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NCT02107989 · ClinicalTrials.gov registry record
Noninvasive Pre-surgical Evaluation of Patients With Focal Epilepsy and Establishment of a Normative Imaging Database
A clinical trial of Epilepsy, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Recruiting
- Registry status
- 700
- Enrollment target
- 1
- Study location
NCT02107989: Recruiting study of Epilepsy, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
NCT02107989 is a study of Epilepsy that is actively recruiting participants, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 700 participants, below the 948-participant average among 160 other Epilepsy trials with a reported enrollment target (26% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02107989, a study of Epilepsy, is actively recruiting participants, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- RECRUITING
- Registry status
- 700 participants
- Enrollment target
- 1
- Study location
Study Summary
Objectives: The overall study objective is to compare the sensitivities and specificities of morphometric analysis techniques using structural MRI images based on pre- and postsurgical localization of epileptic foci in patients undergoing presurgical evaluation for medically refractory epilepsy. To carry out these analyses, we aim to establish an age-stratified normative imaging database using healthy volunteers. Additional objectives are to identify abnormal networks in these patients using resting state fMRI/EEG and MEG/EEG, and to use language and memory fMRI tasks to examine the effects of epileptogenic zones and surgery on cognitive function and the networks associated with these functions. Study population: 300 adults and children (age 8 and older) with uncontrolled focal epilepsy, and 200 age-stratified healthy volunteers. Design: A retrospective and prospective natural history study. Research procedures for patients in this study include neuropsychological testing and 1-4 MRI sessions during presurgical evaluation and an additional 1-3 MRI sessions and neuropsychological testing approximately 12 months post-operatively. Research testing (such as research neuropsychological tests or MRI scanning sequences) will be done during a visit for clinical testing whenever possible, likely reducing the number of required visits. Patients will also have optional MEG and 7T structural imaging. Data will also be obtained from patients who have already undergone epilepsy surgery if they had procedures as outlined in the protocol and are willing to share the data. Healthy volunteers will receive a subset of the pre-operative procedures for patients, requiring at least 3 visits. In order to ensure adequate data acquisition, subjects may be re-scanned up to three times for the portions of the study in which they participated, possibly requiring additional visits. Outcome measures: The main outcomes will be establishment of normative values for morphometric analysis meth
Primary Outcome
All outcomes in this study are Exploratory.
Conditions Studied
Interventions
- DEVICE MRI
- DEVICE MEG
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 700 participants |
| Start Date | 2014-03-11 |
| Est. Completion | 2028-03-30 |
What NCT02107989 shows while recruiting
NCT02107989 is an observational study that tracks outcomes without assigning an intervention. The registered 700 participants enrollment target is mid-sized for trials with a published cap, below the 948-participant average among 160 other Epilepsy trials with a reported enrollment target (26% lower).
The record links to 1 condition, with Epilepsy appearing as the primary indexed condition, and to 2 interventions - of which MRI is the first listed.
NCT02107989 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT02107989 about?
NCT02107989 is a clinical study titled "Noninvasive Pre-surgical Evaluation of Patients With Focal Epilepsy and Establishment of a Normative Imaging Database". Objectives: The overall study objective is to compare the sensitivities and specificities of morphometric analysis techniques using structural MRI images based on pre- and postsurgical localization of epileptic foci in patients undergoing presurgical evaluation for medically refractory epilepsy. To...
What is the current status of trial NCT02107989?
This trial is currently recruiting. The enrollment target is 700 participants. The study started on 2014-03-11. Estimated completion is 2028-03-30.
What conditions does trial NCT02107989 study?
This clinical trial studies the following conditions: Epilepsy.
What interventions are being tested in trial NCT02107989?
The interventions under investigation include: MRI (DEVICE), MEG (DEVICE).
Who is sponsoring clinical trial NCT02107989?
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 NCT02107989 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02107989's enrollment target sits among peer trials
700 9th of 160 higher than 151 of 160 other Epilepsy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Epilepsy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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