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Diffusion Tensor and Functional Connectivity Imaging in Pediatric Epilepsy: Imaging/Histology Correlation (DTI/SEP)

Primary Purpose

Intractable Epilepsy

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Observation
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Intractable Epilepsy

Eligibility Criteria

0 Days - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Children diagnosis with Intractable Epilepsy

Exclusion Criteria:

  • No Intractable Epilepsy

Sites / Locations

  • UTHealth & Children's Memorial Hermann HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Observational cohort

Arm Description

Observing MRI changes in subjects.

Outcomes

Primary Outcome Measures

Number of participants with seizure outcome as determined by Engel

Secondary Outcome Measures

Full Information

First Posted
July 8, 2016
Last Updated
May 17, 2022
Sponsor
The University of Texas Health Science Center, Houston
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1. Study Identification

Unique Protocol Identification Number
NCT02846272
Brief Title
Diffusion Tensor and Functional Connectivity Imaging in Pediatric Epilepsy: Imaging/Histology Correlation
Acronym
DTI/SEP
Official Title
Diffusion Tensor and Functional Connectivity Imaging in Pediatric Epilepsy: Imaging/Histology Correlation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 2015 (undefined)
Primary Completion Date
January 1, 2030 (Anticipated)
Study Completion Date
January 1, 2031 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To determine the utility of diffusion tensor magnetic resonance imaging in the preoperative workup of children with intractable epilepsy referred for surgery.
Detailed Description
To determine if diffusion tensor and functional connectivity magnetic resonance imaging helpful to better understand and diagnose intractable epilepsy in children. All enrolled children will undergo standard preoperative and postoperative MRI imaging, plus a 15 minute set of functional connectivity and diffusion tensor sequence with no additional sedation. This imaging data will be stripped of identifiers and be processed to provide both quantitative analysis, resting state functional connectivity changes and three dimensional modeling of white matter tracts adjacent to epileptogenic foci. This study is being done to determine if diffusion tensor and functional connectivity magnetic resonance imaging are helpful to better understand and diagnose intractable epilepsy in children.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intractable Epilepsy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Observational cohort
Arm Type
Experimental
Arm Description
Observing MRI changes in subjects.
Intervention Type
Procedure
Intervention Name(s)
Observation
Intervention Description
Observation of MRI changes in subjects
Primary Outcome Measure Information:
Title
Number of participants with seizure outcome as determined by Engel
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Days
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children diagnosis with Intractable Epilepsy Exclusion Criteria: No Intractable Epilepsy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Manish N Shah, M.D.
Phone
713 500-7410
Email
Manish.N.Shah@uth.tmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Bangning L Yu, R.N., PhD
Phone
713 500-7363
Email
Bangning.Yu@uth.tmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manish N Shah, M.D.
Organizational Affiliation
UTHealth Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
UTHealth & Children's Memorial Hermann Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manish N Shah, M.D.
Phone
713-500-7410
Email
Manish.N.Shah@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Bangning L Yu, R.N., PhD
Phone
713 500-7363
Email
Bangning.Yu@uth.tmc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Diffusion Tensor and Functional Connectivity Imaging in Pediatric Epilepsy: Imaging/Histology Correlation

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