More Information on Clinical Trials

A clinical trial (also clinical research) is a research study in human volunteers to answer specific health questions. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people and ways to improve health. Interventional trials determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments. Observational trials address health issues in large groups of people or populations in natural settings. You can find out more information about clinical trials at the federal government’s website, Clinical Trials.gov

Every member of CINRG is required to take a human subjects review course that teaches about the ethics of research with human patients. This is to be in compliance with both the Department of Health and Human Services and Institutional Review Boards (IRB). Both organizations make sure that CINRG is doing its job at protecting patients.

During your first visit to the clinic, you/your child will be evaluated by members of the research team, including the study doctor, physical therapist, the research nurse and study coordinator. This initial visit is often lengthy and may involve an overnight stay with a two day visit to the research clinic. The study coordinator can direct you to local lodging available during all of your research study visits. The research study/studies that you/your child are eligible for will be explained to you/your child in detail. If you decide you are interested, you will sign the informed consent before any study tests are performed. If your child is enrolling in the study, and over the age of 7, he will sign an assent, also. You will be given a copy of this form to reference throughout the study.

After you have signed the informed consent, you/your child will perform several tests to ensure you/your child meets entry criteria for the study. The study doctor will explain all of these procedures to you. These tests may include (but aren’t limited to):

• Strength testing:
• Manual muscle testing - The physical therapist will ask you to push and pull on his/her hands to measure your strength
• Quantitative muscle testing - You will sit or lie on a table and you will be asked to push and pull against a strap to measure your strength
• Functional tests: These are the usual items performed when you/your child visits the neurologist. For example, walking across the room and standing up from the floor.
• Lung function test: You will be asked to breathe into a plastic piece to measure the strength of your lungs.
• The study doctors will then examine you during a physical exam, review you/your child’s medical history (including any illnesses, surgeries, etc) and review any medications, herbal supplements and vitamins you/your child is taking.
• A small amount of blood will be collected at some visits using a needle.
• Depending on the research study, other procedures may be required such as a DEXA, MRI or ECG.

Research study visits are different than your usual clinic visit. Please feel free to contact us to answer any questions you may have.