Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:58 PM
Ignite Modification Date:
2025-12-24 @ 5:58 PM
NCT ID:
NCT01212068
Eligibility Criteria:
* INCLUSION CRITERIA:
Normal peripheral hearing: pure tone air conduction thresholds less than or equal to 20 dB HL at octave frequencies between 250-8000 Hz for each ear; word recognition scores in quiet greater than or equal to 88% for each ear; normal 226 Hz tympanometry (middle ear peak pressure at 0 plus/minus 100 daPa and peak compensated static compliance of 0.3-1.5 mmho); no history of chronic otitis media, PE tubes, or hearing loss
For those participants with epilepsy - seizure onset age \> 10 years
Normal cognitive function (Full-Scale IQ \>84)
Absence of any co-morbid neurological disorder
Absence of highly magnetizable metallic implants, including highly magnetizable dental work
A negative urine pregnancy test
For participants with epilepsy scheduled or to-be-scheduled for grid implantation surgery at Johns Hopkins Hospital
EXCLUSION CRITERIA:
Evidence of neurological or psychiatric disorder that would interfere with data interpretation, including cognitive impairment
Presence of a lesion on a previous MRI, except for the following: mesotemporal sclerosis, cortical dysplasia, and dysembryoplastic neuroepithelial tumor.
Presence of highly magnetizable metallic implants, such as pacemakers, aneurysm clips, cochlear implants and shrapnel fragments, including highly magnetizable dental work, or any significant history of exposure to small metallic objects which may have become lodged in the head or neck.
For controls (healthy volunteers) only: history of speech-language disorder
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT01212068
Study Brief:
Protocol Section:
NCT01212068