Noninvasive Pre-surgical Evaluation of Patients With Focal Epilepsy and Establishment of a Normative Imaging Database

Launched by NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE (NINDS) · Apr 5, 2014

Keywords

ClinConnect Summary

This clinical trial is focused on understanding how different imaging techniques can help locate the areas in the brain that cause seizures in patients with focal epilepsy. Researchers want to compare the effectiveness of these imaging methods before and after surgery, and they will also create a database using images from healthy volunteers to help set normal standards for these tests. The study will involve around 300 individuals aged 8 and older who have uncontrolled focal epilepsy and 200 healthy volunteers. Participants will undergo several MRI scans and cognitive tests both before and after any surgical treatment.

To be eligible for this study, patients must be at least 8 years old, have been evaluated for epilepsy surgery, and have documented evidence of focal epilepsy. Healthy volunteers can also participate if they meet similar age criteria and do not have any conditions that would make MRI unsafe. Participants can expect to have multiple visits for imaging and testing, and their involvement may help improve future treatments for epilepsy by providing valuable insights into how the brain functions in those with and without the condition.

Gender

ALL

Eligibility criteria

• * INCLUSION CRITERIA FOR PATIENTS:
• • Age 8 and older
• • Evaluated or under evaluation for epilepsy surgery under protocol 18-N-0066,11-N-0051 or 16-N-0041
• • Documentation of focal epilepsy based on MRI, EEG and/or ictal semiology
• • Ability to give informed consent, have or be able to assign a legally authorized representative able to give consent (for adults without consent capacity), or parent/guardian able to provide informed consent (for a child).
• INCLUSION CRITERIA FOR PATIENTS SOLELY CONTRIBUTING DATA:
• • Had epilepsy surgery with presurgical evaluation under 18-N-0066
• • Age 8 and up at the time of epilepsy surgery evaluation
• • Had a preoperative structural brain MRI of the type used in this protocol
• INCLUSION CRITERIA FOR HEALTHY VOLUNTEERS:
• • Age 8 and older
• • Ability to give informed consent or have a parent/guardian able to provide informed consent if a child.
• • Ability to cooperate with MRI scanning without anesthesia
• EXCLUSION CRITERIA FOR PATIENTS:
• • Contraindications to MRI or MEG studies (such as pacemakers, cochlear implants, shrapnel, permanent eyeliner)
• • Claustrophobia or anxiety disorders exacerbated by the MRI scanner
• • Pregnancy. All females of childbearing potential must have a negative pregnancy test prior to MRI scanning
• EXCLUSION CRITERIA FOR PATIENTS SOLELY CONTRIBUTING DATA:
• • -Not able or willing to give consent or do not have an appropriate surrogate who can provide consent
• EXCLUSION CRITERIA FOR HEALTHY VOLUNTEERS:
• • Contraindications to MRI or MEG studies (such as pacemakers, cochlear implants, shrapnel, permanent eyeliner)
• • Claustrophobia or anxiety disorders exacerbated by the MRI scanner
• • Significant medical conditions that may affect the central nervous system, such as psychiatric disorders (such as mood disorders, psychotic disorders, substance abuse or dependence), significant neurologic disorders (such as brain injury, neurodegenerative disorders, multiple sclerosis, stroke, movement disorders, epilepsy), or active systemic disease that may affect the central nervous system (such as uncontrolled hypertension, autoimmune disorders or other inflammatory disorders, neoplastic disease)
• • Use of centrally acting medications in the past 6 weeks, such as benzodiazepines, barbiturates, antidepressants, beta-blockers, and drugs for treating epilepsy or migraine
• • Pregnancy. All females of childbearing potential must have a negative pregnancy test prior to MRI scanning