Link hormones with motor fluctuations
- Trial ID
- NCT06582212
- Official Title
- Enabling Women with Parkinson's Disease to Identify and Better Manage Hormonal Triggers
- Goal
- Link hormones with motor fluctuations
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- University Hospital, Grenoble
- Study Type
- INTERVENTIONAL
- Enrollment
- 100 participants
- Conditions
- Digital Technology, Mobile Application, Motor Fluctuations, Oestrogen, Parkinson Disease
- Interventions
- Mymovesmatter mobile application
Summary For Families
The trial is helping women with Parkinson's see whether hormonal changes are linked to motor fluctuations, so they can better predict and manage symptom ups and downs. Participants use the Mymovesmatter mobile app to track menstrual cycles, hormonal treatments like OCP or IUD, and daily motor symptoms, and the app looks for patterns that could inform timing of levodopa or other treatment and lifestyle discussions with clinicians; the app itself does not change medications. It's enrolling non-menopausal women aged 18 to 56 with Parkinson's diagnosed at least two years ago who are on a stable PD medication regimen and able to give informed consent; post-menopausal women and those with conditions preventing safe participation are excluded.
Locations
- CHU Grenoble Alpes, Grenoble, Grenoble, France
- CHU Nantes Hôpital Laennec, Nantes, France
- CHU Rennes -Site Pontchaillou, Rennes, France
- Chu Toulouse, Toulouse, France
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Mymovesmatter mobile application. The trial is helping women with Parkinson's see whether hormonal changes are linked to motor fluctuations, so they can better predict and manage symptom ups and downs. Participants use the Mymovesmatter mobile app to track menstrual cycles, hormonal treatments like OCP or IUD, and daily motor symptoms, and the app looks for patterns that could inform timing of levodopa or other treatment and lifestyle discussions with clinicians; the app itself does not change medications. It's enrolling non-menopausal women aged 18 to 56 with Parkinson's diagnosed at least two years ago who are on a stable PD medication regimen and able to give informed consent; post-menopausal women and those with conditions preventing safe participation are excluded.
- Who can participate?
- Participants must be between 18 Years and 56 Years.
- Where is this trial located?
- This trial is recruiting at 4 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 2 years.
- 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.