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Advanced MRI Techniques for Pediatric Epilepsy (DTI/SEP Trial)

N/A

Recruiting

Led By Manish N Shah, M.D.

Research Sponsored by The University of Texas Health Science Center, Houston

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Children diagnosed with Intractable Epilepsy

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

DTI/SEP Trial Summary

This trial looked at whether using a special kind of MRI called diffusion tensor MRI could help doctors better understand where to operate on children with intractable epilepsy.

Who is the study for?

This clinical trial is specifically for children who have been diagnosed with intractable epilepsy, which means their seizures are not controlled by medication. The study is open to those referred for surgery due to the severity of their condition.Check my eligibility

What is being tested?

The trial is observing how useful diffusion tensor magnetic resonance imaging (DT-MRI) can be in preparing for surgery in these children. DT-MRI is a type of brain scan that helps doctors see how water moves along neural pathways.See study design

What are the potential side effects?

Since this trial involves observation using MRI technology and does not include medication or invasive procedures, there are minimal side effects expected. The main concerns may relate to discomfort during the MRI.

DTI/SEP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My child has epilepsy that doesn't respond to treatment.

DTI/SEP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants with seizure outcome as determined by Engel

Side effects data

From 2016 Phase 3 trial • 356 Patients • NCT00048997

31%

Fatigue (lethargy, malaise, asthenia)

23%

Alopecia

17%

Late RT Toxicity: Other: NOS

11%

Nausea

10%

Anorexia

Late RT Toxicity: Brain: NOS

Headache

Late RT Toxicity: Skin: NOS

Memory loss

Dyspnea (shortness of breath)

Mood alteration-depression

Hemorrhage-Other

Ataxia (incoordination)

Pain-Other

100%

80%

60%

40%

20%

Study treatment Arm

Prophylactic Cranial Irradiation (PCI)

DTI/SEP Trial Design

1Treatment groups

Experimental Treatment

Group I: Observational cohortExperimental Treatment1 Intervention

Observing MRI changes in subjects.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Observation

2016

Completed Phase 3

~27420

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor

904 Previous Clinical Trials

320,910 Total Patients Enrolled

6 Trials studying Epilepsy

343 Patients Enrolled for Epilepsy

Manish N Shah, M.D.Principal InvestigatorUTHealth Medical School

Media Library

Observation Clinical Trial Eligibility Overview. Trial Name: NCT02846272 — N/A

Epilepsy Research Study Groups: Observational cohort

Epilepsy Clinical Trial 2023: Observation Highlights & Side Effects. Trial Name: NCT02846272 — N/A

Observation 2023 Treatment Timeline for Medical Study. Trial Name: NCT02846272 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are elderly patients eligible for this research project?

"This clinical study is looking to recruit participants that are aged between 0 days and 18 years old. In total, there are 104 trials available for minors and 165 studies open to seniors over 65."

Answered by AI

Is this experiment still seeking participants?

"Affirmative. Clinicaltrials.gov has documented that this research project, which was initially posted on November 1st 2015, is currently actively recruiting patients in need of treatment. The trial requires 50 volunteers at one medical centre to be filled."

Answered by AI

Are there any specific eligibility criteria for participation in this trial?

"This research project is enlisting 50 juvenile participants suffering from intractable epilepsy, aged 0 days up to 18."

Answered by AI

What is the current number of individuals involved in this research endeavor?

"Affirmative. Information hosted on clinicaltrials.gov verifies that this experiment is still searching for participants; it was first posted in November 2015 and updated most recently in May 2022, with 50 patients being sought at a single medical facility."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Manish Narendra Shah 2015. "Diffusion Tensor and Functional Connectivity Imaging in Pediatric Epilepsy: Imaging/Histology Correlation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02846272.

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