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RecruitingNCT02846272DTI/SEPUpdated Dec 11, 2024

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

An interventional study of Observation in Intractable Epilepsy, sponsored by The University of Texas Health Science Center, Houston. Recruiting at 1 site in United States. Open to participants aged 0 Days to 18 Years. Per ClinicalTrials.gov, last updated 2024-12-11.

Sponsored by The University of Texas Health Science Center, Houston · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
0 Days to 18 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Intractable Epilepsy
03

In context

Epilepsy

1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.

This study's planned enrollment of 50 is close to the median of 50 across 1,206 interventional studies indexed under Epilepsy.

Browse Epilepsy studies →

Lead sponsor

The University of Texas Health Science Center, Houston is the lead sponsor of 880 studies on the registry; 209 are open to participants now.

Of its 170 completed or terminated interventional studies of FDA-regulated products, 140 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Days to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Children diagnosis with Intractable Epilepsy

Exclusion criteria

Exclusion Criteria:

  • No Intractable Epilepsy
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Observational cohort

    Observing MRI changes in subjects.

    Procedure: Observation

Interventions

  • ProcedureObservation

    Observation of MRI changes in subjects

06

What researchers measure

Primary outcomes

  1. Number of participants with seizure outcome as determined by Engel

    Time frame: 5 years

07

Study locations

1 of 1 sites recruiting
  • UTHealth & Children's Memorial Hermann Hospital
    Houston, Texas 77030, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 11, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02846272
Lead sponsor
The University of Texas Health Science Center, Houston
Responsible party
Manish Narendra Shah (M.D. , Assistant Professor, The University of Texas Health Science Center, Houston) — Principal investigator
First posted
Jul 27, 2016
Start date
Nov 2015
Primary completion
Jan 1, 2030 (estimated)
Completion
Jan 1, 2031 (estimated)
Last update
Dec 11, 2024

Study contacts

Manish N Shah, M.D.
Contact
Manish.N.Shah@uth.tmc.edu
713 500-7410
Bangning L Yu, R.N., PhD
Contact
Bangning.Yu@uth.tmc.edu
713 500-7363
Manish N Shah, M.D.
principal investigator · UTHealth Medical School

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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