NCT02846272

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
57mo left

Started Nov 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress69%
Nov 2015Jan 2031

Study Start

First participant enrolled

November 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2016

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 27, 2016

Completed
13.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2030

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2031

Last Updated

December 11, 2024

Status Verified

December 1, 2024

Enrollment Period

14.2 years

First QC Date

July 8, 2016

Last Update Submit

December 5, 2024

Conditions

Intractable Epilepsy

Outcome Measures

Primary Outcomes (1)

  • Number of participants with seizure outcome as determined by Engel

    5 years

Study Arms (1)

Observational cohort

EXPERIMENTAL

Observing MRI changes in subjects.

Procedure: Observation

Interventions

ObservationPROCEDURE

Observation of MRI changes in subjects

Observational cohort

Eligibility Criteria

Age0 Days - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Children diagnosis with Intractable Epilepsy

You may not qualify if:

  • No Intractable Epilepsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UTHealth & Children's Memorial Hermann Hospital

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Drug Resistant Epilepsy

Interventions

Observation

Condition Hierarchy (Ancestors)

EpilepsyBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Manish N Shah, M.D.

    UTHealth Medical School

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Manish N Shah, M.D.

CONTACT

713 500-7410Manish.N.Shah@uth.tmc.edu

Bangning L Yu, R.N., PhD

CONTACT

713 500-7363Bangning.Yu@uth.tmc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D. , Assistant Professor

Study Record Dates

First Submitted

July 8, 2016

First Posted

July 27, 2016

Study Start

November 1, 2015

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

January 1, 2031

Last Updated

December 11, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)