RecruitingNot ApplicableNCT03926520

Electroconvulsive Therapy (ECT) for Agitation in Dementia (AD)

Effect and Safety of Electroconvulsive Therapy Plus Usual Care for the Acute Management of Severe Agitation in Dementia


Sponsor

Brent Forester

Enrollment

50 participants

Start Date

Jan 28, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

This study will explore the effect of ECT treatments plus usual care (ECT+UC) in reducing severe agitation in patients with moderate to severe dementia including Alzheimer's Disease, Vascular dementia, Frontotemporal dementia, and Dementia with Lewy Bodies. The study will also determine the tolerability/safety outcomes of ECT+UC.


Eligibility

Min Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether electroconvulsive therapy (ECT) — brief, controlled electrical stimulation of the brain under anesthesia — can safely and effectively reduce severe agitation in people with dementia who have not responded to medications. **You may be eligible if...** - You have a confirmed diagnosis of Alzheimer's, vascular, frontotemporal, or Lewy body dementia - Your cognitive score is 15 or below on a standard test (indicating moderate to severe dementia) - You are experiencing severe agitation (such as hitting or kicking) that disrupts care and has not responded to other approaches **You may NOT be eligible if...** - You have had a recent heart attack or brain bleeding - You have conditions that make anesthesia unsafe - You are on medications incompatible with ECT Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEElectroconvulsive 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.


Locations(5)

Emory Healthcare

Atlanta, Georgia, United States

McLean Hospital

Belmont, Massachusetts, United States

Pine Rest Christian Mental Health Services

Grand Rapids, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

Northwell Health

Glen Oaks, New York, United States

View Full Details on ClinicalTrials.gov

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NCT03926520


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