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Tests treatment safety and results for Epilepsy
Official title SeizEAR Safety Study
ClinicalTrials.gov ID: NCT07088835
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70. Healthy volunteers may be eligible.
You may be able to join if
- Healthy Participants
- 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
You likely can't join if
- 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
See the full eligibility criteria
- Healthy Participants
- 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
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.