Optical Coherence Tomography (OCT)… for Parkinson's (NCT07720765)
Can retinal scans track Parkinson
- Trial ID
- NCT07720765
- Official Title
- A National, Monocentric, Prospective Cohort Study to Evaluate the Utility and Applicability of Optical Coherence Tomography in Neurological Clinical Practice
- Goal
- Can retinal scans track Parkinson
- Status
- RECRUITING
- Sponsor
- IRCCS San Raffaele
- Study Type
- OBSERVATIONAL
- Enrollment
- 1050 participants
- Conditions
- Multiple Sclerosis, Alzheimer Disease, Parkinson Disease, Migraine, Headache Disorders
- Interventions
- Optical Coherence Tomography (OCT) - Heidelberg SPECTRALIS HRA+OCT
Summary For Families
They are looking at whether a quick, non-invasive eye scan can help diagnose and monitor Parkinson's by measuring small changes in the thickness of the retina over time. The test is optical coherence tomography, or OCT, a clinically approved imaging device that automatically and reliably measures different retinal layers; scans are done at the start and at 6, 12, 18, and 24 months, and those retinal measurements will be compared with standard movement scores (the UPDRS), brain scans, and lab markers. Adults with Parkinson's who are 18 or older and able to attend the visits may join, provided they do not have other eye disease that would affect the results and can follow study instructions. Because loss of retinal nerve cells has been seen in Parkinson's, the team hopes OCT could become an accessible, repeatable tool to help with diagnosis and tracking over time.
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.
- Disease stage: Stage 1 on the Hoehn and Yahr scale
- Healthy volunteers: Also accepts people without Parkinson's (healthy volunteers) (criteria text: "CT.gov structured field: healthyVolunteers")
Locations
- IRCCS Ospedale San Raffaele - Neurology and Neurophysiology Unit, Milan, Milano, Italy
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 NCT07720765. It is the one about "Can retinal scans track Parkinson". 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: Participants will undergo OCT at baseline and at 6, 12, 18, and 24 months of follow-up. 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 is an observational study, so there is no placebo and no experimental treatment is assigned. Researchers observe and collect information while you continue your usual care. Ask the coordinator to confirm it still applies.
- 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 Optical Coherence Tomography (OCT) - Heidelberg SPECTRALIS HRA+OCT. They are looking at whether a quick, non-invasive eye scan can help diagnose and monitor Parkinson's by measuring small changes in the thickness of the retina over time. The test is optical coherence tomography, or OCT, a clinically approved imaging device that automatically and reliably measures different retinal layers; scans are done at the start and at 6, 12, 18, and 24 months, and those retinal measurements will be compared with standard movement scores (the UPDRS), brain scans, and lab markers. Adults with Parkinson's who are 18 or older and able to attend the visits may join, provided they do not have other eye disease that would affect the results and can follow study instructions. Because loss of retinal nerve cells has been seen in Parkinson's, the team hopes OCT could become an accessible, repeatable tool to help with diagnosis and tracking over time.
- Who can participate?
- Participants must be at least 18 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- 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 6 years and 6 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 is an observational study, so there is no placebo and no experimental treatment is assigned. Researchers observe and collect information while you continue your usual care.
- How many visits does this trial involve?
- Participants will undergo OCT at baseline and at 6, 12, 18, and 24 months of follow-up.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: MRI scan (non-invasive); Thinking & memory tests (non-invasive). Confirm the full schedule with the study coordinator.