Electroconvulsive Therapy Amplitude Titration

Sponsor

University of New Mexico (Other)

Overall Status

Recruiting

CT.gov ID

NCT04621786

Collaborator

The Zucker Hillside Hospital (Other), National Institute of Mental Health (NIMH) (NIH), The Mind Research Network (Other), University of Texas Southwestern Medical Center (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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.

Study Design

Study Type:

Interventional

Anticipated 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 :

Mar 1, 2021

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 30, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Inventory of Depressive Symptomatology - Clinician (IDS-C) [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

Delis-Kaplan Executive Function System verbal fluency (DKEFS) test score [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of New Mexico	Albuquerque	New Mexico	United States	87131

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of New Mexico

ClinicalTrials.gov Identifier:

NCT04621786

Other Study ID Numbers:

MH125126
MH125126

First Posted:

Nov 9, 2020

Last Update Posted:

Jan 4, 2022

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

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:

Depressive Disorder

Depressive Disorder, Major

Study Results

No Results Posted as of Jan 4, 2022