Research Studies

Research Studies

CEREBRAL PALSY

Children and adults with hemiplegic or diplegic types of cerebral palsy between 6 to 30 years of age are invited to participate in a study investigating brain reorganization in cerebral palsy at the National Institutes of Health (NIH), Bethesda, MD (Protocol 04-N-0098). The study involves 3 outpatient visits to NIH. Psychological testing, brain MRI, evaluation of vision and hearing, and a comprehensive evaluation of rehabilitation needs will be provided at no cost to participants.

NIH is part of the US Department of Health and Human Services. This study is carried out in compliance with testing and safety standards of US Department

of Health and Human Services.

The Brain Imaging Center at Washington University, St. Louis is recruiting children and adults, ages 10 and up, who have hemiplegic cerebral palsy to participate in a research study. Participants will feel shapes and textures while researchers take MRI images of the participant's brain. Participants will be paid for their work. If you are interested in learning more or participating in our functional MRI (fMRI) study call Jason Wingert at (314) 362-3555 or e-mail wingertj@neuro.wustl.edu

The Cerebral Palsy Research Registry is a collaborative effort between Northwestern University (specifically, the Department of Physical Therapy and Human Movement Sciences), The Rehabilitation Institute of Chicago, Children's Memorial Hospital and Evanston Hospital. We are building a database of children with cerebral palsy whose families are interested in participating in research studies. If you agree to be included in the registry, we collect some general contact information as well as a brief medical history and a few clinical measurements. The majority of this can be collected in a phone interview, but one visit to our laboratory is generally necessary to review informed consent with both the child and their guardian, and to perform the clinical assessments. This information is maintained in a protected database, and will not be included in your medical records.

If a researcher at one of these institutions is doing a study in which they need to recruit subjects with cerebral palsy, they can contact us for access to the database. Once their study has received Institutional Review Board (IRB) approval, they will be able to search for medical characteristics required their study, and be provided the contact information of subjects that match their criteria. There is no obligation to participate in any of the studies that your family is contacted about, and you can have your name listed as inactive or removed from the registry at any time. It is the goal of this registry to provide a path for families interested in research, as well as giving researchers access to a pool of subjects from which to select. For more information, please contact Theresa Sukal, t-sukal@northwestern.edu. Please include "CP Research Registry" somewhere in the subject line.

Comparison of Anticipatory Postural Adjustments in Children with Neurological Conditions and their non-disabled peers. The purpose of this research is to learn how typically developing children and those with a diagnosis of cerebral palsy or other neurological conditions organize muscle activity before initiating catching, throwing and arm swinging tasks. (These are anticipatory postural adjustments - made in anticipation of the self-initiated movements that will cause potential loss of balance.) This information may lead to more effective physical therapy treatment assisting children with neurological conditions to develop improved balance in sitting and standing.

If you give permission for your child to participate, he/she will be asked to do throwing and catching tasks while sitting and standing. Your child's ability to perform these activities or sustain his/her posture will not be changed by participating in this study. There is no pain associated with these activities.

I am recruiting typically developing children and children with a diagnosis of cerebral palsy or other neurological conditions who are between the ages of 8 - 17 years.

· The typically developing children should be able to follow verbal directions, sit, stand and walk independently.
· The children with neurological conditions should be able to follow verbal directions, sit, stand and walk independently without the use of crutches or a walker.
· The children enrolled in either group should have no other diagnosed medical conditions that would compromise their vision, neurological status or ability to participate for a period of 60 minutes.

Prior to the data collection at UIC, a licensed physical therapist will come to your home or meet you at UIC to administer two standardized test: the Gross Motor Function Measure (GMFM) and the Functional Reach Test. The scores on these tests will be released to you, at your request, but will not become part of your child's permanent record unless you choose to share them with your physician or therapist.

During the actual data collection at UIC, I will be recording patterns muscle activity in the trunk and legs, speed of arm movement, changes in body position and changes in weight bearing. To record information, I will need to put special adhesive sensors on your child's arms, legs and trunk muscles. Your child will sit or stand on a force platform so that postural sway can also be recorded. Special cables attached to his/her hips, knees and ankles joints and will be used to calculate how the joint angles change when your child throws or catches a ball. It will take about 20 minutes to attach the sensors and cables and 30 - 45 minutes to perform the activities. Each activity will be repeated 8 times, and your child will be able to take a break between activities, eat a snack and have something to drink.

Additionally, I would like to make photographs and videotapes to record the movements as he/she performs the activities. Without revealing your child's identity, these images may be used to illustrate presentations and written papers. Your decision to allow your child to participate is voluntary. For your participation in the study I can provide you with a parking validation for the lot adjacent to the UIC PT School. You child will also receive a $10.00 Boarders gift card as a thank you for participating in the study.

The data collection site will be your home and the Harry Knecht Movement Science Laboratory, Department of Physical Therapy, 1919 West Taylor Street on the campus of the University of Illinois at Chicago. If you are interested in having your child participate, please call me at 847-510-5650, and I will be happy to answer your questions or to set up an appointment.

