Brain Dynamics in Different Stages of Arousal and Anesthesia (ECOG)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01574443|
Recruitment Status : Terminated (Feasibility issues for subject recruitment and PI left the institution)
First Posted : April 10, 2012
Last Update Posted : November 6, 2017
|Condition or disease|
- Once the electrode array is placed during the first surgery (on the day of admission) we will record brain activity as subjects are waking up from anesthesia
- While subjects are staying at New York Presbyterian hospital before the second surgery we will record brain activity. Most of the recordings will be performed as subjects are going to sleep naturally, but other recordings will be acquired during waking hours. This will not interfere with normal monitoring of seizure activity.
- Final recording session is immediately before the second operation as general anesthesia is gradually induced. During this time subjects may be asked to follow simple commands like: "Open your eyes" in order to determine the level of consciousness. Also during this session, if arterial line is placed by the anesthesiologist for real-time blood pressure monitoring we will collect several small (~1 ml) blood samples to determine blood concentration of anesthetics. Approximately 1 teaspoon of blood will be obtained in total. No additional venipuncture will be necessary.
No additional invasive procedures will be performed for the purposes of the study. We will use the same electrode array as is typically used for monitoring and mapping of epilepsy. Subjects will receive the same anesthetic agent as is commonly used for induction of anesthesia for this surgery (propofol). Subjects will be monitored in the same way as is normally done during surgical procedures and during your stay at New York Presbyterian hospital.
As a part of the study subjects may be asked simple questions as they go under anesthesia.
We may collect several small blood samples (described above) to determine the concentration of anesthetic agents.
|Study Type :||Observational|
|Actual Enrollment :||5 participants|
|Official Title:||Brain Dynamics in Different Stages of Arousal and Anesthesia|
|Actual Study Start Date :||August 22, 2011|
|Actual Primary Completion Date :||May 11, 2015|
|Actual Study Completion Date :||April 8, 2016|
epilepsy resection patients
Patients undergoing resection for refractory epilepsy
- Characterization of changes in brain dynamics during induction of anesthesia, using electrocorticography (ECoG). [ Time Frame: < 1 hour ]The patterns of electrical activity during induction and emergence from anesthesia will be compared to what is recorded during natural sleep.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01574443
|United States, New York|
|New York Presbyterian Hospital/ Weill Cornell Medical College|
|New York, New York, United States, 10065|
|Principal Investigator:||Kane Pryor, MD||Weill Medical College of Cornell University|