Language and Emotional Function in Patients With Temporal Lobe Epilepsy
Functional MRI (fMRI) and Diffusion Tensor Imaging (DTI) in Temporal Lobe Epilepsy
2 other identifiers
observational
20
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2004
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 9, 2004
CompletedFirst Submitted
Initial submission to the registry
April 10, 2004
CompletedFirst Posted
Study publicly available on registry
April 12, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
April 27, 2010
CompletedJuly 2, 2017
April 27, 2010
April 10, 2004
June 30, 2017
Conditions
Keywords
Eligibility Criteria
You may qualify if:
- Patient Group:
- Temporal lobe epilepsy (right-sided, left-sided foci) with or without lesion 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892, United States
Related Publications (3)
Barnes PD. Imaging of the central nervous system in pediatrics and adolescence. Pediatr Clin North Am. 1992 Aug;39(4):743-76. doi: 10.1016/s0031-3955(16)38374-2.
PMID: 1635805BACKGROUNDBasser PJ, Pajevic S, Pierpaoli C, Duda J, Aldroubi A. In vivo fiber tractography using DT-MRI data. Magn Reson Med. 2000 Oct;44(4):625-32. doi: 10.1002/1522-2594(200010)44:43.0.co;2-o.
PMID: 11025519BACKGROUNDBasser PJ, Pierpaoli C. A simplified method to measure the diffusion tensor from seven MR images. Magn Reson Med. 1998 Jun;39(6):928-34. doi: 10.1002/mrm.1910390610.
PMID: 9621916BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Sponsor Type
- NIH
Study Record Dates
First Submitted
April 10, 2004
First Posted
April 12, 2004
Study Start
April 9, 2004
Study Completion
April 27, 2010
Last Updated
July 2, 2017
Record last verified: 2010-04-27