Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01212068
Other study ID # 100211
Secondary ID 10-DC-0211
Status Terminated
Phase N/A
First received September 29, 2010
Last updated October 5, 2017
Start date September 10, 2010
Est. completion date April 4, 2017

Study information

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

Clinical 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. 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.


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.


Recruitment information / eligibility

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

Study Design


Locations

Country Name City State
United States National Institutes of Health Clinical Center, 9000 Rockville Pike Bethesda Maryland

Sponsors (1)

Lead Sponsor Collaborator
National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

United States, 

References & 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. — 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

Outcome

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
See also
  Status Clinical Trial Phase
Completed NCT04595513 - Stopping TSC Onset and Progression 2: Epilepsy Prevention in TSC Infants Phase 1/Phase 2
Completed NCT02909387 - Adapting Project UPLIFT for Blacks in Georgia N/A
Completed NCT05552924 - Self Acupressure on Fatigue and Sleep Quality in Epilepsy Patients N/A
Terminated NCT01668654 - Long-term, Open-label Safety Extension Study of Retigabine/Ezogabine in Pediatric Subjects (>= 12 Years Old) With POS or LGS Phase 3
Not yet recruiting NCT05068323 - Impact of Interictal Epileptiform Activity on Some Cognitive Domains in Newly Diagnosed Epileptic Patients N/A
Completed NCT03994718 - Creative Arts II Study N/A
Recruiting NCT04076449 - Quantitative Susceptibility Biomarker and Brain Structural Property for Cerebral Cavernous Malformation Related Epilepsy
Completed NCT00782249 - Trial Comparing Different Stimulation Paradigms in Patients Treated With Vagus Nerve Stimulation for Refractory Epilepsy N/A
Completed NCT03683381 - App-based Intervention for Treating Insomnia Among Patients With Epilepsy N/A
Recruiting NCT05101161 - Neurofeedback Using Implanted Deep Brain Stimulation Electrodes N/A
Active, not recruiting NCT06034353 - Impact of Pharmacist-led Cognitive Behavioral Intervention on Adherence and Quality of Life of Epileptic Patients N/A
Recruiting NCT05769933 - Bridging Gaps in the Neuroimaging Puzzle: New Ways to Image Brain Anatomy and Function in Health and Disease Using Electroencephalography and 7 Tesla Magnetic Resonance Imaging
Not yet recruiting NCT06408428 - Glioma Intraoperative MicroElectroCorticoGraphy N/A
Not yet recruiting NCT05559060 - Comorbidities of Epilepsy(Cognitive and Psychiatric Dysfunction)
Completed NCT02952456 - Phenomenological Approach of Epilepsy in Patients With Epilepsy
Completed NCT02646631 - Behavioral and Educational Tools to Improve Epilepsy Care N/A
Completed NCT02977208 - Impact of Polymorphisms of OCT2 and OCTN1 on the Kinetic Disposition of Gabapentin in Patients Undergoing Chronic Use Phase 4
Recruiting NCT02539134 - TAK-935 Multiple Rising Dose Study in Healthy Participants Phase 1
Completed NCT02491073 - Study to Evaluate Serum Free Thyroxine (FT4) and Free Triiodothyronine (FT3) Measurements for Subjects Treated With Eslicarbazeine Acetate (ESL) N/A
Terminated NCT02757547 - Transcranial Magnetic Stimulation for Epilepsy N/A