Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
488 participants
OBSERVATIONAL
2012-07-31
2021-07-01
Brief Summary
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Detailed Description
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The Human Epilepsy Project seeks to answer these unknowns by collecting high-resolution clinical information and treatment response, MRIs, EEGs, and blood and urine samples for biomarkers. A major outcome of the project is to create an open data repository of clinical information and biologic samples for future studies.
HEP may have a transformative impact on epilepsy diagnosis and treatment by identifying critical clinical features and biomarkers at the onset of epilepsy that can be used to predict outcome and guide therapy. We hope to identify subsets of patients at high risk for pharmacoresistance who may benefit from more aggressive initial therapy and earlier consideration for surgical treatment. The existence of biomarkers that predict the likelihood of disease remission would dramatically affect treatment decisions and counseling for millions of patients.
In addition to its impact on current clinical care, the data and specimens collected in HEP, including sequential neuroimaging, electrophysiology and metabolite profiles, and banked DNA for the purpose of future genomics studies, have the potential to provide new insights into the biological basis of focal epilepsy, which will advance our efforts to discover effective treatments and cures for this disorder.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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focal epilepsy
observational study
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* At least two confirmed spontaneous seizures, at least 24 hours apart, in the 12 months prior to enrollment
* Complete AED history prior to enrollment (with approximate dates and doses) is available (exception can be made for AEDs taken for \<1 week)
* Age ≥12 years and ≤60 years at time of seizure onset
* Age ≥12 years and ≤60 years at time of enrollment
* Treatment instituted not more than 4 months prior to enrollment
* One of the following:
1. Normal MRI with inter-ictal EEG showing focal abnormality (focal sharp waves or focal slowing)
2. Normal MRI and normal inter-ictal EEG, with clinical or electrographic seizure activity on ictal EEG
3. Definitive clinical history of recurrent seizures consistent with focal epilepsy, adjudicated by central reviewers, if normal MRI and normal EEG
4. Focal lesion (non-progressive) on MRI with normal EEG (acceptable focal lesions include MTS, FCD, single cavernoma, and AVMs that are not of large size and lack significant amounts of hemosiderin)
Exclusion Criteria
* Any epilepsy etiology that could produce significant gliosis or brain injury and would be likely to alter biomarkers. These include:
1. Epilepsy with an etiology occurring in the previous two years that would produce significant CNS injury (e.g., traumatic brain injury that involves direct disruption of brain tissue, stroke, encephalitis)
2. History of intracranial bleeding (e.g., subarachnoid, intraparenchymal)
* Identified genetic epilepsy syndrome
* Presence of moderate or greater developmental or cognitive delay prior to seizure onset (e.g., if an adolescent, not in self-contained classroom; if IQ is documented, should be \> 70)
* History of chronic drug or alcohol abuse within the last 2 years
* IGE/focal epilepsy mixed syndromes
* Progressive neurological disorder (brain tumor, AD, PME, etc.)
* Major medical co-morbidities such as renal failure requiring dialysis, metastatic cancer, HIV, or significant liver or renal disease
* Autism Spectrum Disorder
* Seizures only during pregnancy
* History of previous or current significant psychiatric disorder that would interfere with conduct of the study
12 Years
60 Years
ALL
No
Sponsors
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The Epilepsy Study Consortium
OTHER
NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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Ruben Kuzniecky, MD
Role: PRINCIPAL_INVESTIGATOR
New York University, Comprehensive Epilepsy Center
Jacqueline French, MD
Role: PRINCIPAL_INVESTIGATOR
New York University, Comprehensive Epilepsy Center
Daniel Lowenstein, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco, Department of Neurology
Locations
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University of Alabama
Birmingham, Alabama, United States
University of California San Francisco
San Francisco, California, United States
Children's Hospital Colorado
Denver, Colorado, United States
Yale University
New Haven, Connecticut, United States
University of Miami
Miami, Florida, United States
Emory University
Atlanta, Georgia, United States
Johns Hopkins School of Medicine
Baltimore, Maryland, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Mid-Atlantic Epilepsy and Sleep Center
Bethesda, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Minnesota Epilepsy Group
Saint Paul, Minnesota, United States
Washington University
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Saint Barnabas Medical Center
Livingston, New Jersey, United States
North Shore-LIJ Health System
Great Neck, New York, United States
Albert Einstein College of Medicine
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
New York University Langone Medical Center
New York, New York, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Vanderbilt University
Nashville, Tennessee, United States
University of Texas
Houston, Texas, United States
Austin Hospital, University of Melbourne
Melbourne, , Australia
Royal Melbourne Hospital
Melbourne, , Australia
Prince of Wales Hospital, University of New South Wales
Sydney, , Australia
University of Western Ontario
London, Ontario, Canada
Countries
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References
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Barnard SN, Chen Z, Holmes M, Kanner AM, Hegde M, Kuzniecky R, Lowenstein D, French JA; Human Epilepsy Project (1) Investigators. Treatment Response to Antiseizure Medications in People With Newly Diagnosed Focal Epilepsy. JAMA Neurol. 2025 Aug 25:e252949. doi: 10.1001/jamaneurol.2025.2949. Online ahead of print.
Related Links
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HEP website
Other Identifiers
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12-02865
Identifier Type: -
Identifier Source: org_study_id
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