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MEG
Noninvasive Imaging for Epilepsy
N/A
Recruiting
Led By Sara K Inati, M.D.
Research Sponsored by National Institute of Neurological Disorders and Stroke (NINDS)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients aged 8 and older
Patients who had epilepsy surgery with presurgical evaluation under a specific protocol
Timeline
Screening 3 weeks
Treatment Varies
Follow Up all outcomes in this study are exploratory.
Awards & highlights
No Placebo-Only Group
Summary
This trial will compare the sensitivities and specificities of morphometric analysis techniques using MRI images to pre- and postsurgical localization of epileptic foci in patients undergoing presurgical evaluation for medically refractory epilepsy, in order to establish an age-stratified normative imaging database.
Who is the study for?
This trial is for adults and children aged 8 or older with uncontrolled focal epilepsy, who are being evaluated for or have had epilepsy surgery. Participants must be able to consent themselves or through a guardian and cooperate with MRI scans without anesthesia.
What is being tested?
The study aims to improve the detection of epileptic foci using MRI before and after surgery in patients with refractory epilepsy. It also involves creating a database from healthy volunteers for comparison, plus additional brain imaging (MEG) and cognitive testing.
What are the potential side effects?
There are generally no direct side effects from participating in this trial as it involves noninvasive imaging techniques like MEG and MRI. However, some individuals might experience discomfort during scanning or claustrophobia.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 8 years old or older.
Select...
I had epilepsy surgery after a detailed presurgical evaluation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ all outcomes in this study are exploratory.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~all outcomes in this study are exploratory.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
All outcomes in this study are Exploratory.
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: healthy volunteersExperimental Treatment2 Interventions
healthy volunteers
Group II: PatientsExperimental Treatment2 Interventions
Patients
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MEG
2017
N/A
~1280
MRI
2009
Completed Phase 2
~2810
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Who is running the clinical trial?
National Institute of Neurological Disorders and Stroke (NINDS)Lead Sponsor
1,378 Previous Clinical Trials
651,492 Total Patients Enrolled
79 Trials studying Epilepsy
24,863 Patients Enrolled for Epilepsy
Sara K Inati, M.D.Principal InvestigatorNational Institute of Neurological Disorders and Stroke (NINDS)
5 Previous Clinical Trials
2,376 Total Patients Enrolled
3 Trials studying Epilepsy
2,318 Patients Enrolled for Epilepsy
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 8 years old or older and being evaluated for epilepsy surgery.I can give consent or have someone who can legally consent for me.I do not have major health issues affecting my brain or nerves.I haven't taken any central nervous system medications in the last 6 weeks.I had epilepsy surgery after a detailed presurgical evaluation.I am 8 years old or older.I am at least 8 years old and in good health.
Research Study Groups:
This trial has the following groups:- Group 1: healthy volunteers
- Group 2: Patients
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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