EarStim for Parkinson's (NCT07400731)
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.
Eligibility at a Glance
Key requirements found in this trial's official criteria, in plain language. Only what the listing states is shown; the study team makes the final call.
- Levodopa: Must be taking levodopa (criteria text: "* subject has pd and is on stable carbidopa/levodopa therapy for at least four weeks prior to enrollment in the study")
- Movement score (MDS-UPDRS): MDS-UPDRS movement score of at least 1 (criteria text: "* subject reports experiencing both "on" and "off" episodes (mds-updrs part iv - time spent in the off-state score >=1), as assessed and determined by the in...")
Locations
- Koc University Hospital, Istanbul, Turkey (Türkiye)
- Şişli Hamidiye Etfal Research and Training Hospital, Istanbul, Turkey (Türkiye)
Making Contact: How to Call This Study Site
Who to ask for
Ask for the study coordinator. Some sites call this person the research coordinator. They are the right person for questions about joining a study. If you reach a front desk or a doctor's office scheduler, ask them to connect you with the research team for this study.
What to say
It is fine to read this out loud, word for word:
Hello, my name is ____. I am calling about a Parkinson's study at your site. The study number is NCT07400731. It is the one about "Relieve movement symptoms between doses". Could I speak with the study coordinator about taking part?
If you are calling for a family member, use their name and mention that you help with their care.
What they will ask you
- The year of diagnosis
- Current medications and their doses
- Other health conditions
- Any procedures already done, such as deep brain stimulation (DBS)
- How far you are able to travel for study visits
- Whether a care partner can come to visits with you
What to have ready
- A written list of current medications and doses
- Your neurologist's name and phone number
- The diagnosis date. The year is enough.
- A recent visit summary from the neurologist, if you have one
What to ask them
- How many visits are there, and how long does each visit take? The listing already answers this: One clinical visit (Visit 1, Day 0) for Period A, and Period B involves home use over a 90-day period. Ask the coordinator to confirm it still applies.
- Is travel, parking, or my time reimbursed?
- Is there a placebo group, and what is my chance of being in it? The listing already answers this: This trial has 2 groups, and 1 is a sham (a pretend version of the procedure) group. Because assignment is random, you have about a 1 in 2 chance (roughly 50%) of being in the sham group, assuming the groups are filled equally. Ask the coordinator to confirm the exact assignment ratio.
- Would I need to stop or pause any of my current medications?
- What happens when the study ends? Could I stay on the treatment if it helps?
What to expect
- Expect to wait a few days for a callback. A week is common. Calling or emailing again after that is fine and normal.
- Many callers do not end up joining. Screening out is common and is not a judgment about you or your health.
- Asking questions commits you to nothing. You can stop the process at any point.
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?
- 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 10 months.
- 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?
- This trial has 2 groups, and 1 is a sham (a pretend version of the procedure) group. Because assignment is random, you have about a 1 in 2 chance (roughly 50%) of being in the sham group, assuming the groups are filled equally. Ask the coordinator to confirm the exact assignment ratio.
- How many visits does this trial involve?
- One clinical visit (Visit 1, Day 0) for Period A, and Period B involves home use over a 90-day period.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Brain surgery / implanted device (invasive); Wearable / at-home monitoring (non-invasive). Confirm the full schedule with the study coordinator.