A Study to Assess Peripherally Circulating Plasma Proteins and Clinical Risks to Differentiate Epileptic Seizure from Psychogenic Nonepileptic Seizure
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: 19-004730
Sponsor Protocol Number: 19-004730
About this study
The purpose of this study is to confirm the results of a University of Pennsylvania pilot study indicating that the EvoScoreDX algorithm can differentiate patients suffering from psychogenic nonepileptic seizures (PNES) and epileptic seizures (ES) using identified proteins, demographics, and clinical data.
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 - ES and PNES Cohorts:
- Aged 18-59 years old, inclusive.
- Undergoing clinically indicated evaluation in the Mayo Clinic’s EMU.
- Able to provide Informed Consent OR are accompanied by a LAR who can provide informed consent on their behalf.
Exclusion Criteria - ES and PNES Cohorts:
- Age 17 or under or age 60 or over.
- Unable to provide Informed Consent, AND are not accompanied by a LAR who can provide informed consent on their behalf.
- Note that individuals who are normally able to provide consent on their own behalf but suffer from an altered mental status after a seizure may not be provide informed consent in this post-ictal state.
- Prisoners.
- Individuals known to have any of the following conditions:
- Systemic or metastatic cancers;
- Brain tumors;
- HIV or AIDS;
- Acute or chronic central nervous infections;
- Lennox-Gastaut Syndrome;
- Genetic epilepsy syndromes (including but not limited to Dravet’s Syndrome and Tuberous Sclerosis Complex);
- Central nervous system or systemic inflammatory autoimmune disorders (including but not limited to SLE, multiple sclerosis, and vasculitis).
- Individuals with intracranial recording EEG electrodes.
- Individuals who have undergone brain surgery for any reason within the past 6 months incliuding any type of invasive EEG monitoring.
Inclusion Criteria - Control Subjects:
- Aged 18-59 years old, inclusive.
- Able to provide Informed Consent.
Exclusion Criteria - Control Subjects:
- Age 17 or under or age 60 or over.
- Unable to provide Informed Consent (an LAR is not permitted to provide Informed Consent on a Control Subject’s behalf).
- Prisoners.
- Individuals known to have any of the following conditions:
- Systemic or metastatic cancers;
- Brain tumors;
- HIV or AIDS;
- Acute or chronic central nervous infections;
- Lennox-Gastaut Syndrome;
- Genetic epilepsy syndromes (including but not limited to Dravet’s Syndrome and Tuberous Sclerosis Complex);
- Central nervous system or systemic inflammatory autoimmune disorders (including but not limited to SLE, multiple sclerosis, and vasculitis).
- A history of either seizures or suspected seizures of any type (a single instance of febrile seizure prior to age 2 is allowed).
- Treatment with an anti-seizure medication, for any reason, within two months prior to providing a blood sample.
- Individuals who have undergone brain surgery for any reason within the past 6 months including any type of invasive EEG monitoring.
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