The Human Epilepsy Project
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 12-010106
NCT ID: NCT02126774
Sponsor Protocol Number: 12-010106
About this study
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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Gregory Cascino, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available