The Human Epilepsy Project

Completed

Conditions studied: Focal Epilepsy

In brief

HEP is a five-year, prospective, observational study whose primary goal is to identify clinical characteristics and biomarkers predictive of disease outcome, progression, and treatment response in participants with newly treated focal epilepsy.

Key facts

Study ID

NCT02126774

Run by

NYU Langone Health

People needed

488

Starts

2012-07-01

Expected to finish

2021-07-01

Last updated by the study team

2021-07-06

Who can join

Age: 12 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Clinical seizure(s) and history consistent with focal epilepsy
• 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:
• Normal MRI with inter-ictal EEG showing focal abnormality (focal sharp waves or focal slowing)
• Normal MRI and normal inter-ictal EEG, with clinical or electrographic seizure activity on ictal EEG
• Definitive clinical history of recurrent seizures consistent with focal epilepsy, adjudicated by central reviewers, if normal MRI and normal EEG
• 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)

You may not qualify if…

• Idiopathic or symptomatic generalized epilepsy
• Any epilepsy etiology that could produce significant gliosis or brain injury and would be likely to alter biomarkers. These include:
• 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)
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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