Protocol
What is the aim of the study?
What is to compare ECT/S-ECT in the treatment of agitation and aggression in Alzheimer's Disease
What does the CAM tell us about ECT?
What is if subject is positive for delirium according to the CAM, ECT treatment will be held for that day, if subject is positive for delirium for 3 consecutive treatments, subject will be discontinued
Is the treating physician unblinded or blinded?
What is unblinded.
Who is Steve Seiner?
What is ECT?
What is electroconvulsive therapy
What dementia diagnoses can we enroll?
What is Alzheimer's, FTD, Lewey Body and Vascular.
What do the SIB-8 and Barthel Index tell us about ECT treatment?
If there is a decline of 6 or greater on the SIB-8 after 3 consecutive ECT treatments or 30 or greater on the Barthel Index, then ECT will not be given
When do we use the SIB-8?
What is ALWAYS
What does an unblinded coordinator do?
What is transfer the subject from the inpatient unit to the ECT suite, fill out eligibility and randomization forms on WebDCU, gives ECT suite randomization form and patient report form, intervention side effect forms, and they does not administer any scales.
How do we define simulated ECT?
What is receiving everything besides anesthesia and shock, they still get an IV and they get glue placed on their scalp and spend the same amount of time in the suite as patients receiving active ECT.
What is the difference in an unanticipated side effect or an adverse event?
What is an unanticipated side effect is an unexpected adverse event. Anticipated side effects such as abnormal EKG, hypertension, hypotension that continues during recovery or after treatment, or if the investigator feels it is warranted to report is an adverse event. Adverse events are worsening of a pre-exisiting condition, clinically significant abnormal lab values, symptoms associated with ECT treatment, or accidental injuries sustained while subject is in the study.
When is ECT stopped for IV placement?
When do we use the Barthel Index?
What is when there is a floor effect on the SIB 8 (score of 5 or less at baseline) or decline of more than 6 points from baseline after 3 consecutive ECT treatment attempts
What does a blinded coordinator do?
What is complete the demographic information and schedule testing (also serves as back up rater).
What are the side effects of ECT?
What are muscle aches, headaches, nausea and vomiting, and difficulty urinating and rare medical complications.
When do you report a side effect as an adverse event?
What is if it an abnormal EKG, hypertension or hypotension if they continue during recovery or after treatment, or if the investigator feels it is warranted to report.
What score on the ADCS-CGIC determines doscontinuation?
What is 7
What scales does the treating physician do?
What is ADCS-GCIC and Bush Francis Catatonia Rating Scale.
What is the role of the blinded rater?
What is complete the MMSE, Zarit, QUALID, Barthel, SIB-8, CAM, FAM-CAM, and PAS.
What is ECT approved to treat?
What is depression, schizophrenia, Parkinson's and catatonia.
Where are the two electrodes placed and when are they switched?
What is Right Unilateral Placement up until 6 ECT treatments when it changes to Bilateral if there is still inadequate clinical response determined by an ADCS-CGIC score of 4-6
When is remission achieved?
What is a CMAI score of less than or equal to 2 on all individual items of the CMAI inclusion criteria for two consecutive assessment periods
What scales does the blinded clinician do?
What is CSDD, NPIC, and CGIS.
Who does the monitoring and what does it entail?
What is Jeff (lab manager). He completes audits of sites 6 months after they enroll a subject either in-person or via zoom.
What has our group proven ECT is effective to treat?
What is naturalistically and retrospectively we have shown that agitation, depression, psychosis and other behavioral disturbances can be treated by ECT.