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

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:

• Diagnosis of Dementia, of the following subtypes,

‣ Alzheimer's dementia, according to NIA-AA Criteria for dementia

⁃ Vascular dementia based on:

• i. History consistent with insidious onset of illness and gradual clinical decline ii. MRI evidence of microvascular ischemic disease (microinfarcts) iii. Physical and neurological examination do not indicate current or prior stroke c. Frontotemporal dementia d. Dementia with Lewy Bodies

• Mini Mental Status Exam (MMSE) less than or equal to 15

• Cohen-Mansfield Agitation Inventory Nursing Home Version (CMAI) score of 5 or more on at least one item or score of 4 on two items of aggression or physical nonaggression that holds potentially dangerous consequences including hitting (including self), kicking, grabbing onto people, pushing, throwing things, biting, scratching, spitting, hurting self or other, tearing things or destroying property, making physical sexual advances, trying to get to a different place, or intentional falling (items 1-11, 14, 15) OR one score of 5 or more in items of verbal aggression including screaming, making verbal sexual advances, and cursing or verbal aggression (items 22-24).

• At least one failed pharmacological intervention to manage behavioral symptoms

• Medically stable for safe administration of ECT verified by standard physical examination, urinalysis and serum chemistries and brain imaging when clinically indicated

• Comprehension of English language

• Authorized legal representative able and willing to give informed consent

• Age 40 and above

Locations
United States
Georgia
Emory Healthcare
RECRUITING
Atlanta
Massachusetts
McLean Hospital
RECRUITING
Belmont
Michigan
Pine Rest Christian Mental Health Services
RECRUITING
Grand Rapids
Minnesota
Mayo Clinic
RECRUITING
Rochester
New York
Northwell Health
RECRUITING
Glen Oaks
Contact Information
Primary
Jefferson Mattingly, BA
jmattingly@mclean.harvard.edu
617-855-3168
Backup
Sarah Howie, BS
showie1@mgb.org
617-855-3168
Time Frame
Start Date: 2021-01-28
Estimated Completion Date: 2025-05-31
Participants
Target number of participants: 50
Treatments
Experimental: ECT+UC group
ECT with Usual Care
Sponsors
Collaborators: Mayo Clinic, Pine Rest Christian Mental Health Services, Medical University of South Carolina, Emory University, The Zucker Hillside Hospital
Leads: Brent Forester

This content was sourced from clinicaltrials.gov