Epilepsy Clinical Trial
Official title:
Connectivity Analysis for Investigation of Auditory Impairment in Epilepsy
Verified date | April 4, 2017 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Background:
- People with epilepsy often have auditory processing disorders that affect their ability
to hear clearly and may cause problems with understanding speech and other kinds of
verbal communication. Researchers are interested in developing better ways of studying
what parts of the brain are affected by hearing disorders and epilepsy, and they need
better clinical tests to measure how individuals process sound. These tests will allow
researchers to examine and evaluate the effects of epilepsy and related disorders on
speech and communication.
- A procedure called a magnetoencephalography (MEG) can be used to measure the electrical
currents involved in brain activity. Researchers are interested in learning whether MEG
can be used to detect differences in the processing of simple sounds in patients with
epilepsy, both with and without hearing impairments.
Objectives:
- To measure brain activity in hearing impaired persons with epilepsy and compare the results
with those from people with normal hearing and epilepsy as well as people with normal hearing
and no epilepsy. This research is performed in collaboration with Johns Hopkins Hospital and
epilepsy patients must be candidates for surgery at Johns Hopkins.
Eligibility:
- Individuals between 18 to 55 years of age who (1) have epilepsy and have hearing
impairments, (2) have epilepsy but do not have hearing impairments, or (3) are healthy
volunteers who have neither epilepsy nor hearing impairments.
- Participants with epilepsy must have developed seizures after 10 years of age, and must
be candidates for grid implantation surgery at Johns Hopkins Hospital..
Design:
- This study will require one visit of approximately 4 to 6 hours.
- Participants will be screened with a full physical examination and medical history,
along with a basic hearing test.
- Participants will have a magnetic resonance imaging (MRI) scan of the brain, followed by
a MEG scan to record magnetic field changes produced by brain activity.
- During MEG recording, participants will be asked to listen to various sounds and make
simple responses (pressing a button, moving your hand or speaking) in response to sounds
heard through earphones. The MEG procedure should take between 1 and 2 hours.
- Treatment at NIH is not provided as part of this protocol.
Status | Terminated |
Enrollment | 24 |
Est. completion date | April 4, 2017 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility |
- 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 |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institute on Deafness and Other Communication Disorders (NIDCD) |
United States,
Axmacher N, Schmitz DP, Wagner T, Elger CE, Fell J. Interactions between medial temporal lobe, prefrontal cortex, and inferior temporal regions during visual working memory: a combined intracranial EEG and functional magnetic resonance imaging study. J Neurosci. 2008 Jul 16;28(29):7304-12. doi: 10.1523/JNEUROSCI.1778-08.2008. — View Citation
Babiloni C, Bares M, Vecchio F, Brazdil M, Jurak P, Moretti DV, Ubaldi A, Rossini PM, Rektor I. Synchronization of gamma oscillations increases functional connectivity of human hippocampus and inferior-middle temporal cortex during repetitive visuomotor events. Eur J Neurosci. 2004 Jun;19(11):3088-98. Erratum in: Eur J Neurosci. 2004 Sep;20(6):1694. Claudio, Babiloni [corrected to Babiloni, Claudio]; Martin, Bares [corrected to Bares, Martin]; Fabrizio, Vecchio [corrected to Vecchio, Fabrizio]; Milan, Brazdil [corrected to Brazdil, Milan]; Pavel, Jurak [corrected to Jurak, Pavel]; Vito, Moretti Davide [corrected to Moretti, Davide Vito]; Alessandra, Ubaldi [corrected to Ubaldi, Alessandra]; Maria, Rossini Paolo [corrected to Rossini, Paolo Maria]; Ivan, Rektor [corrected to Rektor, Ivan]. — View Citation
Bishop DV, McArthur GM. Individual differences in auditory processing in specific language impairment: a follow-up study using event-related potentials and behavioural thresholds. Cortex. 2005 Jun;41(3):327-41. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The main outcome measures were to be (1) functional connectivity patterns in intracranial ECoG data that differentiate epilepsy patients with auditory impairments from those without auditory impairments; and (2) corresponding patterns in ... | 12-18 months | ||
Secondary | Secondary outcome measures were to consist of relationships between the intracranial ECoG connectivity measures and the MEG connectivity measures. | 12-18 months |
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