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NCT01273129 · ClinicalTrials.gov registry record

Surgery as a Treatment for Medically Intractable Epilepsy

A clinical trial of Epilepsy and Partial Epilepsy, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).

Recruiting
Registry status
300
Enrollment target
1
Study location

NCT01273129 is a study of Epilepsy and Partial Epilepsy that is actively recruiting participants, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 300 participants, below the 951-participant average among 160 other Epilepsy trials with a reported enrollment target (68% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01273129, a study of Epilepsy and Partial Epilepsy, is actively recruiting participants, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).

RECRUITING
Registry status
300 participants
Enrollment target
1
Study location

Study Summary

Background: \- Drug resistant epilepsy is the term used to describe epilepsy that cannot be controlled by medication. Many people whose seizures do not respond to medication will respond to surgical treatment, relieving seizures completely or almost completely in one-half to two-thirds of patients who qualify for surgery. The tests and surgery performed as part of this treatment are not experimental, but researchers are interested in using the data collected as part of routine standard epilepsy care to better understand epilepsy and its treatment. Objectives: \- To use surgery as a treatment for drug resistant epilepsy in children and adults. Eligibility: \- Children and adults at least 8 years of age who have simple or complex partial seizures (seizures that come from one area of the brain) that have not responded to medication, and who are willing to have brain surgery to treat their medically intractable epilepsy. Design: * Participants will be screened with a medical history, physical examination, and neurological examination. Imaging studies, including magnetic resonance imaging and computer-assisted tomography (CT), may also be conducted as part of the screening. Participants who do not need surgery or whose epilepsy cannot be treated surgically will follow up with a primary care physician or neurologist and will not need to return to the National Institutes of Health for this study. * Prior to the surgery, participants will have the following procedures to provide information on the correct surgical approach. * Video electroencephalography monitoring to measure brain activity during normal activities within a 24-hour period. Three to four 15-minute breaks are allowed within this period. * Electrodes placed directly in the brain or on the surface of the brain to measure brain activities and determine the part of the brain that is responsible for the seizures (seizure focus). * Participants will have a surgical procedure at the site of their seizure focu

Study Locations (1)

Maryland

  • National Institutes of Health Clinical Center - Bethesda

Trial Details

FieldValue
Enrollment Target 300 participants
Start Date 2011-03-21

What the Registry Record Tells You About NCT01273129

The ClinicalTrials.gov registry entry for NCT01273129 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 951-participant average among 160 other Epilepsy trials with a reported enrollment target (68% lower). The listed sponsor is National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Epilepsy appearing as the primary indexed condition, and to 0 interventions.

NCT01273129 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT01273129 about?

NCT01273129 is a clinical study titled "Surgery as a Treatment for Medically Intractable Epilepsy". Background: \- Drug resistant epilepsy is the term used to describe epilepsy that cannot be controlled by medication. Many people whose seizures do not respond to medication will respond to surgical treatment, relieving seizures completely or almost completely in one-half to two-thirds of patients ...

What is the current status of trial NCT01273129?

This trial is currently recruiting. The enrollment target is 300 participants. The study started on 2011-03-21.

What conditions does trial NCT01273129 study?

This clinical trial studies the following conditions: Epilepsy, Partial Epilepsy, Epilepsy, Temporal Lobe.

Who is sponsoring clinical trial NCT01273129?

This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01273129 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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