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Monitoring Patients With Uncontrolled Epilepsy
This study has been completed.
Sponsored by: National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00001149
  Purpose

This study is designed to evaluate patients with uncontrolled seizures. Seizures can be associated with and monitored by abnormal electrical activity in the brain.

In this study researchers will use video-electroencephalography (EEG) to monitor patients with uncontrolled or suspected seizures. EEG works by measuring electrical activity in different areas of the brain. The video-EEG allows researchers to examine changes in the EEG along with the clinical features of seizures as they occur.

In addition to monitoring electrical activity of the brain, researchers will take frequent antiepileptic drug blood levels. These measures will allow researchers to learn more about how each drug is absorbed and metabolized in the body.

The information collected in the study will be used to place patients into other scientific studies testing new therapies for epilepsy.


Condition
Epilepsy
Seizures

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy pyridoxine-dependent epilepsy
MedlinePlus related topics: Epilepsy Seizures
U.S. FDA Resources
Study Type: Observational
Official Title: Monitoring of Seizures, EEG and Serum Antiepileptic Drug Concentrations in Patients With Uncontrolled Epilepsy

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 900
Study Start Date: November 1975
Estimated Study Completion Date: January 2002
Detailed Description:

In this study we will use standard clinical studies, including simultaneous Video-EEG monitoring, to evaluate patients referred for uncontrolled or suspected seizures. The protocol will be used to screen patients for inclusion in other protocols, follow the natural history of seizure disorders, and train fellows in the evaluation and treatment of epilepsy. Both inpatients and outpatients will be studied.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

History of uncontrolled seizures, at the present time, at least during 6 months of the past 3 years, and preferably a continuous pattern of seizures during the few months prior to admission.

Seizure frequency, by history, must be sufficient to make video monitoring effective. Priority will be given to patients whose seizures occur once or more per day.

Patients of any age may be accepted.

Patients (and parents or guardians, if applicable) must express willingness to cooperate with the entire protocol, to be willing to undergo further diagnostic tests if needed, and to return for follow up evaluation at intervals as needed.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00001149

Locations
United States, Maryland
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Publications:
Study ID Numbers: 750124, 75-N-0124
Study First Received: November 3, 1999
Last Updated: March 3, 2008
ClinicalTrials.gov Identifier: NCT00001149  
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Anticonvulsants
Intensive Monitoring
Epilepsy

Study placed in the following topic categories:
Signs and Symptoms
Epilepsy
Seizures
Neurologic Manifestations
Central Nervous System Diseases
Brain Diseases

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on January 15, 2009