If so, you may be eligible to take part in a clinical trial that will determine whether a non-invasive investigational device improves motor and non-motor symptoms of Parkinson’s.
Parkinson’s disease is an age-related degenerative brain condition that causes part of your brain to deteriorate. Parkinson’s is progressive meaning that symptoms change and tend to get worse over time. While Parkinson’s is mostly known for affecting movement, muscle control and balance, it also causes a wide range of non-motor symptoms that can impact your senses, thinking ability, mental health and more.
The motor (movement-related) symptoms are widely recognized Parkinson’s disease symptoms because they are noticeable from the outside. These “motor” symptoms are what usually lead to the initial diagnosis, but motor symptoms are not the only burden of Parkinson’s.
Non-motor (non-movement) symptoms are sometimes called the “invisible” symptoms of Parkinson’s because they often aren’t noticeable from the outside. However, for many people with Parkinson’s, these non-motor symptoms are as much, or more, of a burden than the motor symptoms.
Studies show that people living with Parkinson’s typically experience multiple different non-motor symptoms at any given time. Unfortunately, Parkinson's non-motor symptoms are not well treated by standard of care treatments for motor symptoms, and existing treatments for non-motor symptoms typically only address a single symptom. As a result, people with Parkinson’s must take many medications to address these non-motor symptoms.
Click to learn more
Clinical trials are important for developing new treatments or advancing existing treatments for medical conditions such as Parkinson’s. However, clinical trials can only take place and potentially help advance treatments for Parkinson’s if people like you volunteer to participate.
By participating in Parkinson’s clinical trials such as STEM-PD, you can play a more active role in your health care, possibly have access to an investigational new treatment before it is widely available, and ultimately help others with Parkinson’s by contributing to medical research.
Click to learn more
Clinical trials are reviewed and monitored by an ethics committee. These committees are made up of doctors, researchers, and members of the community. Its role is to make sure that the study is ethical and that the rights and welfare of participants are protected, including making sure that research risks are minimized.1
Participation in clinical trials is completely voluntary. Only those who want to participate will be included, and an informed consent document discussing the study requirements, risks and benefits, and data collected will be reviewed. This document is signed prior to any study activities starting.
In the STEM-PD Clinical Trial, the investigational treatment will be given to a large group of people to evaluate its safety and effectiveness as a treatment for symptoms in Parkinson’s.
If the results show that people do benefit from this treatment, then the U.S. Food and Drug Administration (FDA) would consider authorizing this new Parkinson’s treatment to be offered to more people.
Until now, Parkinson’s disease treatments mainly focused on helping motor symptoms or specific non-motor symptoms of Parkinson’s. The STEM-PD clinical trial is testing the ability of a non-invasive investigational medical device to help improve many non-motor symptoms as well as motor symptoms in Parkinson’s.
The purpose of the STEM-PD clinical trial is to understand how a non-invasive, home-use, neuromodulation investigational device affects adults diagnosed with Parkinson’s. A non-invasive device stays outside of the body, and neuromodulation means that the device stimulates activity in the brain.
The STEM-PD clinical trial does not require surgery and does not include investigational medicines.
You may be a good candidate to participate in the STEM-PD trial if you:
*A participating site will ask you more questions to determine if you might be eligible.
If you agree to take part in the STEM-PD trial and are eligible, your participation will last about one year and will include in-person visits, virtual visits as well as phone calls. Additionally, you will answer questions using a smartphone.
In this study, participants give themselves the treatments with the investigational device, which looks like a set of music headphones, at home twice a day, 20 minutes at a time. Each study treatment delivers a stimulation pattern.
During the first four months, you will be in the randomized clinical trial phase. You will be randomly assigned (like the flip of a coin) to one of two study treatment groups. The two groups will use the same device but will receive different stimulation patterns. You or your doctors will not know which group you are in.
In the second phase during the remaining eight months, everyone will receive a device programmed with the neurostimulation pattern reported to show benefit in a previous Parkinson’s clinical trial. This second phase includes two treatment periods and follow-up after you stop treatment with the investigational device.
To take part in this clinical study you will need to:
Your study partner will need to: