Proof of Principle for a Diagnostic Blood Test of Recurrent Seizures
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Neurology, Neurology, Epilepsy |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 12 - Any |
| Updated: | 4/21/2016 |
| Start Date: | July 2013 |
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.
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.
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
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