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EpilepsyHFOsNCT00600717

Clinical Applications of High-Frequency Oscillations

An observational study of Epilepsy and Migraine, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The objective of this study is to utilize high-frequency brain signals (HFBS) to localize functional brain areas and characterize HFBS in epilepsy, migraine, and other brain disorders. Our goal is to create the world's first high-frequency MEG/EEG/ECoG/SEEG database for the developing brain. Read more about this study

Who is it for?
Ages 1 day to 69 yearsHealthy volunteers can take part
Conditions the study is for
Epilepsy, Migraine, Headache
How many people
0 participants
Where
1 siteUnited States
Study dates
1 Nov 2000to 1 Aug 2027
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 1 day to 69 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: The study will obtain MEG/EEG data from healthy subjects, recruiting only individuals without underlying health conditions. Additionally, this study will utilize clinical MEG/EEG data from patients, which are acquired as part of standard clinical care for clinical purposes. Since women, girls, and minorities are included in the population to whom recruiting materials are directed, we anticipate that subject selection will be equitable.

Who may be able to join

  • Healthy and cooperative.
  • Ages: from 1 day to 69 years (male or female).
  • Normal hearing and vision.
  • Normal hand movement.
  • No history of neurological or psychiatric diseases.
  • No family history of genetic neurological or psychiatric diseases.
  • No metal implants such as pacemakers, neuro-stimulators, cochlear implants, etc.

Who cannot join

  • Taking any medications for depression, neurologic, or psychiatric conditions.
  • Not feeling well, having epilepsy, or other brain disorders.
  • Recent concussion or head injury.
  • Presence of metal in the body, such as dental braces, which could cause "magnetic noise". A simple, quick "magnetic noise screening" can be conducted at the MEG Center to determine eligibility.
  • Presence of electrical or metal implants such as pacemakers, neuro-stimulators, or orthopedic pins or plates. The research nurse will discuss all exclusions in further detail before the magnetic resonance imaging (MRI) scan.
  • Inability to pass the pre-experimental screening.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • MEG

    Cincinnati, Ohio, 45229

Other trials in United States

About this study

Official title: Localizing Functional Brain Cortices and Epileptogenic Zones With High Frequency Brain Signals

The objective of this study is to utilize high-frequency brain signals (HFBS) to localize functional brain areas and characterize HFBS in epilepsy, migraine, and other brain disorders. Our goal is to create the world's first high-frequency MEG/EEG/ECoG/SEEG database for the developing brain. HFBS include high-gamma activation/oscillations, high-frequency oscillations (HFOs), ripples, fast ripples, spikelets, fast spikelets, and very high-frequency oscillations (VHFOs). While terminologies and frequency bands may vary among reports, both HFOs and high-gamma waves are crucial for understanding brain function and developing potential treatments for neurological disorders.

We have been developing an intelligent software platform to analyze signals from low to very high-frequency ranges across multiple frequency bands. To achieve these goals, we have developed several innovative techniques and software packages:

  • Accumulated spectrogram
  • Accumulated source imaging
  • Frequency-encoded source imaging
  • Multi-frequency analysis at source levels
  • Artificial intelligence detection of HFOs
  • Neural network analysis (Graph Theory)
  • Other techniques (e.g., Independent Component Analysis, virtual sensors) These methods enable researchers to better understand the characteristics and significance of HFOs and high-gamma brain waves, contributing to advancements in the diagnosis and treatment of neurological disorders.
Read the detailed description

The purpose of this study is to go beyond conventional analyses of brain signals in narrow frequency bands (typically 1-30 Hz) by measuring brain signals from infraslow to very fast frequencies (0.01 - 2800 Hz). Specifically, we propose to study physiological high-frequency oscillations (HFOs) in sensorimotor, auditory, visual, and language-evoked magnetic fields, and to investigate pathological HFOs in epilepsy, migraines, and other disorders. This is clinically important for several reasons.

For instance, there are 400,000 to 600,000 patients with refractory epilepsy in the United States. As these patients' seizures cannot be controlled by medication, epilepsy surgery is a potential cure. Accurate identification of ictogenic zones (the brain areas that cause seizures) is essential for favorable surgical outcomes. Unfortunately, the existing method, electrocorticography (ECoG), requires placing electrodes on the brain surface to capture spikes (typically, 14-70 Hz), which is both risky and costly. Our study aims to use magnetoencephalography (MEG) and electroencephalography (EEG) to identify ictogenic zones non-invasively. To achieve this goal, we propose detecting high-frequency (70-2500 Hz) and low-frequency (< 14 Hz) brain signals using advanced signal processing methods. Our central hypothesis is that high-frequency brain signals will lead to significantly improved rates of seizure freedom compared to spikes. This hypothesis is based on recent reports that high-frequency brain signals are localized to ictogenic zones.

