ECT Pulse Amplitude and Medial Temporal Lobe Engagement

June 30, 2023 updated by: Christopher Abbott, University of New Mexico
Electroconvulsive therapy (ECT) remains the gold-standard treatment for patients with depressive episodes. During a typical four-week ECT series, most depressive episodes will respond to treatment and people will improve their level of functioning (return to work or family). Independent of the antidepressant effect of ECT, many patients experience transient memory impairment. This investigation will examine the impact of one ECT parameter (pulse amplitude or current) on brain changes (structure of connections within the brain) and clinical outcomes. The goal of this investigation is to determine the optimal parameter for an individual patient that will maintain the clinical response (reduce depression severity) and minimize side effects (eliminate memory issues related to treatment).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Electroconvulsive therapy (ECT) remains the gold-standard treatment for patients with depressive episodes. During a typical four-week ECT series, most depressive episodes remit, and formerly suicidal or psychotically depressed patients will resume their premorbid levels of functioning. Independent of the antidepressant effect of ECT, many patients experience debilitating but transient cognitive effects such as attention and memory deficits. These unwanted side effects are particularly troubling for older patients who are more likely to have existing cognitive deficits. Both the stimulus delivery (electrode placement, pulse amplitude, and pulse width) and seizure induction appear to work in synergy, but the underlying mechanism of action for successful response has yet to be fully elucidated. Moreover, further work is needed to understand the relationship between clinical improvement and cognitive impairment. This investigation will examine the clinical and neurocognitive impact of targeted medial temporal lobe engagement as a function of pulse amplitude, one of several variable factors influencing the ECT charge. The ECT charge is measured in millicoulombs (mC) and derived from multiplying pulse train duration, pulse-pair frequency, pulse width, and pulse amplitude. Pulse amplitude determines the induced electric field strength in the brain and is presently fixed at 900 milliamperes (mA) with no clinical or scientific justification. The central hypothesis of this investigation is that the optimal pulse amplitude for an individual patient will enhance neuroplasticity (clinical response) while minimizing the disruption of dominant hemisphere hippocampal cognitive circuitry (resulting in cognitive stability). The preliminary data informs the dosage range between 600 and 800 mA. Pulse amplitudes outside of this range compromise efficacy (500 mA) or may increase risk of cognitive impairment (900 mA). The first aim of this investigation will identify the electric field strength and neuroplasticity associated with clinical response. Critically, this aim will establish the neuroplasticity threshold, which is defined as the electric field strength necessary to induce neuroplasticity. The second aim will detect the neural correlates of ECT-mediated cognitive changes, which may be related to disrupted dominant hemisphere long-term potentiation. The third aim will use data-driven dual regression to predict the optimal pulse amplitude for an individual patient. This contribution will be significant because the electric field, when manipulated by pulse amplitude, can subsequently maximize hippocampal neuroplasticity (efficacy) and minimize disrupted connectivity (cognitive stability) thus improving clinical outcomes.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
62

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131-0001
        • Chris Abbott

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Diagnosis of major depressive disorder (with or without psychotic features)
  2. the clinical indications for ECT including treatment resistance or a need for a rapid and definitive response
  3. Hamilton Depression Rating Scale 24-item (HDRS-24) > 21
  4. age range between 50 and 80 years of age
  5. right-handedness

Exclusion Criteria:

  1. Defined neurological or neurodegenerative disorder (e.g., history of head injury with loss of consciousness > 5 minutes, epilepsy, Alzheimer's disease)
  2. other psychiatric conditions (e.g., schizophrenia, schizoaffective disorder, bipolar disorder)
  3. current drug or alcohol use disorder, except for nicotine; and 4) contraindications to MRI.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 600 mA Right Unilateral ECT
MECTA Spectrum 5000Q Amplitude
Device: MECTA Spectrum 5000Q Amplitude
Current
Experimental: 700 mA Right Unilateral ECT
MECTA Spectrum 5000Q Amplitude
Device: MECTA Spectrum 5000Q Amplitude
Current
Active Comparator: 800 mA Right Unilateral ECT
MECTA Spectrum 5000Q Amplitude
Device: MECTA Spectrum 5000Q Amplitude
Current

