Evaluation and Treatment of Patients With Epilepsy

• ClinicalTrials.gov Identifier: NCT00013845
• Recruitment Status: Terminated
• First Posted: April 2, 2001
• Last Update Posted: December 12, 2019
• Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)
• 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
• 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 *

• 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.

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

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