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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
Must not have
No Intractable Epilepsy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

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.
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.
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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have uncontrollable epilepsy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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
9%
Late RT Toxicity: Brain: NOS
9%
Headache
7%
Late RT Toxicity: Skin: NOS
6%
Memory loss
1%
Dyspnea (shortness of breath)
1%
Hemorrhage-Other
1%
Ataxia (incoordination)
1%
Mood alteration-depression
1%
Pain-Other
100%
80%
60%
40%
20%
0%
Study treatment Arm
Prophylactic Cranial Irradiation (PCI)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~25810

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
950 Previous Clinical Trials
344,995 Total Patients Enrolled
8 Trials studying Epilepsy
459 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
~18 spots leftby Jan 2030
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