RECRUITING

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

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Conditions

Alzheimer DementiaAgitation,PsychomotorECTAgitationAlzheimer'sDementia

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-01-28
Study Completion:2025-05-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03926520

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. 1. Current diagnosis of co-morbid delirium, measured by the Confusion Assessment Measure (CAM) and by clinical diagnosis
  2. 2. Diagnosis of vascular dementia due to stroke, based on:
  3. * History consistent with abrupt onset and step-wise progression of cognitive and functional decline
  4. * MRI scan within the past 12 months demonstrating evidence of hemorrhagic and embolic stroke
  5. * Physical and neurologic examination consistent with current or prior stroke
  6. 3. Lifetime or current diagnosis of Schizophrenia, Bipolar Disorder or Schizoaffective Disorder
  7. 4. Active substance use disorder within past 6 months
  8. 5. Treatment with ECT or other neurostimulation therapies (e.g., TMS or vagal nerve stimulation) within the past 3 months

Contacts and Locations

Study Contact

Jefferson Mattingly, BA
CONTACT
617-855-3168
jmattingly@mclean.harvard.edu
Sarah Howie, BS
CONTACT
617-855-3168
showie1@mgb.org

Principal Investigator

Brent P Forester, MD, MSc
PRINCIPAL_INVESTIGATOR
Mclean Hospital
George Petrides, MD
PRINCIPAL_INVESTIGATOR
Northwell Health

Study Locations (Sites)

Emory Healthcare
Atlanta, Georgia, 30308
United States
McLean Hospital
Belmont, Massachusetts, 02478
United States
Pine Rest Christian Mental Health Services
Grand Rapids, Michigan, 49548
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
Northwell Health
Glen Oaks, New York, 11004
United States

Collaborators and Investigators

Sponsor: Brent Forester

  • Brent P Forester, MD, MSc, PRINCIPAL_INVESTIGATOR, Mclean Hospital
  • George Petrides, MD, PRINCIPAL_INVESTIGATOR, Northwell Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-01-28
Study Completion Date2025-05-31

Study Record Updates

Study Start Date2021-01-28
Study Completion Date2025-05-31

Terms related to this study

Keywords Provided by Researchers

  • ECT
  • Agitation
  • Alzheimer's
  • Dementia

Additional Relevant MeSH Terms

  • Alzheimer Dementia
  • Agitation,Psychomotor