Category Archives: Medical Research

Clinical Trials and Cerebral Palsy: The Basics

Clinical Trials and Cerebral Palsy
Parents of children with cerebral palsy spend incredible amounts of time and energy searching for the latest therapies and advancements in medicine that will benefit their child, but how much do you know about the research process that occurs in bringing therapies and medicines to market?

There are hundreds of clinical trials being conducted in Universities and Hospital around the world in a quest to find medications, therapies and surgical interventions that will improve the quality of life of children and adults with Cerebral Palsy. It’s with increased frequency that we encounter breaking news stories of the positive impact new medical discoveries are having on the lives of children with CP. Many of these life changing interventions started with Clinic Trials.

Here are some of the basics you need to know.

What is a Clinical Trial?

Clinical trials are research studies that explore whether a medical treatment, or device is safe and effective for humans. These studies also may show which medical approaches work best for certain illnesses or groups of people. Clinical trials produce the best data available for health care decision making. Clinical trials are conducted at medical centers, hospitals, universities and private facilities all over the world. The investigator in charge of the study must ensure that all clinical administrators, no matter where they are, are conducting the trial(s) in exactly the same manner.

All FDA approved clinical trials are conducted in 4 phases and can last for many years.

  • Phase I: Screening for safety. A small number of patients and healthy volunteers (20-80) test a drug/procedure for safety, tolerance, dosage range and side effects.
  • Phase II: Screening for effectiveness. Also involving a small number of patients (100-300) to determine the short and long-term effect on a patient’s cerebral palsy.
  • Phase III: Comparative results. To determine how new treatments compare to the standard treatments already in place. These trials may be conducted on hundreds or thousands of patients on a much larger scale, sometimes even nation-wide.
  • Phase IV: Postmarketing studies. To further delineate risks, benefits and optimal use.

Why Are Clinical Trials Important?

Clinical trials are a key research tool for advancing medical knowledge and patient care. Clinical research is done only if when doctors don’t know how to treat a disease or condition.

Who Can Participate in Clinical Trials?

Each clinical trial defines who is eligible to take part in the study. Each trial must include only people who fit the patient traits for that study (the eligibility criteria). For more information about eligibility criteria, go to “How Do Clinical Trials Work?” Some trials enroll people who have a specific disease or condition. Others enroll healthy people to test new approaches to prevention, diagnosis, or screening.

Children and Clinical Trials

Pediatric clinical research networks (PCRNs) have been existence for over five decades with pediatric oncology community establishing the first networks in the 1950s.[38] Now networks exist across continuum of care (primary, secondary and tertiary care), across specialties (oncology, nephrology, neurology, etc) and across several countries.

Should Your Child Participate in a Clinical Study?

Parents and caregivers have many questions when considering enrolling a child in a clinical study and many times children and adolescents also want to know what they will go through. The NIH provides helpful resources that provide information on why clinical studies are important, how children might benefit from participation, and what you should think about before, during, and after joining a study.

To help with a child’s understanding, the New England Research Institutes (NERI) has introduced a web site called The Kids Files, designed for kids and parents to explore together and learn about clinical studies, through interactive games and activity pages. Another helpful tool is a newly launched video game called “The Paper Kingdom,” The game is aimed at kids ages 8 -14 and helps dispel myths and misconceptions about medical clinical trials. The game was officially launched this week on the website of the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health. It is available as a free download from the Children and Clinical Studies website and is rated “E” for everyone.

In part 2 of this article, we address what current Clinical Trials are addressing CP and Where to Find Clinical Trials in your Area

 

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How Do I Find Out About Clinical Trials in My Area?

Finding Clinical Trials
In a previous blog, we covered what clinical trials are, the 4 FDA-mandated phases of a trial, the benefits and risks of participating, what current clinical trials relate to cerebral palsy and what might be involved in qualifying for one. The next step is learning how to find clinical trials in your area.

At some point it will go without saying, but the internet is your best source for finding clinical trials being conducted in your area. I took several sites for a test run and here’s what I found:

Clinicaltrials.gov

In February 2000, the federal government, through the US National Institutes of Health (NIH), launched a searchable database at clinicaltrials.gov. As of this writing, the site claimed to have details on 397 clinical trials that related to cerebral palsy (many were already labeled “complete”). The top one listed was being conducted by the University of British Columbia and involved researching pre-op and post-op “quality of life” in 24 CP patients, ages 4-18, who were undergoing a specific type of hip surgery at BC Children’s Hospital in Vancouver.

I then narrowed my search to “cerebral palsy Texas.” From 397 down to 22… 11 completed, 1 terminated, 1 not yet recruiting, 1 by invitation only. Still, I got the results I’d asked for.

The amount of information found on the link for each trial is impressive and very detailed, including a list of both inclusion and exclusion criteria for each trial.

According to their FAQ section, all funded and unfunded studies in the US must be registered with the FDA, which would imply that this database is 100% exhaustive.

Center Watch

Centerwatch.com was the first non-government site to publish detailed information about active clinical trials. They boast one of the largest databases of clinical trials representing more than 650 medical conditions in 58 countries. I randomly clicked on a Phase III trial, sponsored by Ipsen (a French pharmaceutical company) for Dysport® (a botulinum toxin A) that was simultaneously being conducted at numerous facilities throughout the US. “The purpose of this research study is to determine whether repeat treatments with Dysport® are safe and effective in the treatment of increased stiffness of the calf muscles and whether Dysport® can lessen the pain caused by spasticity and improve the child’s wellbeing.” Through Centerwatch, I also found studies on Botox injections (also a botulinum toxin), a study on scoliosis and one for an unnamed ankle strength training device.

