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

NCT03629743 | Active Not Recruiting FDA Device

• 1 other identifier: 45987
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

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

  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.

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

Secondary Outcomes (2)

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

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

• Electrocardiogram (EEG) change during any seizures.

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

Study Arms (1)

ECOG and EEG Sensor

Study subjects are neurosurgical patients with medically refractory epilepsy who will have implanted with intracranial ECoG electrodes. The electrodes will be used during a period of inpatient monitoring to identify resectable seizure foci.

Device: EEG; Device: ECOG

Interventions

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 and EEG Sensor

ECOG DEVICE

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

ECOG and EEG Sensor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Stanford Health Care and Clinics

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Related Publications (7)

• Hashiguchi K, Morioka T, Yoshida F, Miyagi Y, Nagata S, Sakata A, Sasaki T. Correlation between scalp-recorded electroencephalographic and electrocorticographic activities during ictal period. Seizure. 2007 Apr;16(3):238-47. doi: 10.1016/j.seizure.2006.12.010. Epub 2007 Jan 19.

  PMID: 17236792 BACKGROUND

• Asano E, Brown EC, Juhasz C. How to establish causality in epilepsy surgery. Brain Dev. 2013 Sep;35(8):706-20. doi: 10.1016/j.braindev.2013.04.004. Epub 2013 May 15.

  PMID: 23684007 BACKGROUND

• Smith EH, Liou JY, Davis TS, Merricks EM, Kellis SS, Weiss SA, Greger B, House PA, McKhann GM 2nd, Goodman RR, Emerson RG, Bateman LM, Trevelyan AJ, Schevon CA. The ictal wavefront is the spatiotemporal source of discharges during spontaneous human seizures. Nat Commun. 2016 Mar 29;7:11098. doi: 10.1038/ncomms11098.

  PMID: 27020798 BACKGROUND

• Ramantani G, Maillard L, Koessler L. Correlation of invasive EEG and scalp EEG. Seizure. 2016 Oct;41:196-200. doi: 10.1016/j.seizure.2016.05.018. Epub 2016 Jun 10.

  PMID: 27324839 BACKGROUND

• Hajat Z, Ahmad N, Andrzejowski J. The role and limitations of EEG-based depth of anaesthesia monitoring in theatres and intensive care. Anaesthesia. 2017 Jan;72 Suppl 1:38-47. doi: 10.1111/anae.13739.

  PMID: 28044337 BACKGROUND

• Fahy BG, Chau DF. The Technology of Processed Electroencephalogram Monitoring Devices for Assessment of Depth of Anesthesia. Anesth Analg. 2018 Jan;126(1):111-117. doi: 10.1213/ANE.0000000000002331.

  PMID: 28786839 BACKGROUND

• Purdon PL, Sampson A, Pavone KJ, Brown EN. Clinical Electroencephalography for Anesthesiologists: Part I: Background and Basic Signatures. Anesthesiology. 2015 Oct;123(4):937-60. doi: 10.1097/ALN.0000000000000841.

  PMID: 26275092 BACKGROUND

MeSH Terms

Interventions

Electroencephalography

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Officials

• David Drover, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: May 29, 2018
• First Posted: August 14, 2018
• Study Start: November 11, 2019
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)