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Evaluation of Functional MRI and DTI (Imaging Techniques) in Children With Epilepsy and Focal Brain Lesions

Primary Purpose

Epilepsy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Functional MRI, Diffusion Tensor Imaging
Sponsored by
Children's Healthcare of Atlanta
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Epilepsy focused on measuring MRI, fMRI, Epilepsy, Pediatric

Eligibility Criteria

4 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: children with intractable epilepsy Exclusion Criteria: children requiring sedation for scanning

Sites / Locations

  • Children's Healthcare of Atlanta at Scottish Rite

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 13, 2005
Last Updated
June 24, 2011
Sponsor
Children's Healthcare of Atlanta
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1. Study Identification

Unique Protocol Identification Number
NCT00229840
Brief Title
Evaluation of Functional MRI and DTI (Imaging Techniques) in Children With Epilepsy and Focal Brain Lesions
Official Title
Advanced MR Imaging Evaluation Of Neurosurgical Candidates With Focal Abnormalities
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Children's Healthcare of Atlanta

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is being done to look at the relationship between brain structure and brain function in patients with epilepsy or focal brain lesions (abnormal areas) that require surgery. This study will look at an imaging technique called magnetic resonance imaging (MRI) for looking at the brain. Specifically, the study will look at functional MRI, which is an imaging technique that can map brain function by taking pictures of the brain as it performs different tasks such as reading, thinking, or moving a body part and diffusion tensor imaging (DTI), which will look at brain structure. These types of imaging may help us learn more about different areas of the brain and how those areas of the brain are used in children with epilepsy. We plan to study 30 children with epilepsy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
MRI, fMRI, Epilepsy, Pediatric

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Functional MRI, Diffusion Tensor Imaging

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: children with intractable epilepsy Exclusion Criteria: children requiring sedation for scanning
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Jones, PhD
Organizational Affiliation
Emory University/Children's Healthcare of Atlanta
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Healthcare of Atlanta at Scottish Rite
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States

12. IPD Sharing Statement

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Evaluation of Functional MRI and DTI (Imaging Techniques) in Children With Epilepsy and Focal Brain Lesions

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