Leveraging our unique resources and expertise, we plan to address four specific aims:

  1. Quantify the Spatial Concordance: We will quantify the spatial concordance between MEG and ECoG signals in both low and high-frequency ranges. We hypothesize that ictogenic zones determined by invasive ECoG can be non-invasively detected and localized by high-frequency MEG signals.
  2. Quantify the Occurrence Concordance: We will quantify the occurrence concordance between EEG and ECoG signals in both low and high-frequency ranges. We hypothesize that epileptic high-frequency signals from the ictogenic zones determined by invasive ECoG can also be non-invasively detected by EEG, although the localization of EEG may be significantly inferior to that of MEG.
  3. Improve Epilepsy Surgery Outcomes: We will determine whether epilepsy surgery based on multi-frequency signals (low-frequency brain signals, spikes, and high-frequency brain signals), instead of spikes alone, leads to better seizure outcomes. We hypothesize that epilepsy surgery guided by high-frequency brain signals detected with MEG/EEG will significantly improve surgical outcomes.
  4. Enhance Pre-surgical Planning: We will determine whether multi-frequency analyses provide more information than single-frequency analysis for estimating epileptogenic zones for pre-surgical ECoG electrode implantation. We hypothesize that covering all brain areas generating low to high-frequency epileptic activity is a prerequisite to localize multiple ictogenic zones for favorable post-surgical outcomes.

To yield definitive results, we propose a multi-center study to determine if high-frequency brain signals are new biomarkers for significantly improving epilepsy surgery outcomes. According to our pilot data, localization of epileptogenic zones with MEG high-frequency signals can increase post-operative seizure freedom by approximately 30-40%. The proposed study should result in millions of intractable epilepsy patients being seizure-free. Additionally, this study lays the foundation for using low and high-frequency brain signals as new biomarkers for the diagnosis and treatment of various other disorders (e.g., migraine, autism).

Furthermore, we will incorporate Optically Pumped Magnetometers MEG (OPM-MEG) to enhance the detection of high-frequency brain signals. OPM-MEG offers higher sensitivity and spatial resolution compared to conventional MEG, making it an invaluable tool for our research objectives.

Keywords
Magnetoencephalography(MEG), Electroencephalography (EEG), Intracranial recordings (iEEG/ECoG/SEEG), Functional Mapping, Epilepsy, Migraine, High frequency oscillations (HFOs), ripples, fast ripples, high-gamma, very high frequency oscillations (VHFOs), ultra fast oscillations, spikelet, fast spikelet, Optically Pumped Magnetometer, Wearable MEG, Multi-frequency Analysis, Frequency Encoded Source Imaging, Artificial Intelligence (AI), CUDA
Medical subject headings
Epilepsy, Migraine Disorders, Headache, Pain, Autistic Disorder, Cerebral Palsy, Brain Injuries, Traumatic, Attention Deficit Disorder with Hyperactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00600717
Study groupRoleWhat they receive
Pediatric Patients and Healthy ChildrenHealthy children without dental works. Pediatric patients with epilepsy and migraine (headache).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. epileptic foci

    Accuracy of localization of epileptic foci

    Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2008 (estimated)
  2. Study start1 Nov 2000 (estimated)
  3. Primary completion1 Aug 2027 (estimated)
  4. Study completion1 Aug 2027 (estimated)

Why it stopped: No participants were enrolled to collected prospective data.

Resources

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
Other
Time perspective
Prospective
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00600717
Sponsor's protocol ID
IRB 2012-0866; 2018-8108
Other IDs
2008-1439
Acronym
HFOs
Status last verified
Feb 2026
First submitted
14 Jun 2007
Last updated
4 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Kotecha R, Xiang J, Wang Y, Huo X, Hemasilpin N, Fujiwara H, Rose D, deGrauw T. Time, frequency and volumetric differences of high-frequency neuromagnetic oscillation between left and right somatosensory cortices. Int J Psychophysiol. 2009 May;72(2):102-10. doi: 10.1016/j.ijpsycho.2008.10.009. Epub 2008 Nov 14.

    PubMed 19041674
  • Wang Y, Xiang J, Kotecha R, Vannest J, Liu Y, Rose D, Schapiro M, Degrauw T. Spatial and frequency differences of neuromagnetic activities between the perception of open- and closed-class words. Brain Topogr. 2008 Dec;21(2):75-85. doi: 10.1007/s10548-008-0060-7. Epub 2008 Aug 5.

    PubMed 18679788
  • Liu Y, Xiang J, Wang Y, Vannest JJ, Byars AW, Rose DF. Spatial and frequency differences of neuromagnetic activities in processing concrete and abstract words. Brain Topogr. 2008 Spring;20(3):123-9. doi: 10.1007/s10548-007-0038-x. Epub 2007 Dec 6.

    PubMed 18058218
  • Xiang J, Xiao Z. Spatiotemporal and frequency signatures of noun and verb processing: a wavelet-based beamformer study. J Clin Exp Neuropsychol. 2009 Aug;31(6):648-57. doi: 10.1080/13803390802448651. Epub 2008 Dec 22.