Gay L. Girolami, PT, MS
Phone: 847-510-5650
Fax: 847-729-1116
www.pathwayscenter.org

Constraint-Induced Movement Therapy in Children with Cerebral Palsy. The Movement Science Program Columbia University is currently recruiting children with hemiplegic cerebral palsy between the ages of 4-18 to participate in a study that will test the effects of Constraint-Induced Therapy on affected hand and arm use. This study will be taking place in the Movement Science Program at Teachers College, Columbia University located in New York, NY. Therefore, residence in the Greater Metropolitan area are preferred.

if you are interested or would like more information, please contact: Jeanne Charles, Project Manager at 212-678-3332 or jrc44@columbia.edu

Walking Study for CP Subjects with AFO. This study involves an evaluation of your child's walking and energy expenditure with and without your brace (AFO). Compensation may be provided for participation. Jennifer Lelas, Spaulding Rehabilitation Hospital, 125 Nashua Street, Boston, MA 02114, Telephone: 617-573-2728, Email: jlelas@partners.org

CP AND/OR STROKE

Database for Stroke in Infants and Children
This multi-center collaborative study will establish a database of information about stroke in infants and children.

Children 0 to 18 years of age who: 1) have had an ischemic stroke after January 1, 2003; 2) have a history of spastic hemiplegic or quadriplegic cerebral palsy and X-ray evidence of ischemic stroke after January 1, 2003; or 3) are diagnosed with ischemic stroke defined by a new focal neurologic deficit lasting 24 hours or more and presumed due to vessel obstruction or narrowing may be eligible to participate this study.

Participating children have their medical and research records reviewed for information about their stroke. The information is gathered and entered into an internet database. Parents may be interviewed to obtain additional information, if needed. No identifying information is entered into the database, so that the child's participation remains anonymous. The resulting registry may allow physicians to better diagnose, treat, and prevent stroke in children, and will help in developing and conducting new clinical trials to study this disease.

Please refer to this study by ClinicalTrials.gov identifier NCT00084292

National Institute of Neurological Disorders and Stroke (NINDS), 9000 Rockville Pike, Bethesda, Maryland, 20892, United States; Recruiting Patient Recruitment and Public Liaison Office 1-800-411-1222 prpl@mail.cc.nih.gov TTY 1-866-411-1010

For more information: Detailed Web Page

Children with Porencephaly, Stroke, and Cerebral Palsy Sought for Study Investigators at the National Institute of Neurological Disorders and Stroke (NINDS) are seeking children with porencephaly, stroke, and cerebral palsy for a study of abnormal acquired and genetic coagulation factors. In the study, researchers will measure a series of potential risk factors for stroke that include autoimmune, inflammatory, and genetic clotting factor abnormalities. By identifying the factors that contribute to childhood stroke, porencephaly, and cerebral palsy, researchers hope this study will lay the groundwork for future research projects that will explore potential treatments.

Eligible patients must be less than 15 years of age with a history of porencephaly, cerebral infarction (stroke), and/or cerebral palsy and have a diagnosis of porencephaly or stroke confirmed by computed tomography (CT), magnetic resonance imaging (MRI), and/or Doppler ultrasonography.

The study consists of a 30-minute telephone interview/questionnaire and a blood sample, and will be conducted at the National Institutes of Health (NIH) Clinical Center in Bethesda, MD. All study-related expenses will be paid by the NIH. The study will be carried out under testing and safety standards of the U.S. Department of Health and Human Services.

For more information, physicians should send a referral letter and a copy of the patient's recent medical records to Dr. Karin Nelson or Dr. John Lynch, NINDS, NIH, 10 Center Drive, Building 10, Room 5S220, Bethesda, MD 20892-1447; telephone: (301) 496-1714; fax: (301) 496-2358; email: lynchj@ninds.nih.gov

EPILEPSY

Clinical Trials in Pediatric Epilepsy

SPEECH

Childhood Stroke Study at the University of Chicago: CURRENTLY NOT ACCEPTING APPLICANTS...Seeking people between the ages of 9-30 years old who experienced a stroke before age 13. Specifically, we are looking for people who have an injury to only one side of the brain. Participants will be compensated. University of Chicago Department of Pediatrics.

The Childhood Stroke Study at The University of Chicago is recruiting individuals who experienced strokes either during birth or childhood. This project aims to determine which areas of the brain are involved in processing language following an injury to one side of the brain.

In order to help us understand how the brain re-organizes and functions after childhood stroke, the project will use brain imaging and language assessments. We are looking for people between the ages of 9-30 who experienced the brain injury before age 13 years. Individuals will undergo a brain scan (fMRI) and two sessions of standardized tests. Participants will receive $200 for participating in all sessions. The project will take place at the University of Chicago Hospitals; local travel expenses and parking will be compensated.

If interested in learning more or participating in our study, please call Lauren Wineburgh (773) 834-8874. Fax (773) 834-5261. Email: Laurenfw@uchicago.edu.

