Electroconvulsive Therapy (ECT) for Agitation in Dementia (AD) (ECT-AD)
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03926520|
Recruitment Status : Recruiting
First Posted : April 24, 2019
Last Update Posted : June 15, 2022
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer Dementia Agitation,Psychomotor||Device: Electroconvulsive Therapy (ECT) Other: Simulated Electroconvulsive Therapy (S-ECT)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Care Provider, Investigator)|
|Official Title:||A Randomized Controlled Trial of Electroconvulsive Therapy Plus Usual Care Versus Simulated-ECT Plus Usual Care for the Acute Management of Severe Agitation in Dementia|
|Actual Study Start Date :||January 28, 2021|
|Estimated Primary Completion Date :||March 2024|
|Estimated Study Completion Date :||March 2024|
|Experimental: ECT+UC group||
Device: Electroconvulsive Therapy (ECT)
Stimulus method of delivery will be RUL electrode placement, and ultra-brief (UB) pulse width (0.25-0.37ms). At the first ECT session, seizure threshold (ST) will be determined by titration with the empirical dose titration method and subsequent treatments will be approximately 6 times the ST. Following other NIMH sponsored multicenter ECT studies (PRIDE, U01 MH055495), stimulus settings will be adjusted as needed during the ECT course based on seizure quality and treatment efficacy. Participants will be administered anesthesia.
|Sham Comparator: S-ECT+UC group||
Other: Simulated Electroconvulsive Therapy (S-ECT)
The participant is brought to the ECT suite for the length a session would normally take (approximately 2 hours). While in the ECT suite, conducting gel will be placed on the scalp of the S-ECT subjects to parallel the ECT procedures in the ECT active group. An IV will be placed to provide PRN medication and fluids as needed. IV placement will also provide a method for study staff to assess physical interference and subject resistance to treatment. Participants will not be administered anesthesia.
- CMAI total score [ Time Frame: The CMAI will be collected through study completion, about 13 months ]The CMAI measures the efficacy of ECT+UC in reducing severe agitation in AD subjects than S-ECT. The CMAI is a 29-item scale with each item ranging from 1-7 in frequency with 7 being the highest and therefore worst outcome.
- Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change Scale (ADCS-CGIC) [ Time Frame: The ADCS-CGIC will be collected for one month ]The ADCS-CGIC gives a discrete score that ranges from 1-7 with 7 being the worst outcome.
- Neuropsychiatric Inventory, Clinician Version (NPI-C) [ Time Frame: The NPI-C will be collected for one month ]The NPI-C is an improved version of the NPI composed of several domains of which we will use Agitation and Aggression, as well as their sum. The higher the frequency and/or severity within each domain, the worse the condition of the patient.
- Pittsburgh Agitation Scale (PAS) [ Time Frame: The PAS will be collected for one month ]The PAS assesses four behavioral domains. Each domain has an intensity score ranging from 0-4 with 4 being the worst outcome.
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): NCT03926520
|Contact: Jefferson Mattingly, BAfirstname.lastname@example.org|
|Contact: Maria DelPico, BSemail@example.com|
|United States, Georgia|
|Atlanta, Georgia, United States, 30308|
|Contact: Valeriya Tsygankova firstname.lastname@example.org|
|Principal Investigator: Adriana Hermida, MD|
|United States, Massachusetts|
|Belmont, Massachusetts, United States, 02478|
|Contact: Jefferson Mattingly, BA email@example.com|
|Principal Investigator: Brent P Forester, MD, MSc|
|United States, Michigan|
|Pine Rest Christian Mental Health Services||Recruiting|
|Grand Rapids, Michigan, United States, 49548|
|Contact: Olivia Holzgen Olivia.Holzgen@pinerest.org|
|Principal Investigator: Louis Nykamp, MD|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Contact: Sarah Williams Williams.Sarah2@mayo.edu|
|Principal Investigator: Maria I Lapid, MD|
|United States, New York|
|Glen Oaks, New York, United States, 11004|
|Contact: Heela Azizi firstname.lastname@example.org|
|Principal Investigator: Georgios Petrides, MD|
|Principal Investigator:||Brent P Forester, MD, MSc||Mclean Hospital|
|Principal Investigator:||George Petrides, MD||Northwell Health|