Washington University School of Medicine is conducting a research study to determine safe and effective dosing for Oral Baclofen for children with Cerebral Palsy. This research study is being sponsored by the National Institute of Child Health and Human Development (NICHD), an agency of the federal government.

Oral Baclofen is a medication that has been used for decades to treat spasticity (muscle stiffness) in adults and children with Cerebral Palsy. However, there is currently little information about how effective Oral Baclofen is for treating spasticity in children.

Washington University School of Medicine and St. Louis Children’s Hospital are partnering with ten other sites (hospitals and universities) across the United States to conduct a study to determine the effectiveness of a liquid form of Oral Baclofen in children with Cerebral Palsy. This study will provide information regarding starting dosages, maximum dosages and rate of dosage administration. Thus providing physicians nationwide with evidence that is needed to ensure children are prescribed the safest dosage while also receiving the most beneficial effects from the medication.

To enroll, your child must have a diagnosis of Cerebral Palsy and be between the ages of 2 and 16. In addition, he or she must not have received Oral Baclofen (or Intrathecal Baclofen) 4 months prior to the start of the study. The study will require a minimum of three visits with a maximum of six visits. An overnight visit at the Pediatric Research Unit at the local Children’s Hospital may also be required for the child. Participation benefits include, but may not be limited to, medication, physical examination and diagnostic testing at no cost.

If you would like any further information or if you wish to be considered for this study, please visit this site or contact one of the sites listed below.

Washington University School of Medicine
St. Louis Children’s Hospital
St. Louis, MO
Principal Investigator: Jan Brunstrom-Hernandez, MD
Contact: Shellie Lackey
Phone: 314-454-6120
Email: lackeys@neuro.wustl.edu

Rehabilitation Institute of Chicago
Chicago, IL
Principal Investigator: Deb Gaebler-Spira, MD
Contact: Maxine M. Kuroda, PhD, MPH
Phone: 312-238-2846
Email: mkuroda@ric.org

Gillette Children’s Specialty Healthcare
St. Paul, MN
Principal Investigator: Linda Krach, MD
Phone: 651-229-3873 or 612-626-5578

University of Minnesota
Minneapolis, MN
Contact: Jennifer Engen, RN
Phone: 612-626-1421

Kluge Children’s Rehabilitation Center and Research Institute
Charlottesville, VA
Principal Investigator: Richard Stevenson, MD
Contact: Stephanie Lowenhaupt, RN, CCRC
Phone: 434-982-6421
Email: sal3q@virgina.edu

Cincinnati Children’s Hospital Medical Center
Cincinnati, OH
Principal Investigator: Jilda Vargus-Adams, MD
Contact: Lauren Kennington
Phone: 513-636-7506
Email: lauren.kennington@cchmc.org

Seattle Children’s Hospital
Seattle, WA
Principal Investigator: John McLaughlin, MD
Contact: Seattle Children’s Developmental Medicine Research
Phone: 206-884-2756

NEW 3/10: Children with Cerebral Palsy Needed For Study on Leg Motor Coordination – NIH

The purpose of this research study is to compare how children with cerebral palsy or CP move their legs compared to children who do not have CP. We will also study if how children with CP move affects how their muscles and brains look. Finally, we will study if fast exercise improves motor and brain function. The ultimate goal is to design training programs to help children with CP move better.  

This CP Coordination Protocol (T-CC-XXXX) is a non-invasive outpatient study that will require up to 3 visits to the NIH in Bethesda, MD (6 visits if you choose to do each of the two parts on different days). Each visit has two parts. The first part takes 3-4 hours and is testing to see how you move your legs when walking and using different pieces of exercise equipment. We will also test your strength and take pictures of your leg muscles.. The second part is a brain scan. that will take @ 1 hour. You do not need to do the brain scan to be in the study. 

The study also involves an optional exercise program. If you choose to do the exercise program, you will do a 3-month training program with either a stationary cycle or an elliptical trainer that will be loaned to you for use at home.  

We are currently seeking child and adolescent volunteers with CP for this study. All participants need permission from a parent or caregiver.  

You may qualify if you are 5-17 years of age, were premature, have CP that affects the legs, can walk 20 feet with or without a hand held device. You do not qualify if you take balcofen, had recent surgery, a medical condition that prevents you from exercising, botox injections in the last 4 months or you need to have botox regularly. For the brain scan you cannot be pregnant, claustrophobic, or have any metal fragments, wires, electrodes, etc in your brain or on any part of your skin or body.   

There is no cost to participate and compensation is offered to those who participate. If you are interested in learning more about this study, please contact Ms. Sara Sadeghi sadeghifs@mial.nih.gov or at (301) 451-7529. The federal relay TTY number is 1-866-411-1010. You can find more information at www.clinicaltrials.gov.