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Evaluation and Treatment of Patients with Epilepsy - Article


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Epilepsy

Seizure Disorders 




Clinical Trial: Evaluation and Treatment of Patients with Epilepsy

This study is currently recruiting patients.

Sponsored by: National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by: Warren G Magnuson Clinical Center (CC)

Purpose

This protocol has three purposes: 1) to screen patients with seizures for participation in research studies of NINDS's Clinical Epilepsy Section (CES), 2) to follow the natural course of seizure disorders, and 3) to train CES fellows in evaluating and treating epilepsy. Only standard diagnostic tests and treatments will be used in this study.

Patients of any age with seizures who are referred to CES may participate in this study. At the end of the study, patients may be discharged to the care of their referring physician, offered participation in another NINDS research protocol, or followed for teaching purposes.

Participants will undergo standard diagnostic procedures used to determine the type of their seizures, what part of the brain they are coming from, what is causing them, and whether standard drug treatments can help them. These may include some or all of the following:

- Physical and neurological examination

- Neuropsychological tests - tests of learning and memory

- Electroencephalography (EEG) - brain wave recording

- Evoked potentials - tests of nerve reactions to lights and sounds

- Polysomnography - simultaneous recordings of brain waves, breathing and eye movements

- Video-EEG monitoring - simultaneous recording of seizures using a video camera and brain waves

- Video-EEG monitoring with extra electrodes to record muscle activity, breathing and eye movements for analyzing sleep patterns

- Imaging studies, such as magnetic resonance imaging (MRI) and positron emission tomography (PET) scans to examine the structure and function of the brain

- Frequent blood tests to measure blood levels of anti-seizure drugs

Condition
Epilepsy

MedlinePlus related topics:  Epilepsy

Study Type: Observational
Study Design: Screening

Further Study Details: 

Expected Total Enrollment:  425

Study start: March 28, 2001

In this protocol we will use standard clinical studies, including neurologic examination, antiepileptic drug levels, clinical neurophysiology (EEG, EMG, evoked potentials, simultaneous Video-EEG monitoring, polysomnography), computed tomography, structural functional, and spectroscopic magnetic resonance imaging, and other studies, such as FDG-PET (performed by nuclear medicine as a clinical procedure) and neuropsychological testing, to evaluate patients referred for uncontrolled or suspected seizures. Tests will be performed in patients when clinically indicated. 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

Criteria

INCLUSION CRITERIA:
All patients older than 2 years referred to the Clinical Epilepsy Section will be included for outpatient screening.
Patients likely to be candidates for specific research protocols may be admitted for video-EEG monitoring or polysomnography as needed. Seizure frequency, by history, must be sufficient to make video monitoring effective.
Patients (and parents or guardians, if applicable) followed for teaching and training 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.
EXCLUSION CRITERIA:
Pregnancy

Location and Contact Information


Maryland
      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 

More Information

Detailed Web Page

Publications

Baker GA, Nashef L, van Hout BA. Current issues in the management of epilepsy: the impact of frequent seizures on cost of illness, quality of life, and mortality. Epilepsia. 1997;38 Suppl 1:S1-8. Review.

Begley CE, Famulari M, Annegers JF, Lairson DR, Reynolds TF, Coan S, Dubinsky S, Newmark ME, Leibson C, So EL, Rocca WA. The cost of epilepsy in the United States: an estimate from population-based clinical and survey data. Epilepsia. 2000 Mar;41(3):342-51.

Hanai T. Quality of life in children with epilepsy. Epilepsia. 1996;37 Suppl 3:28-32.

Study ID Numbers:  010139; 01-N-0139
Record last reviewed:  February 11, 2004
Last Updated:  March 30, 2005
Record first received:  March 30, 2001
ClinicalTrials.gov Identifier:  NCT00013845
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

Resources



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November 25, 2009



Page Updated: October 15, 2009
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