There were far fewer listings on centerwatch and the links to the studies themselves revealed less details when compared to clinicaltrials.gov (such as no inclusion or exclusion criteria). Still, a lot of good information. My feeling is that this website is great for finding clinical trials taking place outside US borders.

National Health Service

That’s right. England’s National Health Service (NHS). At first, this appeared to be one of the better databases. Despite being in England, they listed a wide cross-section of clinical trials being conducted in the United States, including 84 relating to cerebral palsy, with titles such as “Orthotics in Ambulatory Cerebral Palsy,” “Surface EMG Biofeedback for Children with Cerebral Palsy,” and “Acupuncture as Complementary Therapy for Cerebral Palsy.” There were some that I’d seen elsewhere, but many I had not.

I randomly chose “Relaxation Training to Decrease Pain and Improve Function in Adolescents with Cerebral Palsy.” The study link took me to a thorough detailing of the study… key inclusion and exclusion criteria, target sample size and contact information. The only thing I didn’t see was exactly where this trial was taking place, but there was a “link to the clinical trial website.” When I clicked it, it took me to a listing, with the exact same information, on the World Health Organization’s International Clinical Trials Registry Platform, who, in turn had a link back to the clinicaltrials.gov website.

World Health Organization

The World Health Organization’s website has a much more sophisticated “advanced search” section than I’d previously encountered. I kept it simple and just put in “cerebral palsy,” “united states” and “recruiting” in the appropriate field boxes. Unfortunately, the first study I clicked on, “Study of Vibration therapy and Hand functions in Cerebral Palsy Patients” led me to a study in India. I double checked that I’d entered “United States” and tried again. I chose a study called “Cohort of Children with Severe Cerebral Palsy” (because I had no idea what that even meant!). It took me to a study in Lyon, France. A third try took me to one in Belgium.

So, clearly the search section of this website doesn’t function as it should. Plus, it appears that on this site, as well as the NHS one listed above, all the listings for actual US clinical trials are lifted directly from the clinicaltrials.gov website. There could be exceptions, but I didn’t find any.

Other Sites

The CPI (Cerebral Palsy International Research Foundation) does not host a database of ongoing trials, but frequently provides news items regarding innovations and upcoming trials. Good place to keep checking.

Science2.0 and SingularityHUB  are blogging sites that sometimes announce new clinical trials.

Trialsfinder.org aggressively required me to fill out a questionnaire regarding my own health before I could gain access to their site. I declined. Search Clinical Trials.org requested similar information.

Entities such as Future Search Trials (Dallas and Austin) and Boston Children’s Hospital are examples of regional sources, although neither currently have trials related to CP.

My suggestion is to search “clinical trials cerebral palsy (your city) year.” I’d include the current year to avoid outdated information–once on the internet, forever on the internet.

Other Methods

In addition to monitoring websites, contact area hospitals and universities to find out how they go about announcing upcoming clinical trials and see if you can get on a notification list. The people conducting clinical trials are spending large amounts of money to garner the most useable information possible. You can trust that they want to attract the most qualified candidates in the area and will make their presence known.

Of equal importance, stay keyed into local and regional support groups. Make sure others in your area are aware of your desires to be informed if they hear of something before you do.

Your child’s doctors and therapists may also be able to help you find and get approved for local clinical trials.

However you chose to look for clinical trials, keep a detailed and organized record of your results so that you don’t spin your wheels and end up back at the same place over and over.

 

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Broccoli Sprouts May Prevent Cerebral Palsy, Research Suggests

By Katelyn Verstraten, Special To The Vancouver Sun

The answer to preventing one of the main causes of cerebral palsy may be as simple as eating broccoli sprouts during pregnancy.

Dr. Jerome Yager, a pediatric neurologist and research scientist from the University of Alberta, is working with animal models to determine if antioxidant-rich broccoli sprouts can protect the developing brain of a fetus during pregnancy.

Female rats that ingested raw broccoli sprouts during pregnancy had fetuses with significantly more resilient brains than rats that were not fed broccoli sprouts.

If the sprouts were consumed before an injury to the fetal brain, between 60 to 80 per cent of the injury was prevented. If the sprouts were consumed after the brain injury, this dropped to 40 per cent.

Cerebral palsy occurs when a developing brain is damaged during pregnancy, delivery, or in the first several years of a child’s life.

Around 80 per cent of these brain injuries occur before birth, Yager says. This has many families searching for more preventive measures.

Cerebral palsy is the most common cause of both physical and developmental disability in children, and affects one in 500 British Columbians. Lifelong costs are around $1.5 million per individual. Despite advances in western health care, this prevalence has not decreased.

Broccoli sprouts initially generated attention for their potential to prevent certain cancers. Recent studies have demonstrated their ability to decrease inflammation from injuries and stimulate brain resilience.

“(The antioxidant) binds to a certain chemical in the brain, which actually increases the brain’s ability to fight off oxidants,” said Yager. “It kind of ‘revs up’ your own system – it’s quite cool.” While the study has only looked at animal models, he admits that results so far have been impressive. The next step is beginning clinical trials in humans.

Yager recently ran a focus group of pregnant women to determine if they would actually eat the broccoli sprouts. The majority of women reported they would incorporate the sprouts into their diet – if it were to benefit the fetus. But could the answer to preventing fetal brain damage really be an underdeveloped broccoli plant?

“Often times the simple things are the best,” said Yager. “They are often not taken as seriously as they should be – but they often are the best.”

This article was produced under a summer internship funded by MITACS, a Canadian research organization that co-ordinates industry-university research collaborations, and NeuroDevNet, a Canadian Network of Centres of Excellence focused on children’s brain development. The National Core for Neuroethics at the University of British Columbia, in partnership with NeuroDevNet, supervises the intern’s research.

Read original article.

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