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Clinical Applications of High-Frequency Oscillations (HFOs)

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
University of Cincinnati
Information provided by (Responsible Party):
Jing Xiang, Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT00600717
First received: June 14, 2007
Last updated: July 18, 2017
Last verified: July 2017
June 14, 2007
July 18, 2017
November 1, 2006
July 1, 2020   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00600717 on ClinicalTrials.gov Archive Site
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Clinical Applications of High-Frequency Oscillations
Localizing Functional Brain Cortices and Epileptogenic Zones With HFOs

The objective of this study is to use high-frequency brain signals (HFBS) to localize functional brain areas and to characterize HFBS epilepsy, migraine and other brain disorders. We hope to build the world's first high-frequency MEG/MEG/ECoG/SEEG database for the developing brain. HFBS include high-frequency oscillations (HFOs), ripples, fast ripples or high-gamma activation in the brain.

To reach the goals, we have developed several new MEG methods: (1) accumulated spectrogram; (2) accumulated source imaging; and (3)frequency encoded source imaging.

I. PURPOSE OF STUDY The purpose of this study is to go beyond the conventional analyses of brain signals in a narrow frequency band (typically 1-30 Hz) by measuring brain signals from infraslow to very fast (0.01 - 2800 Hz). Specifically, we propose to study physiological HFOs in sensorimotor, auditory, visual and language evoked magnetic fields and to investigate pathological HFOs in epilepsy, migraine and other disorders. This is clinical very important for many reasons.

For example, There are 400,000 to 600,000 patients with refractory epilepsy in the United States. Since those patients' seizures cannot be controlled by any drugs, epilepsy surgery is one potential cure. Accurate identification of ictogenic zones, the brain areas cause seizures, is essential to ensure a favorable surgical outcome. Unfortunately, the existing method, electrocorticography (ECoG), needs to place electrodes upon the brain surface to capture spikes (typically, 14-70 Hz), which is very risky and costly. The present study is to use magnetoencephalography (MEG) and electroencephalography (EEG) to identification of ictogenic zones noninvasively. To reach the goal, we proposed to detect high frequency (70-2,500 Hz) and low frequency (< 14 Hz) brain signals with advanced signal processing methods. Our central hypothesis is that high frequency brain signals will lead to significantly improved rates of seizure freedom as compared with spikes. This hypothesis is based on recent reports that high frequency brain signals are localized to ictogenic zones.

Building on our unique resources and skills, we plan to address four aims. First, 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. Second, 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 been non-invasively detected by EEG, although the localization of EEG may be significantly inferior to that of MEG. Third, 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 a better seizure outcome. We hypothesize that epilepsy surgery guided by high frequency brain signals detected with MEG/EEG will significantly improve surgical outcomes. Fourth, 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 the 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 improve epilepsy surgery outcomes. According to our pilot data that localization of epileptogenic zones with MEG high frequency signals can increase about 30-40% post-operative seizure freedom, the proposed study should result in millions of intractable epilepsy patients being seizure free. This study also lays a foundation for using low and high frequency brain signals as new biomarkers for diagnosis and treatment of many other disorders (e.g. migraine, autism).

Observational
Observational Model: Other
Time Perspective: Prospective
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Probability Sample
Since this study focuses on normal MEG data, only normal subjects will be studied. Since women, girls, and minorities are included in the population to whom recruiting materials are directed, we anticipate that subject selection will be equitable.
Healthy
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Pediatric Patients and Healthy Children
Healthy children without dental works. Pediatric patients with epilepsy and migraine (headache).

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
120
July 1, 2022
July 1, 2020   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy and cooperative
  • Ages 6-18 (male or female)
  • Normal hearing and vision
  • Normal hand movement
  • No history for neurological or psychiatric disease
  • No family history for genetic neurological or psychiatric diseases.
  • No metal implants such as pacemaker, neuron-stimulator, cochlear device, etc.

Exclusion Criteria:

  • If you are taking any medications for depression, neurologic, or psychiatric condition
  • If you do not feel well, have epilepsy or other brain disorders
  • If you have had a recent concussion or head injury
  • If you have any metal, such as dental braces, in your body that would cause "magnetic noise", you may not be able to be in this study. If you would like, we can do a simple, quick "magnetic noise screening" in the MEG Center, which can tell us whether you can be in the study.
  • If you have any electrical or metal implants such as pacemakers, neuro-stimulators, or orthopedic pins or plates. The research nurse will discuss all exclusions with you in further detail before the magnetic resonance imaging (MRI) scan.
  • If you could not pass the pre-experimental screening
Sexes Eligible for Study: All
6 Years to 18 Years   (Child, Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00600717
IRB 06-04-23
2008-1439 ( Other Identifier: CCHMC )
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Undecided
Jing Xiang, Children's Hospital Medical Center, Cincinnati
Children's Hospital Medical Center, Cincinnati
University of Cincinnati
Study Director: Jing Xiang, Ph.D M.D. Children's Hospital Medical Center, Cincinnati
Children's Hospital Medical Center, Cincinnati
July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP