Proof of Principle for a Diagnostic Blood Test of Recurrent Seizures

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02269397

Enrollment

371

Registered

2014-10-21

Start date

2013-07-31

Completion date

2018-12-06

Last updated

2019-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy

Keywords

Epilepsy, Seizures, Diagnosis, Diagnostic, Inflammation

Brief summary

The primary goal of this observational study is to establish the accuracy of CNS-specific Assay for Recurrent Paroxysmal Events (CARPE) as a diagnostic blood test for epilepsy. The target population is patients who have been newly referred to the Penn Epilepsy Center or patients who are admitted to HUP for continuous video EEG monitoring. (Subjects without an epilepsy diagnosis will be included.) Subjects will be asked to provide consent, agree to allow the study team to collect information from their medical record, and to provide at least one blood sample.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

Healthy volunteers

Inclusion criteria

* Male/female patients aged 12 and older * Evaluation in at least one of the following settings: * Newly referred to the University of Pennsylvania Penn Epilepsy Center. These patients may not have completed any diagnostic evaluation at Penn, other than an initial physician consultation, prior to enrollment and must agree to allow the study team to collect records regarding their diagnostic evaluations (including EEG). Diagnostic evaluations may take place at Penn or outside sites * All patients who are admitted to the University of Pennsylvania for continuous video EEG (cVEEG) monitoring

Exclusion criteria

* Patients who, in the opinion of the investigator or the patients neurologist, are unable to give Informed Consent due to mental impairment or any other reason AND do not have a LAR who can give Informed Consent on their behalf. Patients aged 12-17 (inclusive) must provide assent if they are mentally capable of doing so, and must also have a caregiver who provides Informed Consent on their behalf * Patients who, in the opinion of their neurologist at the University of Pennsylvania, are not good candidates for donating blood for any reason

Design outcomes

Primary

Measure	Time frame	Description
Epilepsy diagnosis (CARPE) blood test for determining the presence of epilepsy ad in doing so, determine the threshold for diagnosis	2 years	Epilepsy diagnosis determined by three epileptologist's review of subject's medical records

Countries

United States

Outcome results