Adapted from the Brain Injury Association of America article. Many thanks to the Brain Injury Association of America I & R Dept for their assistance in researching this issue.
A common question people with brain injury and their families ask is: "Where can I find information on clinical trials for brain injury?" There is not just one answer to this question. Unlike specific diseases, such as AIDS and cancer, there is not a single location where the majority of brain injury clinical trials are listed. A possible reason for this is the nature of brain injury and the level of public awareness. Brain injury is not "one disease." There are distinct stages that occur during the recovery process. For instance, during the acute stage, pharmacological (medication) interventions are geared towards minimizing additional adverse medical consequences. During the post acute stage, persons are medically stable, but may have cognitive, physical, or emotional impairments. Locating clinical trials on brain injury can be challenging. The following information offers suggestions for searching for clinical trials and a listing of a sample of clinical trials currently recruiting volunteers. Considerations when searching for clinical trials:
There are no guarantees. You may search the clinical trial databases-- and find nothing. There is no guarantee that there is something out there that will help your particular situation. However, you may find that these sites can point you in the right direction.
The presence of a clinical trial does not automatically mean you will qualify to participate, receive the treatment being offered, benefit from the treatment being offered, or "be cured" of brain injury. Keep in mind, this is research, and at the present time there is no cure for brain injury. Researchers set up a study because they have reason to believe, but are not sure about, an intervention and need more information.
Discuss the information with your doctor before participating. Research trials are designed to be as risk free as possible, but by their very nature, research trials are looking into the unknown. Take the time to read through ALL research material, and ask questions. A good resource to read is a guide developed by the National Institutes of Health. You can go here to read this guide: Volunteer Patients and Clinical Research. This Guide describes the basics of clinical research, what the different "phases" mean in clinical trials, and questions you may want to ask before choosing to participate in a research study. Consider the potential benefits and potential drawbacks of participating in a clinical study. Discuss the information you find with your doctor.
Participation in clinical trials is a personal choice and may not be for everyone. Choosing to participate or not to participate is an individual decision that should be respected.
There are several resources worth reading that cover the basics of research trials. These include:
Guide to Clinical Research This brochure was developed by the Warren Grant Magnason Clinical Center. This Center is where the National Institutes of Health conduct much of their clinical research. The brochure describes the basics of clinical research, what the different "phases" mean in clinical trials, and questions you may want to ask before choosing to participate in a research study.
Search for local universities or large rehab centers. These are places that might be running clinical trials. Sites listed below will help you identify some of the major research centers associated with Universities.
Some websites offer personal clinical trials notification, and will email updates on trials relevant to a person's interest.
Some websites require user registration prior to a site search. Most sites only require you to register with an e-mail address.
Some websites may ask for your mailing address, name, area of interest, etc. before they allow you to gather research trial information. Make sure you read their privacy policy before doing so.
The list of clinical trials provided below is not comprehensive- it is intended to be a helpful resource for persons starting to look for clinical trials.
ACURIANwww.acurian.com This website features the capability to develop a personal profile of information. Registration is not required to search the database.
CenterWatchwww.centerwatch.com CenterWatch offers a listing of clinical trials and a personal clinical trial notification option.
PhRMA.orgwww.phrma.org The Pharmaceutical Research and Manufacturers of America represents research-based pharmaceutical and biotechnology companies. The site does not offer a specific listing of clinical trials, but provides information about prescription medication in development, and available from member companies. They have a second website: www.helpingpatients.org that lists patient assistance programs available through PhRMA's 48 member companies. These programs can assist people in obtaining prescription medication at free or reduced costs.
TrialsCentralwww.trialscentral.org This site offers a listing of clinical trials, as well as a resource section that offers educational materials.
Veritas Medicinewww.veritasmedicine.com This is a searchable site of clinical trials and treatments. A personal clinical trial notification option informs a registered user of possible opportunities to participate.
The Warren Grant Magnuson Clinical Centerwww.cc.nih.gov 800-411-1222 or 1-866-411-1010 (toll free TTY). The Warren Grant Magnuson Clinical Center has listings for National Institutes of Health (NIH) funded studies. This site is where many NIH research studies are carried out.
Current Research Trials of Interest:
Neure uses several sites to identify clinical trials that may be of interest to professionals or people looking to volunteer for clinical trials. They include:
Study testing an investigational medication for memory loss. Radiant research is based in Las Vegas, NV.
Craig Center for Spinal Cord Injury Research Craig Hospital specializes in brain and spinal cord injury rehabilitation. Their Center for Spinal Cord Research coordinates clinical trials of promising treatment for spinal cord injury. Visit their website to learn what clinical trials are ongoing at Craig.
Craig Hospital Brain Injury Research. Craig Hospital specializes in brain and spinal cord injury rehabilitation. Their Brain Injury Research investigates promising treatment for brain injury. Visit their website to learn what clinical trials are ongoing at Craig.
Prospective Memory in Children with Traumatic Brain Injury Prospective memory (PM) is memory to complete future tasks, such as recalling to give a note to someone when you next see them, pick up milk on the way home, or remembering to keep an appointment. This study will evaluate PM in children with traumatic brain injury (TBI).
Home Stimulation for Brain-Asphyxiated Infants This study examines the potential benefits of a home stimulation program to treat infants who have suffered from brain asphyxiation (lack of oxygen). The program involves one year of stimulatory activities. Progress will be evaluated through neurological and behavioral exams.
I. Determine the relationship of closed head injury (CHI) severity, focal brain lesions, and the age at injury to the development of working memory, inhibition, and metacognitive skills in children or adolescents with CHI of varying severity.
II. Assess the development of working memory, inhibition, and metacognitive skills in relation to discourse functions, scholastic achievement, and adaptive behavior in these patients.
III. Determine the relationship between impaired inhibition, metacognitive skills, and the emergence of psychiatric disorder in these patients.
