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Electroconvulsive Therapy Amplitude Titration

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ClinicalTrials.gov Identifier: NCT04621786
Recruitment Status : Recruiting
First Posted : November 9, 2020
Last Update Posted : May 3, 2021
Sponsor:
Collaborators:
The Zucker Hillside Hospital
National Institute of Mental Health (NIMH)
The Mind Research Network
University of Texas Southwestern Medical Center
Information provided by (Responsible Party):
University of New Mexico

Brief Summary:
This study is focused on advancing ECT treatment for older adults with depressive disorders by refining neuromodulation stimulus parameters to improve efficacy and cognitive safety.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Device: Mecta Spectrum 5000Q paired with Soterix Medical 4X1 HD - ECT Multi-Channel Stimulation Interface Not Applicable

Detailed Description:
Amplitude titration, as proposed in this current proposal, can reduce the variability related to fixed amplitude dosing and optimize clinical and cognitive outcomes. The goal of this project is to change standard ECT parameter selection from a fixed amplitude to an individualized and empirically determined amplitude. To achieve this goal, the investigators will focus on the relationship between amplitude titration and treatment-responsive changes in hippocampal neuroplasticity with RUL fixed amplitude ECT. Fixed amplitude ECT results in variable E-field or ECT dose. Over the course of an ECT series, the variable ECT dose will result in inconsistent changes in hippocampal neuroplasticity. In contrast, pre-translational investigations have demonstrated that amplitude titration results in a consistent E-field or ECT "dose". Seizure titration amplitudes (based on historic data, 233 to544mA) are below the amplitude range of FDA-approved ECT devices (500 to 900mA) and will require an adaptor to reduce the output amplitude (Investigational Device Exemption). Amplitude titration will also be below the hippocampal neuroplasticity threshold and insufficient for antidepressant response. The difference between RUL amplitude titration and RUL fixed amplitude (800mA) ECT will determine the degree of target engagement with the hippocampus. To illustrate, subjects with low amplitude titration of ~250 mA (800/250, high fixed/titration amplitude ratio) will have significant changes in hippocampal neuroplasticity. Subjects with high amplitude titration ~500mA (800/500, low fixed/titration ratio) will have minimal changes in hippocampal neuroplasticity. The relationship between amplitude titration and fixed amplitude hippocampal neuroplasticity will be used to develop the amplitude multiplier required for consistent and clinically effective ECT dosing.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Electroconvulsive Therapy Amplitude Titration for Improved Clinical Outcomes in Late Life Depression
Actual Study Start Date : March 1, 2021
Estimated Primary Completion Date : December 1, 2022
Estimated Study Completion Date : December 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental arm
All subjects enrolled will receive amplitude titration for their first treatment. The remainder of the ECT series will be completed with traditional (800mA) pulse amplitude with right unilateral electrode placement. This investigation only includes the single open-label arm.
Device: Mecta Spectrum 5000Q paired with Soterix Medical 4X1 HD - ECT Multi-Channel Stimulation Interface
The Mecta Spectrum 5000Q paired with Soterix Medical 4X1 HD-ECT Multi-Channel Stimulation Interface will reduce ECT current amplitude for amplitude-seizure titration.




Primary Outcome Measures :
  1. Inventory of Depressive Symptomatology - Clinician (IDS-C) [ Time Frame: The time frame is four weeks (before and after the ECT series). ]
    The IDS-C is a clinician rating of depression severity. The scoring range is from 0 to 84 with higher scores related to higher depression severity.


Secondary Outcome Measures :
  1. Delis-Kaplan Executive Function System verbal fluency (DKEFS) test score [ Time Frame: The time frame is four weeks (before and after the ECT series). ]
    The DKEFS-VF is a neuropsychological measure of executive functioning. The scoring range (scaled scores) is between 1 to 19 with higher scores related to superior executive functioning.



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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of major depressive disorder
  • Clinical indications for ECT with right unilateral electrode placement
  • Right-handed
  • Age range between 50 and 80 years

Exclusion Criteria:

  • Defined neurological or neurodegenerative disorder (e.g., traumatic brain injury, epilepsy, Alzheimer's disease)
  • Other psychiatric conditions (e.g., schizophrenia, bipolar disorder)
  • Current drug or alcohol use disorder (except for nicotine); and 4) contraindications to MRI.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04621786


Contacts
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Contact: Christopher Abbott, MD 5052723507 cabbott@salud.unm.edu
Contact: megan lloyd 5052723507 meglloyd@salud.unm.edu

Locations
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United States, New Mexico
University of New Mexico Recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Chris Abbott, MD    505-272-2223    cabbott@salud.unm.edu   
Contact: Megan Lloyd, MS    5052723507    meglloyd@salud.unm.edu   
Sponsors and Collaborators
University of New Mexico
The Zucker Hillside Hospital
National Institute of Mental Health (NIMH)
The Mind Research Network
University of Texas Southwestern Medical Center
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Responsible Party: University of New Mexico
ClinicalTrials.gov Identifier: NCT04621786    
Other Study ID Numbers: MH125126
MH125126 ( Other Grant/Funding Number: NIMH )
First Posted: November 9, 2020    Key Record Dates
Last Update Posted: May 3, 2021
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by University of New Mexico:
Electroconvulsive Therapy
Depressive Episode
Cognition
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders