Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02107989 : Noninvasive Pre-surgical Evaluation of Patients With Focal Epilepsy
PhaseN/A
AgesMin: 8 Years Max: 65 Years
Eligibility
- INCLUSION CRITERIA FOR PATIENTS:

- Age 8-65 years old

- Evaluated or under evaluation for epilepsy surgery under protocol 01-N-0139

- Documentation of focal epilepsy based on MRI, EEG and/or ictal semiology

- Failure of seizures to respond to adequate therapy with at least two standard
antiepileptic medications

- Ability to give informed consent or have 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 01-N-0139

- Age 8-65 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 8-65 years old

- 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
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02107989      |      Link to official Clinicaltrials.gov listing
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