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Evaluation and Treatment of Patients With Epilepsy

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ClinicalTrials.gov Identifier: NCT00013845
Recruitment Status : Terminated
First Posted : April 2, 2001
Last Update Posted : December 12, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )

Tracking Information
First Submitted Date March 30, 2001
First Posted Date April 2, 2001
Last Update Posted Date December 12, 2019
Study Start Date May 1, 2001
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation and Treatment of Patients With Epilepsy
Official Title Evaluation and Treatment of Patients With Epilepsy
Brief Summary

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
Detailed Description

Objectives: To evaluate patients with epilepsy

Study Population: adults and children with epilepsy

Design: 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. Standard clinical evaluation and drug treatment of epilepsy is performed under this protocol.

Outcome Measures: clinical characteristics of epilepsy

Study Type Observational
Study Design Not Provided
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition Epilepsy
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: June 27, 2018)
1278
Original Enrollment
 (submitted: June 23, 2005)
600
Study Completion Date June 26, 2018
Primary Completion Date Not Provided
Eligibility Criteria
  • INCLUSION CRITERIA:

All patients older than 2 years referred to the Clinical Epilepsy Section will be included. DPA assignment for adults without consent capacity is required at the time of enrollment.

EXCLUSION CRITERIA:

None.

Sex/Gender
Sexes Eligible for Study: All
Ages 2 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00013845
Other Study ID Numbers 010139
01-N-0139
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )
Study Sponsor National Institute of Neurological Disorders and Stroke (NINDS)
Collaborators Not Provided
Investigators
Principal Investigator: Sara K Inati, M.D. National Institute of Neurological Disorders and Stroke (NINDS)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date June 26, 2018