Study Results
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Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2023-09-14
2028-01-01
Brief Summary
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H1: Individualized amplitude arm will have improved RUL antidepressant outcome (IDS-C30 response rates and reduced BT electrode placement switch at V2).
H2: Individualized amplitude arm will have improved cognitive outcomes (DKEFS-Verbal Fluency
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Detailed Description
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Subjects will receive baseline imaging, clinical (primary outcome: clinician rated Inventory of Depressive Symptomatology, IDS-C30), and neuropsychological assessment (primary outcome: Delis Kaplan Executive Function System Verbal Fluency, DKEFS) 24 to 48 hours prior to the first ECT session (V1). Subjects will receive their second assessment (V2) one day after the sixth ECT treatment and the final assessment (V3) one day after the ECT series. If the subject fails to demonstrate improvement at V2 (\< 25% reduction from baseline IDS-C30 total score, the primary antidepressant outcome), the subject will then receive bitemporal (BT) electrode placement for the remainder of the ECT series. The transition to BT will be a secondary antidepressant outcome. Subjects will be randomized to receive right unilateral (RUL) electrode placement with an individualized amplitude (n = 25) or traditional fixed 800 mA amplitude (n = 25, 1:1 ratio). Subjects and Raters will be blinded to subject assignment. Subjects in both arms will receive fixed pulse width (1.0 milliseconds), frequency (20 hertz), and pulse train duration (8 seconds).
For the individualized amplitude arm, subjects will receive RUL amplitude determined seizure titration during the first treatment like the R61 phase of the investigation (IDE for Soterix adapter: G200123). Subsequent RUL treatments will be completed with an individualized amplitude. To determine the individualized amplitude, we will use Ebrain. The individualized amplitude can be determined from the optimal E-field (V/m) / baseline E-field (V/m per mA). If a discrepancy exists between the amplitude seizure and E-field modeling methods that results in amplitude difference \> 100 mA, we will use the E-field modeling method to determine the individualized amplitude. We will round the amplitude to the nearest 100 mA from 500 to 900 mA (the current dosing range of the FDA approved ECT device).
For the fixed 800 mA amplitude arm, subjects will receive RUL amplitude determined seizure titration during the first treatment. The rationale for amplitude titration with the fixed amplitude arm is to 1) improve the goodness of fit of the amplitude-seizure and Ebrain relationship; and 2) control for a sub-therapeutic stimulation associated with the first treatment for both arms. RUL amplitude seizure titration will be conducted during the first treatment like the individualized amplitude arm. Subsequent RUL treatments will be completed with 800 mA amplitude. The only difference between the arms will be individualized versus fixed 800 mA amplitude after amplitude titration.
A randomized controlled trial will compare hippocampal neuroplasticity, antidepressant, and cognitive outcomes between individualized amplitude and fixed 800 mA amplitude ECT in older depressed subjects (n = 25 per group, n = 50 total). Relative to fixed 800 mA ECT:
H1: Individualized amplitude arm will have improved RUL antidepressant outcome (IDS-C30 response rates and reduced BT electrode placement switch at V2).
H2: Individualized amplitude arm will have improved cognitive outcomes (DKEFS-Verbal Fluency
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Variable amplitude
Individualized amplitude
Soterix Medical Incorporated 4x1 adapter
Device permits individualized amplitudes
Fixed amplitude
Fixed (800 milliamperes) amplitude
Traditional ECT device
FDA approved ECT device with fixed amplitude.
Interventions
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Soterix Medical Incorporated 4x1 adapter
Device permits individualized amplitudes
Traditional ECT device
FDA approved ECT device with fixed amplitude.
Eligibility Criteria
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Inclusion Criteria
* Clinical indications for ECT with right unilateral electrode placement
Exclusion Criteria
* Other psychiatric conditions (e.g., schizophrenia, bipolar I disorder)
* Current drug or alcohol use disorder (except for nicotine)
* Contraindications to MRI.
50 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
University of New Mexico
OTHER
Responsible Party
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Principal Investigators
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Chris Abbott, MD
Role: PRINCIPAL_INVESTIGATOR
University of New Mexico
Locations
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University of New Mexico Health Science Center
Albuquerque, New Mexico, 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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