVENTIONAL
- Enrollment
- 90 participants
- Conditions
- PARKINSON DISEASE (Disorder)
- Interventions
- EarStim, Sham device, EarStim + Standard of care (SOC), Standard of Care (SOC)
Summary For Families
Aiming to reduce OFF time and improve motor function during OFF periods for people with Parkinson's who still get ON/OFF fluctuations despite levodopa. EarStim delivers mild electrical pulses to muscles around the ear to influence brain movement circuits, it is used with your regular carbidopa/levodopa and is meant to boost motor control without changing medication doses. Looking for adults 44 and up on a stable carbidopa/levodopa regimen who have measurable ON/OFF swings, can walk without assistance, are willing to keep meds unchanged for the 90-day study and tolerate up to three hours in an OFF state, and who do not have implanted stimulators, certain cardiac or seizure disorders, or use on-demand rescue infusions or apomorphine.
Locations
- Koc University Hospital, Istanbul, Turkey (Türkiye)
- Şişli Hamidiye Etfal Research and Training Hospital, Istanbul, Turkey (Türkiye)
Frequently Asked Questions
- What is this trial testing?
- This trial is studying EarStim. Aiming to reduce OFF time and improve motor function during OFF periods for people with Parkinson's who still get ON/OFF fluctuations despite levodopa. EarStim delivers mild electrical pulses to muscles around the ear to influence brain movement circuits, it is used with your regular carbidopa/levodopa and is meant to boost motor control without changing medication doses. Looking for adults 44 and up on a stable carbidopa/levodopa regimen who have measurable ON/OFF swings, can walk without assistance, are willing to keep meds unchanged for the 90-day study and tolerate up to three hours in an OFF state, and who do not have implanted stimulators, certain cardiac or seizure disorders, or use on-demand rescue infusions or apomorphine.
- Who can participate?
- Participants must be at least 44 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 10 months.
- 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.