Table 2.

Patient-Centric Regulatory Considerations

Final Attributes with Descriptions
Benefits	Amount of time your Parkinson’s treatment works each day Relevant to all treatment types Parkinson’s symptoms can include movement symptoms (such as tremor, slowness of movement, unsteadiness, and rigidity) and nonmovement symptoms (such as sleep problems, low blood pressure when standing up, trouble thinking clearly, and mood problems). People with Parkinson’s disease can experience the following situations during the day: • Your Parkinson’s treatment is working and the Parkinson’s symptoms are controlled better. The time each day when the Parkinson’s treatment is working to control your symptoms is called “on time.” • Your Parkinson’s treatment is not working and the Parkinson’s symptoms get worse. The time each day when the Parkinson’s treatment is not working and your symptoms are worse is called “off time.”
	Movement symptoms of Parkinson’s disease Relevant to all treatment types People with Parkinson’s disease experience different types of movement symptoms. These symptoms can include • Resting tremor: A trembling in a body part when that body part is not performing an action • Postural instability: Being unsteady or lacking balance when standing upright • Bradykinesia: Slowness of movement and limited range of movement • Rigidity: Unusual stiffness in one more arms, legs, or in another body part Not all people experience the same movement symptoms.
	Pain because of Parkinson’s disease Relevant to all treatment types Some people with Parkinson’s disease experience pain. This pain can include aching or burning muscle pain and severe muscle cramping, sharp nerve pain, numbness, or “pins and needles.”
	Trouble thinking clearly, getting organized, or making plans because of Parkinson’s disease Relevant to all treatment types Some people with Parkinson’s say that the disease affects their ability to think clearly, get or stay organized, or make plans. When this happens, people sometimes need to make lists to help them organize their thoughts. If you have difficulty thinking clearly, it may be hard for you to remember things that you used to be able to remember easily. Sometimes planning your usual daily activities is harder than it used to be.
Risks	Increased risk of depression or anxiety Relevant to all treatment types Sometimes people with Parkinson’s can experience emotional problems such as depression and anxiety because of their disease. In addition, some devices used to treat Parkinson’s disease can affect people’s mood and cause depression and anxiety. Depression is a serious medical condition that affects the way you feel, think, and how you act. People with depression may lose interest or pleasure in doing things they once enjoyed. They may feel sad and hopeless or have feelings of guilt or low self-worth. Depression can affect how you work and study and how you interact with people. It may lead some people think about suicide. Anxiety is the feeling of being constantly overwhelmed or afraid. Anxiety can impact your ability to do your usual daily activities. The risk of depression or anxiety related to the Parkinson’s device is in addition to the chance of depression or anxiety you may already face because of Parkinson’s disease.
	Risk of a bleeding in your brain because of the device Relevant to medical devices There is a risk that you could have bleeding in the brain after getting a device to treat Parkinson’s disease. Bleeding in the brain is a type of stroke and occurs when a blood vessel in the brain bursts. Blood in the brain can kill brain cells and cause permanent damage to the brain. The damage to the brain can cause you to experience sudden weakness, loss of coordination, or difficulty speaking. A severe stroke can lead to permanent paralysis. If you have a stroke caused by bleeding in your brain, you would have to be treated in a hospital, sometimes for many weeks. You cannot do your normal activities while you have brain bleeding.
	Risk of dying within 1 year after getting a device Relevant to medical devices There is a risk that you could die within 1 year after getting a device to treat Parkinson’s disease. Dying could be a result of the operation used to place the device in your brain or a result of the device itself.
Other considerations	Time until the device is available Relevant to medical devices Some devices that could be used to treat Parkinson’s disease are currently being developed and tested and may not be available to patients yet. The process of developing and testing new device treatments can take years. Sometimes patients are willing to wait to get a new device to treat their disease if the benefits of the device are expected to be better than the treatments that are available to them now.
	Number of oral medicines you take each day to treat Parkinson’s disease and the side effects of Parkinson’s medicines Relevant to medicines People with Parkinson’s often need to take a lot of pills or tablets each day to treat the disease. In addition, people with Parkinson’s may need to take additional medicines to treat the side effects of their Parkinson’s medicines. Usually, people need to take oral medicines throughout the day. Often, people need to take these medicines on a very specific schedule in order for the treatment to work well.