SeizEAR Safety Study
Recruiting · NCT07088835 · Interventional (participants receive a specific treatment) · Lead sponsor: Icahn School of Medicine at Mount Sinai
View the official record on ClinicalTrials.gov →Interventions studied
SeizEAR
What this trial is about
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.
Who can take part
Age range
18 Years to 70 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed across 1 US state.
- Icahn School of Medicine at Mount Sinai - New York, New York, United States