Protocol Number: 08-N-0161

Title:

Noninvasive Language Mapping in Patients with Localization-Related Epilepsy

Number:

08-N-0161

Summary:

This study will examine how certain language skills, such as naming objects, understanding spoken language and reading are organized in the brain and how they are affected by seizures.

People with epilepsy who are considering surgery and healthy volunteers who are right-handed and between the ages of 7 and 55 may be eligible for this study. Participants undergo the following procedures twice, and, in some cases, possibly three times, in two or three visits of 2 to 4 hours each.

Neuropsychological tests: Testing includes questionnaires, pen-and-pencil or computerized tests and motor tasks.

Structural MRI: This procedure uses a strong magnetic field and radio waves to obtain pictures of brain structure. During the test, the subject lies in the scanner (a metal cylinder surrounded by a magnetic field) for about 90 minutes, wearing earmuffs to muffle knocking noises the machine makes. Subjects may be asked to lie still for up to 10 minutes at a time.

Functional MRI: This procedure is similar to structural MRI, except a coil is placed over the head and the subject performs simple tasks during the procedure. The pictures obtained show what parts of the brain are being used to perform the task. The test lasts about 60 minutes, with subjects asked to lie still for up to 10 minutes at a time.

Magnetoencephalography (MEG) and electroencephalography (EEG): For MEG, the subject sits in an MEG recording room with a cone containing magnetic field detectors lowered onto his or her head. Very small magnetic changes produced by the activity of the brain are recorded while the subject sits quietly or performs a research task. An EEG recording of the electrical activity of the brain is done at the same time as the MEG.

Sponsoring Institute:

National Institute of Neurological Disorders and Stroke (NINDS)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): None

Eligibility Criteria:

INCLUSION CRITERIA FOR PATIENTS:

a.) Age 7-55

b.) Documentation of localization-related epilepsy based on clinical, neuropsychological and imaging criteria

c.) Failure of seizures to respond to adequate therapy with at least two standard antiepileptic drugs

d.) Willingness to be considered for surgery

e.) Fluency in English. Non-native speakers may be included if their fluency is equivalent to that of a native speaker.

INCLUSION CRITERIA FOR HEALTHY VOLUNTEERS:

a.) Age 7-55

b.) Willingness to participate in and complete the study

c.) Right-handedness assessed by the Edinburg handedness inventory

d.) Fluency in English

EXCLUSION CRITERIA FOR PATIENTS:

a.) Contra-indications to MRI studies (such as pacemakers, cochlear devices, surgical clips etc. metallic implants, orthopedic pins, shrapnel, permanent eyeliner, vagus nerve stimulator)

b.) Claustrophobia or anxiety disorders exacerbated by the MRI scanner

c.) People with neurological or psychiatric disease or taking medications that would affect fMRI and MEG language studies

d.) Pregnancy. All females of child bearing potential must have a negative test prior to MRI scanning

e.) Patients on phenobarbital or chronic benzodiazepines

EXCLUSION CRITERIA FOR HEALTHY VOLUNTEERS:

a.) Contra-indications MRI studies (metallic implants, recent orthopedic pins, cochlear implants, surgical clips, cardiac pacemakers and defibrillation devices, shrapnel, permanent eyeliner, vagus nerve stimulator)

b.) Any medical condition or chronic medication that might affect fMRI or MEG language activation by affecting cerebral structure or function, such as diabetes, hypertension, antihypertensive medications, pyshcotropic agents.

c.) Pregnancy. All females of child bearing potential must have a negative test prior to MRI scanning.

Special Instructions:

Currently Not Provided

Keywords:

Epilepsy

Language

fMRI

Magnetoencephalogram

Recruitment Keyword(s):

Epilepsy

Temporal Lobe Epilepsy

Partial Epilepsy

Healthy Volunteer

HV

Condition(s):

Epilepsy

Epilepsy, Temporal Lobe

Partial Epilepsy

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Institute of Neurological Disorders and Stroke

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

Berl MM, Balsamo LM, Xu B, Moore EN, Weinstein SL, Conry JA, Pearl PL, Sachs BC, Grandin CB, Frattali C, Ritter FJ, Sato S, Theodore WH, Gaillard WD. Seizure focus affects regional language networks assessed by fMRI. Neurology. 2005 Nov 22;65(10):1604-11.

Binder JR, Swanson SJ, Hammeke TA, Morris GL, Mueller WM, Fischer M, Benbadis S, Frost JA, Rao SM, Haughton VM. Determination of language dominance using functional MRI: a comparison with the Wada test. Neurology. 1996 Apr;46(4):978-84.

Brookes MJ, Vrba J, Robinson SE, Stevenson CM, Peters AM, Barnes GR, Hillebrand A, Morris PG. Optimising experimental design for MEG beamformer imaging. Neuroimage. 2008 Feb 15;39(4):1788-802. Epub 2007 Oct 10.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Clinical Research Informatics, CC.

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