Electroconvulsive Therapy Amplitude Titration

NCT04621786 | Completed Results DMC FDA Device

• 1 other identifier: MH125126
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

Electroconvulsive Therapy; Depressive Episode; Cognition

Outcome Measures

Primary Outcomes (1)

• Beta Coefficient From Linear Regression of Amplitude-determined Seizure (Independent Variable) and Ebrain (Dependent Variable)

  Electric field modeling is used to calculate Ebrain from the pre-ECT structural MRI. Ebrain is an individual's electric field strength (Volts/meter) per unit current (milliampere). To avoid confounds from the tissue boundary effects, Ebrain is calculated as the 90th percentile of maximal. Higher values (0.2 Volts/meter per milliampere) indicate that an individual receives a higher electric field strength per unit current. The Ebrain in this sample ranges from 0.1 to 0.19 Volts/meter per milliampere. Linear regression model assessed the relationship between amplitude-determined seizure (independent variable) and Ebrain (dependent variable) with beta coefficient and 95% confidence intervals.

  First treatment

Study Arms (1)

Experimental arm

EXPERIMENTAL

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

Interventions

Mecta Spectrum 5000Q paired with Soterix Medical 4X1 HD - ECT Multi-Channel Stimulation Interface DEVICE

The Mecta Spectrum 5000Q paired with Soterix Medical 4X1 HD-ECT Multi-Channel Stimulation Interface will reduce ECT current amplitude for amplitude-seizure titration.

Experimental arm

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of New Mexico: lead
• The Zucker Hillside Hospital: collaborator
• National Institute of Mental Health (NIMH): collaborator
• The Mind Research Network: collaborator
• University of Texas Southwestern Medical Center: collaborator

Study Sites (1)

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Chris Abbott
• Organization: University of New Mexico

cabbott@salud.unm.edu

5052720406

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Subject and outcomes assessor were blinded to amplitude titration
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2020
• First Posted: November 9, 2020
• Study Start: March 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 15, 2022
• Last Updated: January 11, 2024
• Results First Posted: June 1, 2023

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)