NCT00081432

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 9, 2004

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 10, 2004

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 12, 2004

Completed
6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2010

Completed
Last Updated

July 2, 2017

Status Verified

April 27, 2010

First QC Date

April 10, 2004

Last Update Submit

June 30, 2017

Conditions

Keywords

SeizuresLanguageMemoryBrainImagingEpilepsyTemporal Lobe Epilepsy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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: 1635805BACKGROUND
  • Basser 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: 11025519BACKGROUND
  • 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. doi: 10.1002/mrm.1910390610.

    PMID: 9621916BACKGROUND

MeSH Terms

Conditions

EpilepsySeizuresLanguageEpilepsy, Temporal Lobe

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsCommunicationBehaviorEpilepsies, PartialEpileptic Syndromes

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

Locations