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Active, Not Recruiting

NCT Number: NCT03629743

Correlate of Surface Electroencephalogram (EEG) With Implanted EEG Recordings (ECOG)

Improve understanding of the correlation between surface EEG and implanted EEG recordings

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Stanford University

Stanford, California, 94305, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or Female subjects 18 years of age or older.
  • English or Spanish Speaking
  • Subjects who have been previously diagnosed with intractable epilepsy and require implantation of invasive electrophysiological recordings as part of their routine clinical presurgical workup.

Exclusion criteria

  • Patients with skin abnormalities at the planned application sites that would interfere with sensor or electrode applications.
  • Patients with pre-existing conditions and/or co-morbidities that would prohibit them from participating in the study due to unacceptable risks to their health and well-being, as determined by the Principal Investigator (PI).
  • Patients who the PI deems ineligible at the PI's discretion
  • Pregnant patients

Treatment and study plan

EEG

Device

EEG will be collected with Brain Product's VAMP-16 channel EEG Monitor using the accompanying software. (Website with further specifications and product details: https://www.brainproducts.com/productdetails.php?id=15)

ECOG

Device

ECOG will be collected with Nihon Kohden acquisition System and accompanying software and depth electrodes.

Primary outcomes

  1. Electrocardiogram (EEG) change before, during, and after anesthesia.

    Time frame: Up to 48 hours. Specific time points are dependent on patient clinical events.

    Patient subjective level of consciousness during and after anesthesia administration will be assessed using response to verbal stimuli, response via button press, reported subjective level of consciousness, and/or response to memory tests (i.e. demonstration of explicit memory recall). Around loss and recovery of consciousness time points (e.g. induction or emergence from anesthesia or when patient falls asleep or wakes up during 24 hour postoperative time points) level of consciousness will be assessed in brief intervals (seconds) until patient no longer responds or begins to respond. Data collected before, after, and during seizure activity if a patient loses consciousness or has diminished consciousness may also be compared.

Secondary outcomes

  1. Electrocardiogram (EEG) change during any changes in consciousness.

    Time frame: Up to 48 hours. Specific time points are dependent on patient clinical events.

    Scalp and cortical electrical activity collected using EEG and ECOG arrays respectively will be analyzed using standard frequency-derived measures (e.g. spectrograms, Fourier analysis), nonlinear dynamical analyses (e.g. correlation dimension, entropy), network dynamics (e.g. connectivity matrices, path length), and/or machine learning. These measures will include all of the data collected from the start of the implant procedure until 24 hours after the implant procedure has ended. Data collected before, after, and during seizure activity if a patient loses consciousness or has diminished consciousness may also be compared. Reports will included characterization of electrophysiological activity before, during, and after variations in behavioral and subjectively reported consciousness.

  2. Electrocardiogram (EEG) change during any seizures.

    Time frame: Up to 48 hours. Specific time points are dependent on patient clinical events.

    Scalp and cortical electrical activity collected using EEG and ECOG arrays respectively will be analyzed using standard frequency-derived measures (e.g. spectrograms, Fourier analysis), nonlinear dynamical analyses (e.g. correlation dimension, entropy), network dynamics (e.g. connectivity matrices, path length), and/or machine learning. Data collected before, after, and during seizure activity if a patient loses consciousness or has diminished consciousness may also be compared. Reports will include characterization and comparison of EEG and ECOG electrophysiological activity and analyses during consciousness transitions and significant time points.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Aug 14, 2018
Registry last updated
Aug 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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