Neuroscience Clinical Research

Informed consent is the process of learning about a study before you agree to join. A team member will review a written consent form with you that explains the study's purpose, procedures, risks, possible benefits, and your rights. Take your time, ask questions, and talk it over with family or your doctor. You only sign when you're ready.

 Every study is different, some are longer than others. Sometimes it is a combination of in person visits and phone visits, but other times it is only one or the other. The study protocol for each study outlines this information. It will be listed in your informed consent form that you will have a copy of for your records.

We will review these ahead of time, and they will also be listed in the Informed Consent Form. You are welcome to review this document ahead of time before committing to a Screening Visit, and either the coordinator and/or the physician are available to discuss and answer questions about these. There are some common side effects you may experience depending on the specific trial. It is ultimately your decision (and if you want to consult your primary care physician, he/she can maybe help you decide if the benefits of participating outweigh the risks.)

If you experience side effects, it is important to report them to the study coordinator right away. We will follow the guidelines regarding reporting these to the sponsor. If the side effects occur after hours, we have a 24-hour phone number you may call to report these. You will be treated and advised on what to do if this occurs. If it is during regular business hours, it is best to call the study coordinator you have been working with on her direct line.

It's a research study that tests whether a treatment safely reduces pain and/or improves quality of life. That treatment  might be a new medication, a new form of an existing medication, a device, an injection, or a non-drug approach. Every study follows a detailed plan, called a protocol, that has been reviewed for safety and ethics before anyone enrolls.

Every pain medication available today was once tested in a clinical trial. Researchers are especially focused on finding effective options that carry less risk of side effects or dependence than some current treatments. Volunteers make that progress possible. Clinical trials are how new pain treatments are tested and proven.

Each study has its own requirements, called inclusion and exclusion criteria. These usually cover your age, the type of pain you have, how long you've had it, how severe it is, and your general health. The criteria protect your safety and help make the study's results reliable.

Start by calling us or filling out our online interest form. A team member will ask some questions about your pain and health history. If a study looks like a good fit, we'll invite you for a screening visit, which may include a physical exam, lab work, and a review of your medical records.

Not qualifying for one study doesn't rule you out of others. With your permission, we can keep your information on file and reach out when a better match opens.

Our studies change over time, but pain trials often focus on conditions such as:

• Chronic low back pain
• Osteoarthritis of the knee or hip
• Diabetic nerve pain (peripheral neuropathy)
• Other types of nerve pain
• Migraine and other headache disorders
• Pain after a procedure or minor surgery
• Neck pain
• Abdominal pain

If your condition isn't listed, contact us anyway. New studies open regularly. A trial studying a condition you are inquiring about may be starting at our site soon, or we are happy to research other available trials to potentially bring to our center.

Many of our studies do not require insurance. Our team will tell you during screening whether a specific study does.

Study-related visits, exams, tests, and study medication are typically provided at no cost to you. It depends on the study and what phase it is in. Many studies also offer compensation for your time and travel. The exact amount is listed in the consent form for each study.

It varies. Some pain studies last a few weeks, while others continue for several months or longer. You'll know the full schedule, including the number of visits, before you agree to join.

It depends on the study. Some studies allow your usual medications. Others ask you to stop or adjust certain ones for a period of time, called a washout. Never change your medications on your own. Our study doctors will walk you through exactly what is allowed and help you do it safely.

Usually, yes. Many pain studies ask you to rate your pain each day in a diary, often on a smartphone app or a device we provide. These daily ratings are some of the most important information in a pain study, so we'll show you how to use the diary and help if you have trouble. Sometimes you will just report on your pain and/or quality of life since the previous visit on questionnaires at each visit.

You might, it depends on the study plan. Many pain studies compare the study treatment with a placebo, which looks like the real treatment but contains no active ingredient. Comparing the two is the most reliable way to know whether a treatment truly works. It is important to listen to all the details of the study plan. Sometimes, if you do get randomly assigned the placebo group, there is a timepoint later in the study, where you can cross-over into the study treatment arm. You'll be told before you join whether or not the study uses a placebo and what your chances are of receiving it.

Tell the study team right away. Many pain studies allow a "rescue medication," a specific pain reliever you can take if your pain becomes hard to manage. The study doctor will explain which rescue medications are allowed and how to use them. Your comfort and safety always come first. If the trial is studying a procedure, you may be able to have a different procedure if you are not experiencing pain relief following it. It is important to discuss this situation with your study team before taking a different medication or scheduling another procedure to make sure it is done according to the study plan.

Yes. Participation is always voluntary, and you can leave at any time for any reason. Leaving won't affect your regular medical care. We may ask you to come in for a final safety visit.

Your information is kept confidential and protected under federal privacy laws. Study data is labeled with a code instead of your name. Only authorized people, such as the study team, the sponsor, and regulators, may review your records, and only to make sure the study is run correctly.