💬In plain words
What the trial is, and whether it could suit you
Determine the safety and feasibility of an in-ear device to measure seizures or suspected seizures compared to the standard scalp-based electroencephalogram (EEG). The study team anticipates enrolling five healthy participants through meeting announcements and a research email list serv in the Neurology Dept. Based on the appropriate positive initial test of healthy individuals, test the in-ear device on 10 participants with seizures or suspected seizures scheduled for a clinical scalp EEG test.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Healthy Participants
Inclusion Criteria:
* Age: \> 18 and \<70
* No History of Seizures or seizure-like activity based on self-report
* Normal parameters for vitals, afebrile, blood pressure.
* Able to read and write English
* Capable of providing informed consent
Exclusion Criteria:
* History of seizures or seizure-like activity based on self-assessment
* Any major health conditions based upon self-report
* Concurrent participation in another investigational protocol.
* A history of skin sensitivity, or rash on the head, neck or ears.
* A history of silver allergy.
* Treatment for an ear infection in the previous four-week period
* Medications that would be contraindicated to participate in the study that would interfere with the EEG Testing
Phase 3 Inclusion/Exclusion Criteria: Participants with Seizures or Suspected Temporal Lobe Seizures
Inclusion Criteria:
* Age \> 18 and \< 70
* Individuals scheduled for clinical EEG for seizures or suspected temporal lobe seizures documented by a neurologist
* Stable Health Conditions based upon the principal investigator's opinion
* Normal parameters for vitals, afebrile, blood pressure
* Able to read and write English
* Capable of providing informed consent.
Exclusion Criteria:
* Any major issues with the skull or ear that would interfere with the EEG testing.
* A history of skin sensitivity, or rash on the head, neck or ears
* A history of silver allergy.
* Treatment for an ear infection in the previous four-week period.
* Concurrent participation in another investigational protocol
* Any psychiatric disorder (i.e. uncontrolled depression, mood disorders, cognitive impairment, schizophrenia), that complicate measurement of changes associated with the EEG testing.
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