Ignite Creation Date:
2024-05-06 @ 8:34 AM
Last Modification Date:
2024-10-26 @ 12:01 PM
Study NCT ID:
NCT02761330
Status:
COMPLETED
Last Update Posted:
2021-06-28
First Post:
2016-04-30
Brief Title:
Cognitive Recovery After Electroconvulsive Therapy and General Anesthesia
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
Cognitive Recovery After Electroconvulsive Therapy and General Anesthesia Reconstitution of Consciousness and Cognition Phase 2
Status:
COMPLETED
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RCC2
Brief Summary:
This study is geared toward characterizing the recovery of brain activity and cognitive function following treatments of electroconvulsive therapy and ketamine general anesthesia
Detailed Description:
Seizures are often associated with loss of consciousness possibly through effects on sub-cortical arousal systems disruption of cortical-subcortical interactions and ultimately through depressed neocortical function Furthermore people are often confused in the post-ictal state even when consciousness returns after a seizure Disrupted cognitive function during the postictal phase has not been fully characterized but presents short and long-term implications Many experience an acute disorder of attention consciousness and cognition referred to as delirium Memory deficits are also common The neurobiology for these phenomena are incomplete and challenging to test as seizures are typically sporadic and vary in intensity and character In contrast the setting of electroconvulsive therapy ECT provides the opportunity to study the reconstitution of consciousness and cognition following seizures in an elective and predictable context
There is no standard agent used to induce general anesthesia during ECT Ketamine is receiving greater attention as an infusion for treating depression and for its potential benefits on improving ECT efficacy and expediting cognitive recovery Further data are needed to determine whether ketamine may improve recovery of cognitive function relative to etomidate a commonly used anesthetic for general anesthesia during ECT
The investigators will evaluate the cognition function and electroencephalographic patterns that accompany the recovery from ECT and general anesthesia Twenty patients with refractory depression will be randomized in this interventional single-blinded randomized crossover trial Each patient will complete seven study visits The first visit will be conducted during the dose-charge titration ECT treatment with etomidate anesthesia After this session patients will be randomized to three sessions each week for two weeks six treatments total Over the first week patients will be randomized in order for three treatment arms 1 etomidate general anesthesia and ECT 2 ketamine general anesthesia and ECT and 3 ketamine alone Patients will be blinded to the treatment arm for each session Baseline and post-treatment measurements of cognition and ECT will be acquired on each of the six treatment sessions
Patients that agree will have a MRI
There is no standard agent used to induce general anesthesia during ECT Ketamine is receiving greater attention as an infusion for treating depression and for its potential benefits on improving ECT efficacy and expediting cognitive recovery Further data are needed to determine whether ketamine may improve recovery of cognitive function relative to etomidate a commonly used anesthetic for general anesthesia during ECT
The investigators will evaluate the cognition function and electroencephalographic patterns that accompany the recovery from ECT and general anesthesia Twenty patients with refractory depression will be randomized in this interventional single-blinded randomized crossover trial Each patient will complete seven study visits The first visit will be conducted during the dose-charge titration ECT treatment with etomidate anesthesia After this session patients will be randomized to three sessions each week for two weeks six treatments total Over the first week patients will be randomized in order for three treatment arms 1 etomidate general anesthesia and ECT 2 ketamine general anesthesia and ECT and 3 ketamine alone Patients will be blinded to the treatment arm for each session Baseline and post-treatment measurements of cognition and ECT will be acquired on each of the six treatment sessions
Patients that agree will have a MRI
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None