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

NCT ID: NCT02846272

Last Updated: 2024-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2031-01-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Intractable Epilepsy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Observational cohort

Observing MRI changes in subjects.

Group Type EXPERIMENTAL

Observation

Intervention Type PROCEDURE

Observation of MRI changes in subjects

Interventions

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Observation

Observation of MRI changes in subjects

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Children diagnosis with Intractable Epilepsy

Exclusion Criteria

* No Intractable Epilepsy
Minimum Eligible Age

0 Days

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Manish Narendra Shah

M.D. , Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Manish N Shah, M.D.

Role: PRINCIPAL_INVESTIGATOR

UTHealth Medical School

Locations

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UTHealth & Children's Memorial Hermann Hospital

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Manish N Shah, M.D.

Role: CONTACT

Phone: 713 500-7410

Email: [email protected]

Bangning L Yu, R.N., PhD

Role: CONTACT

Phone: 713 500-7363

Email: [email protected]

Facility Contacts

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Manish N Shah, M.D.

Role: primary

Bangning L Yu, R.N., PhD

Role: backup

Other Identifiers

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HSC-MS-15-0022

Identifier Type: -

Identifier Source: org_study_id