Brain MappingNCT01212068
Connectivity Analysis for Investigation of Auditory Impairment in Epilepsy
An observational study of Brain Mapping and Intracranial Central Nervous System Disorder, run by National Institute on Deafness and Other Communication Disorders (NIDCD) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Mapping, Intracranial Central Nervous System Disorder, Epilepsy
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2010to 4 Apr 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
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.
Read more
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.
Read the detailed description
Objective: Auditory processing disorders are common in patients with epilepsy and adversely impact verbal communication. The neural bases of auditory disorders remain poorly understood, impeding development of objective clinical tests. The overall goal of this project is to develop an objective clinical measure of auditory processing using computational modeling of functional brain connectivity. To address this goal, we will use novel functional connectivity methods to analyze magnetoencephalographic (MEG) and intracranial electrocorticographic (ECoG) recordings.
Study Population: We will acquire MEG data from 48 patients with intractable epilepsy prior to their undergoing grid electrode placement for neurosurgery evaluation at Johns Hopkins Hospital. ECoG data will be acquired at JHU under an ongoing study. Approximately half the patients will have auditory processing impairments. We will also acquire MEG from 20 healthy control subjects with no auditory processing impairment.
Design: Three planned studies use a within-subject, repeated measures design. The MEG studies will be conducted before patients have subdural electrodes implanted for intracranial mapping. The MEG studies and connectivity analyses will be performed at NIH. The ECoG studies will take place at Johns Hopkins Hospital. Data will be acquired using the same auditory stimuli and tasks for both the MEG and ECoG parts of the study. The same functional connectivity analyses will be performed on the two data sets.
Outcome measures: The main outcome measures will 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 MEG data. Secondary outcome measures will consist of relationships between the intracranial ECoG connectivity measures and the MEG connectivity measures.
- 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
- Medical subject headings
- Epilepsy, Auditory Perceptual Disorders, Hearing Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
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 ...
Measured: 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.
Measured: 12-18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2010 (estimated)
- Study start10 Sep 2010
- Study completion4 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Brain MappingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Barry Horwitz, Ph.D., Principal investigator, National Institute on Deafness and Other Communication Disorders (NIDCD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01212068
- Sponsor's protocol ID
- 100211
- Other IDs
- 10-DC-0211
- Status last verified
- 4 Apr 2017
- First submitted
- 29 Sep 2010
- Last updated
- 6 Oct 2017
- Results posted
- No
Publications
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.
PubMed 18632934Babiloni 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.
PubMed 15182317Bishop 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.
PubMed 15871598
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Connectivity Analysis for Investigation of Auditory Impairment in Epilepsy
- ClinicalTrials.gov ID
- NCT01212068
- Acronym / sponsor ID
- 100211
- 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
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 24 participants (actual)
- Lead sponsor
- National Institute on Deafness and Other Communication Disorders (NIDCD)US National Institutes of Health
- Study start
- 10 Sep 2010
- Study completion
- 4 Apr 2017
- First posted
- 30 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Objective: Auditory processing disorders are common in patients with epilepsy and adversely impact verbal communication. The neural bases of auditory disorders remain poorly understood, impeding development of objective clinical tests. The overall goal of this project is to develop an objective clinical measure of auditory processing using computational modeling of functional brain connectivity. To address this goal, we will use novel functional connectivity methods to analyze magnetoencephalographic (MEG) and intracranial electrocorticographic (ECoG) recordings.
Study Population: We will acquire MEG data from 48 patients with intractable epilepsy prior to their undergoing grid electrode placement for neurosurgery evaluation at Johns Hopkins Hospital. ECoG data will be acquired at JHU under an ongoing study. Approximately half the patients will have auditory processing impairments. We will also acquire MEG from 20 healthy control subjects with no auditory processing impairment.
Design: Three planned studies use a within-subject, repeated measures design. The MEG studies will be conducted before patients have subdural electrodes implanted for intracranial mapping. The MEG studies and connectivity analyses will be performed at NIH. The ECoG studies will take place at Johns Hopkins Hospital. Data will be acquired using the same auditory stimuli and tasks for both the MEG and ECoG parts of the study. The same functional connectivity analyses will be performed on the two data sets.
Outcome measures: The main outcome measures will 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 MEG data. Secondary outcome measures will consist of relationships between the intracranial ECoG connectivity measures and the MEG connectivity measures.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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 ...
Time frame: 12-18 months
1 secondary outcome
Secondary outcome measures were to consist of relationships between the intracranial ECoG connectivity measures and the MEG connectivity measures.
Time frame: 12-18 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2017.
- Background: PubMed 18632934Axmacher 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.
- Background: PubMed 15182317Babiloni 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.
- Background: PubMed 15871598Bishop 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.
Related trials for Brain Mapping
Recruiting
Development of Magnetic Resonance Spectroscopic Imaging Techniques for Imaging Metabolites in Human Brain and Muscle
Brain Mapping, Healthy Volunteer
Recruiting
Mapping of Human Cognition
Epilepsy, Brain Tumor
RecruitingObservational study
Study of New Magnetic Resonance Imaging Methods of the Brain
Healthy Volunteer, Magnetic Resonance Imaging
Enrolling by invitation
An Examination of Cognitive and Sensorimotor Processes in Patients With Epilepsy
Epilepsy
Not yet recruiting
Deep Brain Stimulation Guided by Brain Mapping to Treat Cognitive Impairment
Mild Cognitive Impairment (MCI), Mild Cognitive Impairment (MCI) Amnestic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barry Horwitz, Ph.D. principal investigator
National Institute on Deafness and Other Communication Disorders (NIDCD)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Mapping and Intracranial Central Nervous System Disorder, run by National Institute on Deafness and Other Communication Disorders (NIDCD) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 ... (time frame: 12-18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01212068, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2017.