Electroconvulsive Therapy (ECT) for Agitation in Dementia (AD)
NCT ID: NCT03926520
Last Updated: 2024-06-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2021-01-28
2025-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ECT+UC group
ECT with Usual Care
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
1. Alzheimer's dementia, according to NIA-AA Criteria for dementia
2. 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
2. Mini Mental Status Exam (MMSE) less than or equal to 15
3. 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).
4. At least one failed pharmacological intervention to manage behavioral symptoms
5. Medically stable for safe administration of ECT verified by standard physical examination, urinalysis and serum chemistries and brain imaging when clinically indicated
6. Comprehension of English language
7. Authorized legal representative able and willing to give informed consent
8. Age 40 and above
Exclusion Criteria
2. Diagnosis of vascular dementia due to stroke, based on:
* History consistent with abrupt onset and step-wise progression of cognitive and functional decline
* MRI scan within the past 12 months demonstrating evidence of hemorrhagic and embolic stroke
* Physical and neurologic examination consistent with current or prior stroke
3. Lifetime or current diagnosis of Schizophrenia, Bipolar Disorder or Schizoaffective Disorder
4. Active substance use disorder within past 6 months
5. Treatment with ECT or other neurostimulation therapies (e.g., TMS or vagal nerve stimulation) within the past 3 months
40 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Pine Rest Christian Mental Health Services
OTHER
Emory University
OTHER
The Zucker Hillside Hospital
OTHER
Medical University of South Carolina
OTHER
Brent Forester
OTHER
Responsible Party
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Brent Forester
Principal Investigator
Principal Investigators
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Brent P Forester, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
Mclean Hospital
George Petrides, MD
Role: PRINCIPAL_INVESTIGATOR
Northwell Health
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2020P002276
Identifier Type: -
Identifier Source: org_study_id
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