NIH Clinical Research Studies

Protocol Number: 04-N-0159

Active Accrual, Protocols Recruiting New Patients

Title:
Functional MRI (fMRI) and Diffusion Tensor Imaging (DTI) in Temporal Lobe Epilepsy
Number:
04-N-0159
Summary:
This study uses functional magnetic resonance imaging (fMRI) and diffusion tensor imaging (DTI) to examine how the brain processes tasks involving language and emotion in normal volunteers and in patients with epilepsy. MRI is a diagnostic and research tool that uses a strong magnetic field and radio waves to obtain images of body organs and tissues. The MRI scanner is a metal cylinder surrounded by a magnetic field. During the test, the subject lies on a table that can slide in and out of the cylinder. DTI involves taking pictures of the brain while the subject is at rest in order to learn about the structure of the brain. Information gained from this study will help scientists evaluate the organization of language and emotional functions in the brain.

Normal volunteers and patients with temporal lobe epilepsy 18 years of age and older who are native English speakers and who will undergo surgery for uncontrolled seizures may be eligible for this study. Candidates are initially screened by telephone, then with physical and neurologic examinations and cognitive testing.

The study has two parts, conducted 6 to 12 months apart. Each part consists of the same sets of tests described below, using fMRI and DTI. In patients with epilepsy, Part 1 is scheduled before surgery and Part 2 after surgery.

- fMRI: Subjects are asked to perform two types of tasks while they undergo fMRI. In one task, they are shown pictures of animals and tools and are asked to name them. In a second task, they are shown pictures that range in content from sexually explicit material, to human injury and surgical slides, to pleasant images of children and wildlife and are asked to decide whether they find the pictures pleasant, neutral, or unpleasant.

- DTI: Subjects relax and remain still in the MRI scanner for about 45 minutes.

- Neuropsychological testing: Subjects may be asked to complete questionnaires, take pen-and-paper or computerized tests, and perform motor tasks.

Participants may be asked to repeat the MRI studies, but not the neuropsychological tests, up to four times to investigate different brain functions or to confirm findings.

Sponsoring Institute:
National Institute of Neurological Disorders and Stroke (NINDS)
Recruitment Detail
Type: Active Accrual Of New Subjects
Gender: Male & Female
Referral Letter Required: No
Population Exclusion(s): None

Eligibility Criteria:
INCLUSION CRITERIA:

Patient Group:

Temporal lobe epilepsy (right-sided, left-sided foci) with or without lesions on a structural MRI scan.

Native English speaker.

Age 18 years or older.

Signed informed consent.

Volunteer Group:

Native English speaker.

Age 18 years or older.

Signed informed consent.

EXCLUSION CRITERIA:

Patient Group:

Medical or technical contraindications to MRI procedures (e.g. no braces, pacemakers, cochlear devices, surgical clips, etc;

History of mental retardation;

Pregnancy;

Claustrophobia;

Inability to comply with the protocol.

Volunteer Group:

Medical or technical contraindications to MRI procedures (e.g. no braces, pacemakers, cochlear devices, surgical clips, etc.);

History of neurologic or psychiatric disease or a learning or attention disorder or mental retardation.

Pregnancy.

Claustrophobia.

Inability to comply with the protocol.

Special Instructions: Currently Not Provided
Keywords:
Seizures
Language
Memory
Brain
Imaging
Recruitment Keywords:
Epilepsy
Temporal Lobe Epilepsy
Seizures
Conditions:
Epilepsy
Temporal Lobe
Investigational Drug(s):
None
Investigational Device(s):
None

Contacts:
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

Citations:
Barnes PD. Imaging of the central nervous system in pediatrics and adolescence. Pediatr Clin North Am. 1992 Aug;39(4):743-76. Review. PMID: 1635805

Basser PJ, et al. In vivo fiber tractography using DT-MRI data. Magn Reson Med. 2000 Oct;44(4):625-32. PMID: 11025519

Basser PJ, Pierpaoli C. A simplified method to measure the diffusion tensor from seven MR images. Magn Reson Med. 1998 Jun;39(6):928-34. PMID: 9621916

Active Accrual, Protocols Recruiting New Patients

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