The Effect on Cognition of Terminating ECT Induced Seizures With Propofol
|ClinicalTrials.gov Identifier: NCT00616759|
Recruitment Status : Completed
First Posted : February 15, 2008
Results First Posted : February 4, 2013
Last Update Posted : October 25, 2017
|First Submitted Date ICMJE||February 4, 2008|
|First Posted Date ICMJE||February 15, 2008|
|Results First Submitted Date||November 30, 2010|
|Results First Posted Date||February 4, 2013|
|Last Update Posted Date||October 25, 2017|
|Study Start Date ICMJE||September 2006|
|Actual Primary Completion Date||September 2008 (Final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
||Wechsler Memory Scale-III (WMS-III) Auditory Delayed Index [ Time Frame: Pre-tesing within 36 hours before first ECT; Post-testing within 36 hours of 6th ECT. ]
WMS-III Auditory Delayed Index is a measure of memory functioning. The results given are the post-ECT testing results. A smaller number indicates less memory disturbance on this scale. The range of scores is between 0-140 with higher scores indicating better memory function.
|Original Primary Outcome Measures ICMJE
||Wechsler Memory Scale-III [ Time Frame: Within one week Pre-ECT and within 48 hours after the 6th ECT ]|
|Change History||Complete list of historical versions of study NCT00616759 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||California Verbal Learning Test (CVLT) [ Time Frame: Within one week pre-ECT and within 48 hours after the 6th ECT ]
CVLT consists of a number of individual subtests of various aspects of memory. Higher scores indicate better memory function.
|Original Secondary Outcome Measures ICMJE
||California Verbal Learning Test [ Time Frame: Within one week pre-ECT and within 48 hours after the 6th ECT ]|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||The Effect on Cognition of Terminating ECT Induced Seizures With Propofol|
|Official Title ICMJE||The Effect on Cognition of Terminating ECT Induced Seizures With Propofol|
|Brief Summary||Participating subjects are those who are referred for electroconvulsive therapy (ECT) for severe depression who have agreed to the protocol. The control group receives ECT as usual. The other group receives propofol to terminate the ECT-induced seizure timed so that the seizure lasts at least 25 seconds. Extensive neuropsychological testing is being done on both groups before beginning ECT and within 48 hours after the 6th treatment. Multiple markers of the rapidity of recovery from anesthesia are being obtained from all subjects for 6 ECTs.|
ECT Administration All patients will receive ECT administered using a Thymatron-System IV (Somatics, LLC , Lake Bluff, IL) ECT device, the same device used for our usual ECT. All patients will be monitored with continuous electrocardiogram (EKG) monitoring, pulse oximetry, and regular blood pressure readings from an automatic inflatable cuff on one arm. Seizure threshold will be determined at the first treatment. The subsequent treatment will be administered at 1.5 times the seizure threshold. Stimulus dose will be increased as necessary to produce a seizure of at least 20 seconds observed duration of motor activity. All patients whose seizure duration is less than 20 seconds of motor activity will be re-stimulated at the same treatment session at a 50% increase in stimulus intensity unless this occurred at the maximum stimulus charge available. All monitoring described and the titration process is part of our normal ECT routine. Electrode placement will be bilateral for all patients which is the predominate placement used for our usual patients. Patients in the standard group will receive ECT as described elsewhere (Abrams, 2001). Patients in the experimental group will receive ECT as the other group. However, approximately 15 seconds after stimulus delivery they will receive a 1 mg/kg dose of propofol intravenously in order to terminate brain seizure activity reliably, whether evident on surface EEG or not. In view of 30-60 second circulation time this will limit seizure duration to 45-75 sec, and generally to the same duration at each session because the circulation time is an individual characteristic.
Routine anesthetic agents will include hyperventilation with 100% oxygen by mask, and initial dosages of succinylcholine 1 mg/kg IV, and etomidate 0.2 mg/kg IV, adjusted as needed over the treatment course. Atropine 0.4-1.0 mg will also be given intravenously before the anesthetic agent. Blood pressure and pulse will be assessed prior to treatment and 1 minute, 3 minutes, and 5 minutes following the ECT stimulus and periodically thereafter. All patients will receive at least 6 index ECT. Those needing additional treatment will receive standard ECT. Propofol and etomidate are used for our normal ECT treatments as well as atropine and succinylcholine. Blood pressure monitoring is also a part of routine ECT.
