Connectivity Analysis for Investigation of Auditory Impairment in Epilepsy

NCT01212068 | Terminated

• 2 other identifiers: 10021110-DC-0211
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Brain Mapping; Intracranial Central Nervous System Disorder; Epilepsy; Auditory Perceptual Disorder; Hearing Disorder

Keywords

MEG; Epilepsy; Brain Imaging; Brain Scan; Auditory Processing; Auditory Perceptual Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Secondary outcome measures were to consist of relationships between the intracranial ECoG connectivity measures and the MEG connectivity measures.

  12-18 months

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute on Deafness and Other Communication Disorders (NIDCD): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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.

  PMID: 18632934 BACKGROUND

• 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. doi: 10.1111/j.0953-816X.2004.03431.x.

  PMID: 15182317 BACKGROUND

• 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. doi: 10.1016/s0010-9452(08)70270-3.

  PMID: 15871598 BACKGROUND

MeSH Terms

Conditions

Epilepsy; Auditory Perceptual Disorders; Hearing Disorders

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Auditory Diseases, Central; Retrocochlear Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Sensation Disorders

Study Officials

• Barry Horwitz, Ph.D.

  National Institute on Deafness and Other Communication Disorders (NIDCD)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2010
• First Posted: September 30, 2010
• Study Start: September 10, 2010
• Study Completion: April 4, 2017
• Last Updated: October 6, 2017

Record last verified: 2017-04-04

Locations

US (1)