NCT00001366

Brief Summary

Researchers are interested in studying if magnetic resonance imaging (MRI) is practical for locating the areas of the brain associated with language in children with epilepsy. When a region of the brain is active, it uses more fuel in the form of oxygen and sugar (glucose). As the brain uses more fuel it produces more waste products, carbon dioxide and water. Blood carries fuel to the brain and waste products away from the brain. As brain activity increases blood flow to and from the area of activity increases also. Patients participating in the study will be asked to perform tasks designed to test language skills while undergoing an MRI to detect areas of the brain using oxygen and receiving blood flow.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
230

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 1993

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1993

Completed
6.3 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 1999

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2002

Completed
Last Updated

March 4, 2008

Status Verified

September 1, 2002

First QC Date

November 3, 1999

Last Update Submit

March 3, 2008

Conditions

EpilepsySeizures

Keywords

NeuroimagingSeizuresCerebral LocalizationPartial EpilepsyEpilepsy

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Children aged 5-17 years. Partial epilepsy (localized). Ability to cooperate with task paradigms (IQ greater than 65). No cardiac pacemakers, cochlear implants, shrapnel, vascular clips, braces, or claustrophobia. No one with inability to cooperate with task paradigms.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

National Institute of Neurological Disorders and Stroke (NINDS)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Hertz-Pannier L, Gaillard WD, Mott SH, Cuenod CA, Bookheimer SY, Weinstein S, Conry J, Papero PH, Schiff SJ, Le Bihan D, Theodore WH. Noninvasive assessment of language dominance in children and adolescents with functional MRI: a preliminary study. Neurology. 1997 Apr;48(4):1003-12. doi: 10.1212/wnl.48.4.1003.

    PMID: 9109891BACKGROUND

  • Bookheimer SY, Zeffiro TA, Blaxton T, Malow BA, Gaillard WD, Sato S, Kufta C, Fedio P, Theodore WH. A direct comparison of PET activation and electrocortical stimulation mapping for language localization. Neurology. 1997 Apr;48(4):1056-65. doi: 10.1212/wnl.48.4.1056.

    PMID: 9109900BACKGROUND

  • Malow BA, Blaxton TA, Sato S, Bookheimer SY, Kufta CV, Figlozzi CM, Theodore WH. Cortical stimulation elicits regional distinctions in auditory and visual naming. Epilepsia. 1996 Mar;37(3):245-52. doi: 10.1111/j.1528-1157.1996.tb00020.x.

    PMID: 8598182BACKGROUND

MeSH Terms

Conditions

EpilepsySeizuresEpilepsies, Partial

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

November 4, 1999

Study Start

August 1, 1993

Study Completion

September 1, 2002

Last Updated

March 4, 2008

Record last verified: 2002-09

Locations

US(1)