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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02846272
Other study ID # HSC-MS-15-0022
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 2015
Est. completion date January 1, 2031

Study information

Verified date May 2022
Source The University of Texas Health Science Center, Houston
Contact Manish N Shah, M.D.
Phone 713 500-7410
Email Manish.N.Shah@uth.tmc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To determine the utility of diffusion tensor magnetic resonance imaging in the preoperative workup of children with intractable epilepsy referred for surgery.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date January 1, 2031
Est. primary completion date January 1, 2030
Accepts healthy volunteers No
Gender All
Age group N/A to 18 Years
Eligibility Inclusion Criteria: - Children diagnosis with Intractable Epilepsy Exclusion Criteria: - No Intractable Epilepsy

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Observation
Observation of MRI changes in subjects

Locations

Country Name City State
United States UTHealth & Children's Memorial Hermann Hospital Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants with seizure outcome as determined by Engel 5 years
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