Electroencephalogram (EEG) Recording and Computer EEG Analysis Four channels of EEG data will be recorded using bilateral frontal-mastoid and bilateral frontal-occipital electrodes. Frontal and mastoid recording electrodes used will be EEG/EMG/ECG Adherent Recording Electrodes. (Somatics, LLC.) Occipital electrodes used will be Grass 10mm gold electrode. Preparation of the occipital area may include using Lemon Prep Skin Prep (Mavidon Medical LP-0019), Elefix conductive paste (Niho Kohden America, Inc.). Nu Prep Cover Roll stretch (BSN Medical) will be cut to facilitate the covering of electrodes. Analysis of some parameters of each seizure will be done with software provided by the manufacturer of the Thymatron system IV. Our standard ECT includes 2 channels of EEG recording using bilateral fronto-mastoid electrode placement using Adherent Recording Electrodes (Somatics, LLC) with computer analysis of channel 1.
Cognitive Assessment Cognition will be assessed using neuropsychological battery subtests which measure difficulties of retention of newly learned material (anterograde amnesia) and past events (retrograde amnesia) such as the California Verbal Learning Test (CVLT)(subtests: recognition tests A & B and long delay free recall). Wechsler Memory Scale (WMS III)(subtests: Mental Control, Logical Memory recognition, Memory Span), Trail Making A & B, Rey Auditory Verbal learning Test, and Rey Osterrieth Complex Figure Test (copy, recall and recognition trials). In addition, Hamilton Rating Scale of Depression, Clinical Global Improvement (CGI), Modified Mini Mental Status (3MSE), Autobiographical memory interview, Beck Depression Index (BDI) will be performed.
Emergence from anesthesia will be determined by measuring post-treatment reorientation time such as time to awaken, name recall, orientation to location, date and day of the week, with the time beginning at the end of stimulus application. Following awakening, patients will be asked at 1-min intervals to open their eyes and to squeeze the investigator's hand. The time from stimulation as well as the time from when the patients open their eyes to performance of the appropriate response to both commands will be noted. The same procedure will be used to identify place and date at 1-min intervals until the correct answer is given for each question. As soon as orientation occurs, we will administer a series of tests to evaluate recovery of psychomotor function, including the Trieger test (volunteers are asked to connect a series of dots), P-deletion test (volunteers are asked to select all letters "p" in a text of random letters during 180 s), and the Digit Symbol Substitution test (volunteers are asked to match numbers and symbols during 90 s) 15, 30, 45, 60, 75, and 90 min after cessation of anesthesia. These tests have been used previously to study recovery from anesthesia. At the same times patients will be asked to evaluate their "sense of clear-headedness," and "sense of energy". All assessments will be carried out by a blind investigator to the group membership of the patient. Our standard ECT utilizes the Mini Mental Status Examination before every third ECT to measure cognitive change. Cognitive testing emerging from anesthesia is not routinely done.
All subjects will receive six individual treatment sessions given 3 days per week. Investigators will be aware of the treatment parameters; however, independent raters will be blinded as to which treatment was administered.
Prior to the experimental treatment sessions, all subjects will participate in several preliminary meetings with the MD investigator and the psychologist. Each session will be used to facilitate the psychiatric screening, lab tests, psychological and neuropsychological tests in order to establish a baseline of memory functioning.
The experimental treatment sessions themselves will be supervised and facilitated by the MD investigator following the guidelines previously developed for this experimental procedure. Except for the administration of propofol or no drug at all following the administration of ECT, the treatment protocols will be exactly the same for each treatment group.
|Study Type ICMJE||Interventional|
|Study Phase||Not Applicable|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
|Condition ICMJE||Major Depression|
|Publications *||Warnell RL, Swartz CM, Thomson A. Propofol interruption of ECT seizure to reduce side-effects: a pilot study. Psychiatry Res. 2010 Jan 30;175(1-2):184-5. doi: 10.1016/j.psychres.2009.08.019. Epub 2009 Nov 5.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Actual Enrollment ICMJE
|Original Estimated Enrollment ICMJE||Same as current|
|Actual Study Completion Date||September 2008|
|Actual Primary Completion Date||September 2008 (Final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
|Ages||45 Years and older (Adult, Older Adult)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00616759|
|Other Study ID Numbers ICMJE||56164|
|Has Data Monitoring Committee||No|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Loma Linda University|
|Study Sponsor ICMJE||Loma Linda University|
|Collaborators ICMJE||Not Provided|
|PRS Account||Loma Linda University|
|Verification Date||October 2017|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP