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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 2022 Phase 3 trial • 727 Patients • NCT02085408
98%
White blood cell decreased
96%
Platelet count decreased
94%
Neutrophil count decreased
91%
Anemia
73%
Aspartate aminotransferase increased
71%
Alanine aminotransferase increased
59%
Blood bilirubin increased
55%
Febrile neutropenia
46%
Alkaline phosphatase increased
34%
Hypomagnesemia
26%
Creatinine increased
23%
Lymphocyte count decreased
12%
Lung infection
12%
Hypermagnesemia
8%
Sepsis
8%
Hypokalemia
7%
Hypophosphatemia
6%
Dyspnea
6%
Rash maculo-papular
5%
Fatigue
5%
Hypoxia
5%
Infections and infestations - Other
5%
Hypotension
5%
Hypocalcemia
4%
Acute kidney injury
4%
Catheter related infection
4%
Hyponatremia
4%
Anorexia
4%
Diarrhea
3%
Hypertension
3%
Hyperglycemia
3%
Generalized muscle weakness
3%
Hypoalbuminemia
3%
Respiratory failure
3%
Urinary tract infection
2%
Atrial fibrillation
2%
Enterocolitis infectious
2%
Epistaxis
2%
Nausea
1%
Acidosis
1%
Skin infection
1%
Soft tissue infection
1%
Multi-organ failure
1%
Confusion
1%
Pruritus
1%
Enterocolitis
1%
Non-cardiac chest pain
1%
Cardiac disorders - Other, specify
1%
Rectal hemorrhage
1%
Edema limbs
1%
Intracranial hemorrhage
1%
Investigations - Other, specify
1%
Heart failure
1%
Sinus tachycardia
1%
Supraventricular tachycardia
1%
Colitis
1%
Vomiting
1%
Upper respiratory infection
1%
Weight loss
1%
Bone pain
1%
Pain in extremity
1%
Headache
1%
Hiccups
1%
Pulmonary edema
1%
Adult respiratory distress syndrome
1%
Left ventricular systolic dysfunction
1%
Sinusitis
1%
Blood and lymphatic disorders - Other
1%
Dehydration
1%
Tumor lysis syndrome
1%
Stroke
1%
Syncope
1%
Vasovagal reaction
1%
Abdominal pain
1%
Thromboembolic event
1%
Mucositis oral
1%
Lower gastrointestinal hemorrhage
1%
Typhlitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm B (Induction: Clofarabine)
Arm F (Maintenance: Decitabine)
Arm A (Induction: Daunorubicin + Cytarabine)
Arm C (Consolidation: Cytarabine)
Arm D (Consolidation: Clofarabine)
Arm E (Maintenance: Observation)
Arm G (Transplant)

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
2011
Completed Phase 3
~26420

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
957 Previous Clinical Trials
347,802 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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