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

Active, not recruiting

• Conditions: Anesthesia
• Interventions: Device: EEG; Device: ECOG

• Registration Number: NCT03629743
• Lead Sponsor: Stanford University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-29
• Study First Submitted QC: 2018-08-12
• Study First Posted: 2018-08-14
• Study Start: 2019-11-11
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-07
• Last Update Posted: 2024-08-09
• Primary Completion: 2025-08-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ECOG and EEG Sensor	EEG	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.
ECOG and EEG Sensor	ECOG	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.

Primary Outcome Measures

Name	Time	Method
Electrocardiogram (EEG) change before, during, and after anesthesia.	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 Outcome Measures

Name	Time	Method
Electrocardiogram (EEG) change during any seizures.	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.
Electrocardiogram (EEG) change during any changes in consciousness.	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.

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States