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

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Brent Forester
Study ID
NCT03926520
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Electroconvulsive Therapy (ECT) — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Jan 28, 2021
Status verified
Apr 2026
Primary completion
May 31, 2026
Completion
May 31, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: ECT+UC group
    ECT with Usual Care

Primary Outcome Measure

CMAI total score [ Time Frame: The CMAI will be collected through study completion, about 13 months ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Emory HealthcareAtlantaGeorgia30308
Valeriya Tsygankova
[email protected]
Adriana Hermida, MD (PRINCIPAL_INVESTIGATOR)
McLean HospitalBelmontMassachusetts02478
Jefferson Mattingly, BA
[email protected]
Brent P Forester, MD, MSc (PRINCIPAL_INVESTIGATOR)
Pine Rest Christian Mental Health ServicesGrand RapidsMichigan49548
Olivia Holzgen
[email protected]
Louis Nykamp, MD (PRINCIPAL_INVESTIGATOR)
Mayo ClinicRochesterMinnesota55905
Sarah Williams
[email protected]
Maria I Lapid, MD (PRINCIPAL_INVESTIGATOR)
Northwell HealthGlen OaksNew York11004
Georgios Petrides, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Atlanta, GA

By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
Emory Healthcare· Atlanta, GAMcLean Hospital· Belmont, MAPine Rest Christian Mental Health Services· Grand Rapids, MIMayo Clinic· Rochester, MNNorthwell Health· Glen Oaks, NY

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