    PubMed 19105073
  • Guo X, Xiang J, Mun-Bryce S, Bryce M, Huang S, Huo X, Wang Y, Rose D, Degrauw T, Gartner K, Song T, Schmit J, Vargus-Adams J. Aberrant high-gamma oscillations in the somatosensory cortex of children with cerebral palsy: a meg study. Brain Dev. 2012 Aug;34(7):576-83. doi: 10.1016/j.braindev.2011.09.012. Epub 2011 Oct 21.

    PubMed 22018901
  • Korostenskaja M, Pardos M, Kujala T, Rose DF, Brown D, Horn P, Wang Y, Fujiwara H, Xiang J, Kabbouche MA, Powers SW, Hershey AD. Impaired auditory information processing during acute migraine: a magnetoencephalography study. Int J Neurosci. 2011 Jul;121(7):355-65. doi: 10.3109/00207454.2011.560312. Epub 2011 Mar 22.

    PubMed 21425948
  • Zhang R, Wu T, Wang Y, Liu H, Zou Y, Liu W, Xiang J, Xiao C, Yang L, Fu Z. Interictal magnetoencephalographic findings related with surgical outcomes in lesional and nonlesional neocortical epilepsy. Seizure. 2011 Nov;20(9):692-700. doi: 10.1016/j.seizure.2011.06.021. Epub 2011 Jul 22.

    PubMed 21782477
  • Wang Y, Xiang J, Vannest J, Holroyd T, Narmoneva D, Horn P, Liu Y, Rose D, deGrauw T, Holland S. Neuromagnetic measures of word processing in bilinguals and monolinguals. Clin Neurophysiol. 2011 Sep;122(9):1706-17. doi: 10.1016/j.clinph.2011.02.008. Epub 2011 Mar 16.

    PubMed 21414839
  • Korostenskaja M, Pardos M, Fujiwara H, Kujala T, Horn P, Rose D, Byars A, Brown D, Seo JH, Wang Y, Vannest J, Xiang J, Degrauw T, Naatanen R, Lee KH. Neuromagnetic evidence of impaired cortical auditory processing in pediatric intractable epilepsy. Epilepsy Res. 2010 Nov;92(1):63-73. doi: 10.1016/j.eplepsyres.2010.08.008. Epub 2010 Sep 21.

    PubMed 20863661
  • Meng L, Xiang J, Kotecha R, Rose D, Zhao H, Zhao D, Yang J, Degrauw T. White matter abnormalities in children and adolescents with temporal lobe epilepsy. Magn Reson Imaging. 2010 Nov;28(9):1290-8. doi: 10.1016/j.mri.2010.03.046. Epub 2010 Jul 24.

    PubMed 20656430
  • Huo X, Wang Y, Kotecha R, Kirtman EG, Fujiwara H, Hemasilpin N, Degrauw T, Rose DF, Xiang J. High gamma oscillations of sensorimotor cortex during unilateral movement in the developing brain: a MEG study. Brain Topogr. 2011 Jan;23(4):375-84. doi: 10.1007/s10548-010-0151-0. Epub 2010 Jun 25.

    PubMed 20577795
  • Wang X, Xiang J, Wang Y, Pardos M, Meng L, Huo X, Korostenskaja M, Powers SW, Kabbouche MA, Hershey AD. Identification of abnormal neuromagnetic signatures in the motor cortex of adolescent migraine. Headache. 2010 Jun;50(6):1005-16. doi: 10.1111/j.1526-4610.2010.01674.x. Epub 2010 May 7.

    PubMed 20487034
  • Chen Y, Xiang J, Kirtman EG, Wang Y, Kotecha R, Liu Y. Neuromagnetic biomarkers of visuocortical development in healthy children. Clin Neurophysiol. 2010 Sep;121(9):1555-1562. doi: 10.1016/j.clinph.2010.03.029. Epub 2010 Apr 14.

    PubMed 20395171
  • Huo X, Xiang J, Wang Y, Kirtman EG, Kotecha R, Fujiwara H, Hemasilpin N, Rose DF, Degrauw T. Gamma oscillations in the primary motor cortex studied with MEG. Brain Dev. 2010 Sep;32(8):619-24. doi: 10.1016/j.braindev.2009.09.021.

    PubMed 19836911
  • Xiang J, Liu Y, Wang Y, Kirtman EG, Kotecha R, Chen Y, Huo X, Fujiwara H, Hemasilpin N, Lee K, Mangano FT, Leach J, Jones B, DeGrauw T, Rose D. Frequency and spatial characteristics of high-frequency neuromagnetic signals in childhood epilepsy. Epileptic Disord. 2009 Jun;11(2):113-25. doi: 10.1684/epd.2009.0253. Epub 2009 May 27.

    PubMed 19473946

Questions about this trial

What is this clinical trial studying?

An observational study of Epilepsy and Migraine, run by Children's Hospital Medical Center, Cincinnati 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 6 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: withdrawn, as of the sponsor's last update on 4 Feb 2026. 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 withdrawn before enrolling participants, so there are no results.

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?

epileptic foci (time frame: one year). 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 NCT00600717, which also lists 78 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 4 Feb 2026.

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