Clinical trial NCT03629743: Correlate of Surface Electroencephalogram (EEG) With Implanted EEG Recordings (ECOG)
Official title: Correlate of Surface Electroencephalogram (EEG) With Implanted EEG Recordings (ECOG)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Anesthesia
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2018-08-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stanford Health Care and Clinics

Brief summary: Improve understanding of the correlation between surface EEG and implanted EEG recordings


Eligibility criteria: 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

Primary outcomes:
measure: Electrocardiogram (EEG) change before, during, and after anesthesia.
timeFrame: Up to 48 hours. Specific time points are dependent on patient clinical events.
Secondary outcomes:
measure: Electrocardiogram (EEG) change during any changes in consciousness.
timeFrame: Up to 48 hours. Specific time points are dependent on patient clinical events.
measure: Electrocardiogram (EEG) change during any seizures.
timeFrame: Up to 48 hours. Specific time points are dependent on patient clinical events.
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: David Drover, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.