Active not recruitingNAINTERVENTIONAL

Clinical Trial for Near Infrared Endoventricular Illumination for Neuroprotection in Very Early Cases of Parkinson's Disease (Ev-NIRT)

This study called Ev-NIRT is looking for a new way to treat Parkinson's disease. Current treatments help with symptoms but don't slow down the disease itself. Researchers are testing a medical device that shines special near-infrared light directly into the brain. Based on earlier studies, they hope this light might protect brain cells and slow the disease's progression. This first-stage study will involve 7 people with very early Parkinson's to check if the surgery to implant the device is safe and if the light treatment is well-tolerated. Patients will be monitored for four years to also begin looking at the treatment's effects on the disease.

At a glance

Status

Active not recruiting

Phase

Sponsor

University Hospital, Grenoble

Enrolment target

Start

14 Dec 2020

Estimated completion

01 Apr 2032

Very Early Stage of Parkinson's Disease

What is this study about?

Parkinson's disease is a condition that affects the brain, causing problems with movement like trembling, stiffness, and difficulty with balance. While there are treatments available that help manage these symptoms, they don't actually stop the disease from getting worse over time. Currently, there's no treatment that can protect the brain cells that are damaged in Parkinson's.

Researchers have been experimenting with a new idea: using a special type of light, called near-infrared light, to potentially slow down the processes in the brain that lead to Parkinson's. Early tests in laboratories have shown promise that this light could help protect brain cells from further damage. This study aims to see if this promising idea can work safely in people.

To do this, a new medical device called Ev-NIRT has been developed. This device is designed to deliver near-infrared light directly to a very specific area deep inside the brain that is affected by Parkinson's. This initial study is very important because it's the first time this device and treatment approach will be used in humans. Researchers will carefully observe a small group of patients to ensure that the surgery to implant the device is safe and that the brain tolerates the light treatment well. They will also start to look for early signs that the treatment might be slowing down the disease.

Key takeaways

This is a new, early-stage study testing a device that shines light into the brain.
The goal is to see if this light can slow down Parkinson's disease, not just treat symptoms.
It involves brain surgery to implant the device, followed by four years of monitoring.
The study will first check the safety and tolerability of the procedure and device.
Only people with very early-stage Parkinson's (diagnosed in the last two years) can join.

Who may be eligible?

The study is looking for a small number of people who have been recently diagnosed with Parkinson's disease. You would need to be between 25 and 65 years old and have very early-stage Parkinson's, meaning you were diagnosed within the last two years and haven't started Parkinson's medication yet. Your symptoms should also be quite mild.

Certain health conditions or situations would mean you cannot join the study. For example, if you are pregnant or breastfeeding, have had certain cancers recently, or have uncontrolled medical issues, you would not be eligible. If you've had certain brain infections, have medical conditions that make brain surgery risky, or if MRI scans are not suitable for you, you also wouldn't be able to take part.

You'll also need to be able to understand and speak French well, as that's the language of the study. A doctor would do a full check to make sure you meet all the requirements and that it's safe for you to consider joining.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Have I been diagnosed with Parkinson's within the last two years?
Am I between 25 and 65 years old?
Have I not started any specific Parkinson's medication yet?
Do I speak and understand French easily?
Do I have a generally good health, without other serious uncontrolled medical conditions?
Am I comfortable with the idea of brain surgery and regular brain scans?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be one of seven patients in this study. It involves a surgical procedure to implant the small medical device into your brain. This device will then deliver the near-infrared light. The light treatment would start immediately after your surgery.

You would have regular follow-up visits and tests over four years. These would include special brain scans called PET scans, which help researchers see how brain cells are doing. These scans will be done once a year for four years, plus one at the very beginning of the study. These will be compared to a group of 7 similar Parkinson's patients who do not receive the implant or light treatment. The study will look closely at how safe the surgery and light treatment are, and how well your body tolerates them. Throughout the four years, your medical team will monitor you closely.

Potential risks and benefits

As this is a new treatment, the potential benefits are not yet fully known. However, researchers hope that the near-infrared light treatment could help protect brain cells and slow down the progression of Parkinson's disease, which no current treatments can do. There are risks involved with any surgery, including brain surgery, such as infection or bleeding. There might also be risks associated with living with an implanted device or with the light treatment itself, which will be carefully monitored. You will be fully informed of all known and potential risks before you decide to participate, and you have the right to withdraw from the study at any time.

Locations (1)

CLINATEC
Verified postcode
Grenoble, France

Common questions

What is near-infrared light and how might it help?

Near-infrared light is a type of light that isn't visible to the human eye. Early studies suggest it might help protect brain cells from damage and could potentially slow down conditions like Parkinson's.

Will I feel the light inside my brain?

No, you will not feel the light. The device is designed to deliver a specific type of light directly to brain cells, and this process doesn't cause any sensation you would notice.

Is the surgery safe?

All surgeries carry some risks. In this study, the surgery involves implanting a small device into the brain. The medical team has experience with similar procedures, and they will carefully assess if it's safe for you. They will explain all potential risks before you decide to take part.

What is a PET scan and why do I need it?

A PET scan is a type of medical imaging that helps doctors see how your brain cells are working. For this study, it helps researchers monitor the health of specific brain cells that are affected by Parkinson's disease over time, to see if the treatment has an effect.

What if I decide the study isn't for me?

Your participation is completely voluntary. You have the right to leave the study at any time, for any reason, without it affecting your medical care.