NCT04621786

Electroconvulsive Therapy Amplitude Titration

Electroconvulsive Therapy Amplitude Titration for Improved Clinical Outcomes in Late Life Depression

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: University of New Mexico · Academic / Other
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-03-01
• Primary completion: 2022-12-01
• Completion: 2022-12-15
• First posted: 2020-11-09
• Last updated: 2024-01-11
• Results posted: 2023-06-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study