San Diego State University Research Opportunity:
For this study, we will invite two groups of people: 1) people with PD, and 2) age- and gender matched neurologically healthy individuals (controls).
We will ask our participants to wear an acti-watch for one week. This watch looks like a digital watch and you can wear it all day.
Using this watch, we will measure the quality of participants' sleep for one week.
Then, we will ask each participant to come to our lab, Neural Control of Human Locomotion Laboratory, and to participate in our gait study.
For this study, the subject should be able to "walk" on a treadmill for about 30 minutes (with lots of rest breaks) twice, morning and afternoon, in one day.
So, the participants should join us from 8:30am to 3:30pm (or 4:00pm) for only one day.
PD patients who have the following characteristics can not participate in this study:
if they have another significant neurological disorder (stroke, etc), implanted deep brain stimulation (DBS) or other neurosurgeries to treat PD, history of freezing of gait (FOG) episodes, evidence of cognitive impairment (Mini Mental Status Examination, MMSE, score of < 26), severe concurrent medical problems (e.g., severe cardiac disease, history of poorly controlled brittle diabetes, active cancer), hearing or cutaneous sensation of the feet, any musculoskeletal disorder in legs, chronic low back pain, or hip or knee replacement.
To see an abstract description of the study, click here.
Should You Volunteer In Parkinson’s Research Studies?
If you have Parkinson’s, you may be asked to volunteer for a research study. Deciding whether or not to sign up is an important decision. Learning about research studies can help you decide if being a volunteer is right for you.
What is a research study?
Research studies are done when doctors and scientists want to find new ways of treating an illness. Research studies are often called clinical trials. Most Parkinson’s studies focus on new medicines. Others focus on treatments such as surgery.
Why are research studies important?
Research studies are important because they help discover new treatments. They are done to make sure that new medicines are safe and that they work. Research studies couldn’t be done without volunteers. People who volunteer for research studies make new treatments possible.
Why should I sign up for a research study?
There are some good reasons to sign up for a research study:
You may be able to get new treatments before they are available to the public.
You will receive expert health care, usually at no charge.
You are helping to find new treatments, which will help others who get Parkinson’s.
What questions should I ask?
Before you decide to sign up, you should learn as much as you can about the research study. You should feel comfortable with the research team so that you can ask questions. Asking these questions will help you learn more about the study.
1.) Does the study test a new drug or piece of equipment?
2.) Do I have a chance of getting a pill that isn’t the study drug?
3.) Why is the study being done?
4.) How long will the study last?
5.) Where will I have to go for study visits?
6.) How many visits will I need to make?
7.) What tests and treatments will I take part in?
8.) Who will be in charge of my care?
9.) Are there other treatments that might help?
10.) What are the risks?
11.) What are the benefits?
12.) Who is paying for study treatments?
13.) What are my rights as a volunteer?
14.) Will my study information be shared with others?
15.) Will I have to pay for treatment?
What are the risks?
There are also risks when you sign up for a research study. Some medical tests or side effects may be uncomfortable, and the treatment may not help your Parkinson’s. Being a volunteer in a research study can take extra time. For example, you may need to make extra trips to the study office.
What happens if I decide to volunteer?
If you decide to volunteer, you must sign an informed consent form. The form includes answers to all of the questions above. It also lists details such as important phone numbers. You should read the form closely and ask any questions that have not been answered. Once you sign the form, you will be given a copy of it. Then you can begin to take part in the study. Even though you have signed the consent form, you can decide to stop being in the study at any time.
Only you can decide whether or not to be in a research study.
You can choose to stop being in the study at any time.
Volunteers make new treatments possible.
Key terms to know:
As you learn about research studies, you may come across words that are not familiar to you. Here is a short list of research study terms and what they mean.
IRB (Institutional Review Board): The IRB is a group of doctors, health care professionals, and members of the community. The IRB reviews the study plan and informed consent from to make sure that the safety and rights of the volunteers are protected. Every research study must be approved by an IRB.
FDA (Food and Drug Administration): The FDA is the government office that makes sure that all drugs and medical devices are safe and helpful.
Protocol: The protocol is the study plan. The protocol describes what types of people can volunteer, how long the study will last, and what will take place during the research study. The protocol is designed to protect the volunteers’ safety throughout the study.
Placebo: A placebo is a pill that doesn’t have any medicine in it. It looks like a drug, but causes no changes in the body. Some research studies will compare the new treatment with a placebo.
Phase of Study: All drugs and treatments go through different phases of research before they are approved. Most studies that you may sign up for will be Phase 2 or Phase 3 studies.
Phase 1 Study: Phase 1 studies are usually done with healthy volunteers. The new treatment is tested in a small group of 20-80 people to look for side effects and judge safety.
Phase 2 Study: Phase 2 studies are done with a larger group of people who have the target illness, such as Parkinson’s. The goal of Phase 2 research is to test how well the new treatment works, and to gather more information about side effects and safety.
Phase 3 Study: Phase 3 studies are done with a larger group of at least 500 people. Phase 3 testing compares the new treatment with similar treatments that are already approved.
Study Design: There are several different designs, or methods, for research studies. Here are three common designs:
Placebo-controlled studies are those in which some people will get a pill without any medicine in it.
Single-blind, placebo-controlled studies are those in which either the study patient or the researcher does not know if the patient is receiving the actual study drug or a placebo.
Double-blind, placebo-controlled studies are those in which neither the study patient nor the researcher knows if the patient is getting the study drug or a placebo. Double-blind studies are thought to be the best study design.
Want to know more?
For more information, please call the Parkinson’s Association of San Diego at 858-273-6763, toll-free at 877-737-7576, or email email@example.com.