Language Development Project at the University of Chicago: Is seeking children between the ages of 8 to 36 months to participate in a multi-year study of language after stroke. Conducted by the University of Chicago, Department of Psychology. For more information please email: language@listhost.uchicago.edu

STROKE

Study of Abnormal Blood Clotting in Children with Stroke. Effective treatment and prevention strategies for childhood stroke and porencephaly can only be developed once the causes are understood. There is increasing evidence that inherited and acquired coagulation abnormalities alone or in combination with environmental factors, predispose to arterial and venous thrombosis. Inherited abnormalities of factor V Leiden, prothrombin, protein C, protein S, and antithrombin III may account for many of these thromboses. At present there is little information on the existing distribution of these coagulation anomalies in children with thrombosis. Recent reports also suggest that these clotting abnormalities may be responsible for some instances of intracranial hemorrhage, porencephaly, cerebral palsy and fetal death.

This study will measure the frequency of several coagulation factor abnormalities (factor V Leiden, prothrombin 20210A, protein C, protein S, antithrombin III, and antiphospholipid antibodies) in children with a history of porencephaly and stroke, and will compare these to the prevalence of these mutations in population controls and family members. We will also describe the exogenous conditions which in concert with these coagulation factors, may have led to the development of thrombosis in these children.

Please refer to this study by ClinicalTrials.gov identifier NCT00001927

The Brain Imaging Center at Washington University, St. Louis: is recruiting children and adults, ages 6 and up, who have experienced a perinatal stroke (a stroke that occurred before, during or just after birth) to participate in a research study. Participants will play word games and thinking games while researchers take MRI images of the participant's brain. Participants will be paid for their help, and all travel expenses will be compensated. If you are interested in learning more or participating in our functional MRI (fMRI) study, please call (314) 362- 4154

NINDS study on quality of life and outcome of stroke in children. To receive a study questionnaire, phone Dr. John Lynch at 301-496-2358.

Childhood Stroke Study at the University of California, San Diego and Children’s Hospital and Health Center, San Diego: Dr. Jeffrey Max and his colleagues are seeking children ages 5-16 who have had a stroke before the age of 14 to participate in a research study. The project, “Psychiatric Aspects of Childhood Stroke,” is designed to provide more information regarding emotions, behavior, and thinking in children and adolescents who have had a stroke. Participation includes one morning or afternoon for about 3 hours of testing at Children’s Hospital and Health Center, San Diego, plus about 1 hour for an MRI appointment at a nearby MRI facility. There will be no costs for participation, including the MRI. Monetary compensation will be provided.

For more information or with interests in participating, please contact Dr. Jeffrey E. Max. Write to: 3020 Children’s Way, San Diego, CA 92123, MC5033. Telephone: (858) 966-5832 x5743. Fax: (858) 966-7704. E-mail: jmax@ucsd.edu.

DUKE UNIVERSITY MEDICAL CENTER
PEDIATRIC BLOOD & MARROW TRANSPLANT PROGRAM

Cerebral Palsy – Autologous Cord Blood Study

Duke University Medical Center is conducting a study to test whether an intravenous infusion of a
child's own cord blood cells, banked at the time of their birth, will lessen the symptoms of cerebral
palsy. Children, ages 12 months to 6 years, diagnosed with spastic cerebral palsy may be eligible
for the study if their cord blood cells were banked when they were born. The study is a randomized,
placebo-controlled, crossover trial which means that children will receive either cells or a mock
infusion of a harmless liquid and that no one involved with the child's care will know when they
actually receive their cells. Some children will receive cells at the beginning of the study and others
will receive cells one year later. All children will be evaluated at the beginning of the study and 1
and 2 years later.

A child's eligibility will be determined in consultation with the study team at Duke. To determine
initial eligibility, information about the child's cord blood and a blood test on the child and the cord
blood will need to be performed to confirm that the cord blood is the one belonging to the child and
that the cells are healthy. These tests are not part of the study. If, after review of these test results
and through phone and email consultation with the study team, the child is eligible for the study,
appointments will be arranged at Duke for evaluation by the transplant team, a pediatric neurologist
and developmental specialists, an MRI and an infusion of either cells or a placebo. All treatment is
conducted in the clinic at Duke. One year later, the child will return for repeat evaluations and a
second infusion. Children will cross over and receive whichever product they did not receive during
their first infusion. The risks of this study include placement of an intravenous line (IV), possible
sedation for the MRI and infection or allergic reactions due to infusion of the cord blood.

The costs of the evaluations and cell infusions will be covered by the study. There will be a small
supplement provided to families to help support the costs of travel and lodging, but the supplement
may not cover all of the costs for these activities. The study will be completed within 3 years of its
starting date and results will be published in peer-reviewed medical journals.

For more information about this study, please call the Duke Pediatric Blood and Marrow Transplant
Program at (919) 668-1100 or email Dr. Jessica Sun at jessica.sun@duke.edu. Study information is
also available online at clinicaltrials.gov.

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Pediatric Stroke Network - Research Studies