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Pediatric Neuroscience Trials


If you would like to learn more about participating in a research study or clinical trial, email us at

Pediatric Neurosurgery

Combination Intraventricular Chemotherapy Pilot Study
Principal Investigator: David Sandberg, M.D.

Methotrexate and Etoposide Infusions into the Fourth Ventricle or Resection Cavity in Children with Recurrent Posterior Fossa Brain Tumors.” It is open to patients who are age 1 to 21 years old with recurrent medulloblastoma (PNET), recurrent ependymoma, and recurrent atypical teratoid/rhabdoid tumors involving the brain and/or spine. The study employs a novel means of treating malignant tumors that originate from the fourth ventricle: infusion of two chemotherapy agents directly into the fourth ventricle rather than systemic intravenous delivery. There will be no simultaneous systemic chemotherapy.

For more information: 02905110, under “Brain Tumor Recurrent"

If you would like additional information about this study, please contact Bangning Yu, M.D., Ph.D., by email at or by calling (713) 500-7363.

Phase I Study of Methotrexate Infusion into the Fourth Ventricle in Children with Recurrent Malignant Fourth Ventricular Brain Tumors
Principal Investigator: David Sandberg, M.D.

A Phase I dose-escalation trial with the direct administration of methotrexate into the fourth ventricle of the brain for the treatment of children with recurrent malignant fourth ventricular brain tumors.

For more information: NCT#02458339

Non-operative Management of Suspected Calvarial Langerhans Cell Histiocytosis
David Sandberg, M.D.

A prospective multi-center cohort trial to evaluate outcomes in children with probable isolated calvarial Langerhans cell Histiocytosis.

Risk of Radiation-Induced Malignancies from Computerized Tomography (CT) Scanning in Children Shunted Before 6 Years of Age
David Sandberg, M.D.

A multi-center trial looking at the risk of radiation-induced malignancies from computerized tomography (CT) scanning in children CSF shunted before 6 years of age.

An Operator-Blinded Study of the Efficacy of ShuntCheck-Micro-Pumper, a Non-Invasive Diagnostic Procedure, in Detecting Ventricular Shunt Patency or Occlusion and in Predicting Clinical Outcome in Children and Adolescents Presenting to Emergency Departments and Neurosurgery Clinics
David Sandberg, M.D.

A device to determine the diagnostic accuracy (sensitivity and specificity) of the ShuntCheck-Micro-Pumper procedure in detecting shunt patency or obstruction in symptomatic pediatric hydrocephalus patients and will compare its accuracy to the accuracy of current diagnostic procedures (most typically CT scan).

For more information: NCT#01881711

Cortical Plasticity in Spastic Diplegia after Selective Dorsal Rhizotomy
  Manish Shah, M.D.

To characterize the cortical connectivity changes in the brain of spastic diplegic children after Selective Dorsal Rhizotomy.

Diffusion Tensor and Functional Connectivity Imaging in Pediatric Epilepsy: Imaging/Histology Correlation
 Manish Shah, M.D.

To determine if diffusion tensor and functional connectivity magnetic resonance imaging helpful to better understand and diagnose intractable epilepsy in children.

The Park-Reeves Syringomyelia Research Consortium
Manish Shah M.D. A multi-center trial to further the understanding of Syringomyelia and Chiari malformations.

Completed Neurosurgery Research Trials

Methotrexate Infusion into the Fourth Ventricle in Children with Malignant Fourth Ventricle Brain Tumors: A Pilot Study
David Sandberg, M.D.

To establish the safety of direct administration of methotrexate into the fourth ventricle of the brain based upon serial neurological examinations and serial MRI scans to assess for signal changes in the brainstem or cerebellum.

For more information: NCT#01737671 

Nondisplaced Skull Fractures in Children: Is Hospital Admission Always Necessary?
David Sandberg, M.D.

To identify under what instances hospital admission is a necessity for pediatric patients diagnosed with nondisplaced skull fractures.

Correlations of Prenatal Findings of Fetal Hydrocephalus with the Need for Surgical Intervention at Birth
 David Sandberg, M.D.

Information for physicians and parents regarding the likelihood of surgical intervention and timing in children diagnosed with hydrocephalus in utero. 

Pediatric Neurology

Academic Outcomes After Traumatic Brain Injury in Children and Adolescents
Principal Investigator: Linda Ewing-Cobbs, Ph.D.

This study aims to describe the interrelationships between traumatic brain injury (TBI) severity, demographics, age at injury and academic outcomes in reading, math and written language.

Accidental and Non-accidental Pediatric Brain Injury (Child Injury Project)
Principal Investigator: Linda Ewing-Cobbs, Ph.D.

Researchers are evaluating the skill development of brain-injured children based on the age at which the traumatic brain injury (TBI) occurred. They are also assessing how biological and social factors affect outcomes in accidental and non-accidental TBI.

Medical Etiologies of Neurodevelopmental Disorders
Principal Investigator: Richard Frye, M.D.

Investigators are determining if it is possible to identify early signs of disorders in the development of the nervous system to improve diagnosis and better determine patients’ prospects of survival and recovery.

Neurobehavioral Outcome of Head Injury in Children
Principal Investigator: Linda Ewing-Cobbs, Ph.D.

The research team is examining the relationship of certain executive function deficits involving working memory, inhibition and cognitive skills to the acute severity of closed-head injury (CHI), imaging of focal brain lesions and age differences. They are also investigating how these skills are related to communication, academic achievement, adaptive behavior and psychiatric outcome of CHI in children.

Outcomes Analysis of Hypertonic Saline Versus Mannitol in Pediatric Head Trauma: A Case Control Study
Principal Investigator: Nathan Strobel, M.D.

Implementation of the use of hypertonic saline, a salt solution, began in May 2002. This retrospective chart review, conducted from February 1998 through February 2008, will provide 6 years of historical data for comparison of the use of hypertonic saline versus mannitol, a diuretic.

Safety in Autologous Stem Cell Treatment for Traumatic Brain Injury in Children
Principal Investigator: Charles Cox, M.D.

In this pilot study, researchers are determining if bone marrow aspiration, a procedure to collect bone marrow for injection into the body, can be safely performed in children who have suffered a head injury.