Research & Clinical Trials

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Ask Children»

Assess Specific Kinds of Children Challenges in Neurology Devices - 09-555

This study sponsored by the FDA will evaluate scientific and medical issues pertaining to children undergoing treatment with a medical device. The ASK CHILDREN study is intended to aid in future development of various prostheses. The FDA seeks to use the information obtained to identify more efficient strategies in the evaluation and review of these devices regulated by the Agency. This study will focus primarily on children ages 7-15 with neurological devices such as VP shunt, the Cochlear implant, DBS for dystonia, Spinal Cord stimulator post spinal cord injury, VNS for epilepsy.

Primary Investigator: Dr. Neil Friedman 216.444.6772

VIPS Study»

Vascular effects of infection in pediatric stroke.

The purpose of the study is to examine the association between infection and arterial ischemic stroke (AIS) in children aged 1 month to the 19th birthday, 480 will be enrolled over three years at 25 sites.

Primary Investigator: Dr. Neil Friedman 216.444.6772

Zomig Study»

A Multicenter, Double-blind, Randomized, Placebo-controlled, 4-Armed Parallel Group Study to Evaluate the Efficacy of Zolmitriptan 0.5-, 2.5- and 5-mg Nasal Spray in the Treatment of Acute Migraine Headache in Adolescents. Male and female adolescent patients, Age 12 to 17 years, with an established diagnosis of migraine.

The primary objective of this study is to compare the efficacy of zolmitriptan nasal spray 0.5-, 2.5-, and 5-mg with placebo in the acute treatment of migraine headache in adolescents (aged 12 to 17), as measured by the primary outcome variable of pain-free status at two hours post treatment.

Primary Investigator: Dr. David Rothner 216.444.5514

Natural History of Duchene Muscular Dystrophy Patients on Corticosteroids that Best Describes Decline in Function and Strength»

IRB #09-969

The objective is to identify the most powerful outcomes measures for DMD patients on corticosteroids that best describes decline in function and strength.

Primary Investigator: Dr. Neil Friedman 216.444.6772

New Daily Persistent Headaches in Children and Adolescents»

Incidence and follow-up. IRB #08-792
  1. Collect data from a large group of adolescents with NDPH.
  2. Stratify data by age and sex.
  3. Review data for predisposing conditions, pre-existing headaches, description of current headache and co-existing problems.
  4. Analyze if diagnostic studies, such as blood tests, MRI, etc. are of any significant value (5) Record proposed treatment and outcomes with follow up of current condition of the headache.

Primary Investigator: Dr. David Rothner 216.444.5514

Neurofibromatosis Database »

IRB #09-676

Primary Investigators: Dr. Manikum Moodley and Dr. David Rothner

Study Coordinator: Donna Carter 216.445.5579

Childhood Stroke »

IRB #7379

Review demographics, stroke subtypes, investigations and treatment of childhood stroke.

Primary Investigator: Dr. Neil Friedman 216.444.6772

Pediatric Stroke Registry »

IRB #7638

To establish a Pediatric Stroke Registry within Northeast Ohio.

Primary Investigator: Dr. Neil Friedman 216.444.6772

The Pompe Registry »

IRB #09-904

The Pompe Registry is an ongoing, observational program sponsored by Genzyme that tracks the natural history and outcomes of patients with Pompe disease. Participation is open to all physicians managing patients with Pompe disease. Physicians are encouraged to collaborate, share observations, generate hypotheses for evaluation and assist in the collection of clinical data in an effort to guide and assess future therapeutic interventions. The Pompe Registry was established to better understand the variability and progression of Pompe disease and to continue to monitor and evaluate treatments.

Primary Investigator: Dr. Gary Hsich 216.444.4899

Sleep Disorders and Headache: The Relationship in Children»

An investigation concerning the relation of sleep disorders and headache and their effects on children.

Primary Investigator: Dr. David Rothner 216.444.5514

Quantitative Caffeine Intake in Adolescents with Headaches»

IRB #08-824

There is little to no data examining the amount of caffeine ingested amongst adolescents with headaches of all classifications.

Primary Investigator: Dr. David Rothner 216.444.5514

Pediatric Menstrual Migraine »

IRB #09-627

With our questionnaire, we hope to show that there are less patients under the age of 18 who suffer from menstrual migraine than the literature suggests.

Primary Investigator: Dr. David Rothner 216.444.5514

Posterior Reversible Encephalopathy Syndrome (PRES) in 3 Children »

IRB #08-928

To delineate clinical profile, MRI findings and management of three children with posterior reversible encephalopathy syndrome (PRES).

Primary Investigator: Dr. Manikum Moodley 216.444.3135

Neuromyelitis Optica (NMO) in Children »

IRB #09-185

To report varied clinical characteristics associated with NMO antibody in pediatric patients.

Primary Investigator: Dr. Manikum Moodley 216.444.3135

Intercranial Complications of Sinusitis in Children »

IRB #09-591

A 10 year retrospective chart review of children admitted to Cleveland Clinic with a diagnosis of sinusitis.

Primary Investigator: Dr. Manikum Moodley 216.444.3135

Relationship Between Vaccinations and Preceding Illnesses to Neuromyelitis Optica and other Demyelinating Disorders»

IRB #09-634

Looking at the correlation between vaccination and prior infections to NMO and other demyelinating disorders.

Primary Investigators: Dr. Ngoc Minh Le and Dr. Manikum Moodley 216.444.3135

Retrospective Study of the Neurologic Comorbidities Associated with Children with Downs Syndrome»

A chart review of children seen at Cleveland Clinic over the past 10 years looking at neurologic conditions associated with downs syndrome.

Primary Investigators: Dr. Ninon Pachikara and Dr. Manikum Moodley 216.444.3135

Headache in Children and Adolescents with Neurofibromatosis Type 1»

IRB #09-601

It is a goal of this study to provide more knowledge and increase awareness among clinicians of the relationship between headache and NF-1.

Primary Investigator: Dr. David Rothner 216.444.5514

Outcomes of Epilepsy Surgery in Children with Poorly Localized Preoperative Ictal and Interictal EEG»

IRB #8604

The purpose of this study is to discover the outcome of Epilepsy surgery on children with poorly localized pre-op Ictal -interictal EEG.

Primary Investigator: Dr. Elaine Wyllie 216.444.2095

Autism Standards Project»

Developing standards for diagnostic evaluation and medical/psychological care of all patients with autism. Prospective data collection.

Primary Investigator: Dr. Sumit Parikh 216.444.1994

Transverse Myelitis »

A retrospective review of children less than 21 years of age with acute transverse myelitis

Primary Investigator: Dr. Manikum Moodley 216.444.3135

Children with Atypical Teratoid Rhabdoid Tumors »

IRB #09-1070

A 20 year retrospective review of the historical clinical, investigations, management and outcomes of children less than 18 years of age admitted to Cleveland Clinic Children's with atypical teratoid rhabdoid.

Primary Investigator: Dr. Manikum Moodley 216.444.3135

Children with NF1 »

A 20 Year Retrospective Review, IRB #09-1061

A retrospective review of patients with NF1 seen over a 20 year period with abnormalities of the brainstem, basil ganglia, and cerebellum.

Primary Investigator: Dr. Manikum Moodley 216.444.3135

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