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Summary

for people ages 12–60 (full criteria)
at San Fancisco, California and other locations
study started
estimated completion:

Description

Summary

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.

Details

Epilepsy is a serious disease. It affects approximately 2.4 million Americans, with a lifetime risk estimated at 3%. More than 181,000 Americans develop epilepsy every year, and a substantial proportion has seizures that cannot be controlled by available medications. For the vast majority of patients with epilepsy, we do not understand the biological basis of their disease; we do not know whether a given anti-epileptic drug (AED) will be effective; and we cannot predict the severity of the seizure disorder, the potential emergence of co-morbidities, or the likelihood of remission.

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.

Keywords

Focal Epilepsy epilepsy

Eligibility

You can join if…

Open to people ages 12–60

  • 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 CAN'T join 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

Locations

  • Children's Hospital Colorado accepting new patients
    Denver, Colorado, United States
  • University of Texas accepting new patients
    Hosuton, Texas, United States
  • University of Nebraska Medical Center not yet accepting patients
    Omaha, Nebraska, United States
  • Minnesota Epilepsy Group accepting new patients
    Saint Paul, Minnesota, United States
  • Mayo Clinic accepting new patients
    Rochester, Minnesota, United States
  • Washington University accepting new patients
    St. Louis, Missouri, United States
  • Vanderbilt University accepting new patients
    Nashville, Tennessee, United States
  • University of Alabama accepting new patients
    Birmingham, Alabama, United States
  • University of Western Ontario accepting new patients
    London, Ontario, Canada
  • University of Michigan accepting new patients
    Ann Arbor, Michigan, United States
  • Emory University accepting new patients
    Atlanta, Georgia, United States
  • Medical University of South Carolina accepting new patients
    Charleston, South Carolina, United States
  • Mid-Atlantic Epilepsy and Sleep Center accepting new patients
    Bethesda, Maryland, United States
  • Geisinger Medical Center not yet accepting patients
    Danville, Pennsylvania, United States
  • Johns Hopkins School of Medicine not yet accepting patients
    Baltimore, Maryland, United States
  • University of Maryland Medical Center not yet accepting patients
    Baltimore, Maryland, United States
  • Thomas Jefferson University accepting new patients
    Philadelphia, Pennsylvania, United States
  • University of Miami accepting new patients
    Miami, Florida, United States
  • Saint Barnabas Medical Center accepting new patients
    Livingston, New Jersey, United States
  • Albert Einstein College of Medicine accepting new patients
    New York, New York, United States
  • Columbia University Medical Center accepting new patients
    New York, New York, United States
  • New York University Langone Medical Center accepting new patients
    New York, New York, United States
  • North Shore-LIJ Health System accepting new patients
    Great Neck, New York, United States
  • Yale University accepting new patients
    New Haven, Connecticut, United States
  • Beth Israel Deaconess Medical Center accepting new patients
    Boston, Massachusetts, United States
  • Massachusetts General Hospital accepting new patients
    Boston, Massachusetts, United States
  • Austin Hospital, University of Melbourne accepting new patients
    Melbourne, Australia
  • Royal Melbourne Hospital accepting new patients
    Melbourne, Australia
  • Prince of Wales Hospital, University of New South Wales not yet accepting patients
    Sydney, Australia

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
New York University School of Medicine
Links
HEP website
ID
NCT02126774
Lead Scientist
Daniel Lowenstein
Study Type
Observational [Patient Registry]
Last Updated
October 1, 2016
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