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Depression Severity
Time Frame: post-ECT Hamilton Depression Rating Scale -24 item. The time frame is 4 weeks after study initiation.
Hamilton Depression Rating Scale - 24 item. Scores range from 0 to 76 (higher scores indicate more depression severity)
post-ECT Hamilton Depression Rating Scale -24 item. The time frame is 4 weeks after study initiation.
Cognition
Time Frame: post-ECT Hopkins Verbal Learning Trial-Revised (percent retention score, range 0 - 100, higher is better). The time frame is 4 weeks after study initiation.
Hopkins Verbal Learning Trial-Revised (percent retention score, range 0 - 100, higher is better)
post-ECT Hopkins Verbal Learning Trial-Revised (percent retention score, range 0 - 100, higher is better). The time frame is 4 weeks after study initiation.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Structural magnetic resonance imaging (MRI): Medial temporal lobe volumes
Time Frame: change from pre-ECT baseline (within one week of ECT start) to post-ECT Index (within one week of finishing ECT index)
Medial temporal lobe volumes
change from pre-ECT baseline (within one week of ECT start) to post-ECT Index (within one week of finishing ECT index)
Resting state functional MRI
Time Frame: change from pre-ECT baseline (within one week of ECT start) to post-ECT Index (within one week of finishing ECT index)
resting state medial temporal lobe functional connectivity
change from pre-ECT baseline (within one week of ECT start) to post-ECT Index (within one week of finishing ECT index)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Montreal Cognitive Assessment
Time Frame: change from pre-ECT baseline (within one week of ECT start) to post-ECT Index (within one week of finishing ECT index)
brief cognitive screening
change from pre-ECT baseline (within one week of ECT start) to post-ECT Index (within one week of finishing ECT index)
Hopkins Verbal Learning Trials - Revised
Time Frame: change from pre-ECT baseline (within one week of ECT start) to post-ECT Index (within one week of finishing ECT index)
Verbal memory test (other aspects of test not included as primary outcome)
change from pre-ECT baseline (within one week of ECT start) to post-ECT Index (within one week of finishing ECT index)
Brief Visual Memory Test-Revised
Time Frame: change from pre-ECT baseline (within one week of ECT start) to post-ECT Index (within one week of finishing ECT index)
Visual memory test
change from pre-ECT baseline (within one week of ECT start) to post-ECT Index (within one week of finishing ECT index)
Delis Kaplan Executive Function System (DKEFS) Color Interference
Time Frame: change from pre-ECT baseline (within one week of ECT start) to post-ECT Index (within one week of finishing ECT index)
cognitive measure
change from pre-ECT baseline (within one week of ECT start) to post-ECT Index (within one week of finishing ECT index)
Delis Kaplan Executive Function System (DKEFS) Verbal Fluency
Time Frame: change from pre-ECT baseline (within one week of ECT start) to post-ECT Index (within one week of finishing ECT index)
cognitive measure
change from pre-ECT baseline (within one week of ECT start) to post-ECT Index (within one week of finishing ECT index)
Dot counting
Time Frame: change from pre-ECT baseline (within one week of ECT start) to post-ECT Index (within one week of finishing ECT index)
cognitive measure
change from pre-ECT baseline (within one week of ECT start) to post-ECT Index (within one week of finishing ECT index)
Wechsler Adult Intelligence Scale-4 Digit Span
Time Frame: change from pre-ECT baseline (within one week of ECT start) to post-ECT Index (within one week of finishing ECT index)
cognitive measure
change from pre-ECT baseline (within one week of ECT start) to post-ECT Index (within one week of finishing ECT index)
Autobiographical Memory
Time Frame: change from pre-ECT baseline (within one week of ECT start) to post-ECT Index (within one week of finishing ECT index)
cognitive measure
change from pre-ECT baseline (within one week of ECT start) to post-ECT Index (within one week of finishing ECT index)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of New Mexico

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)
University of Texas
The Mind Research Network

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Chris Abbott, MD, University of New Mexico

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 23, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 23, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 16, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 21, 2016

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 24, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 30, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 5U01MH111826 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

National Data Archive (NDA)

IPD Sharing Time Frame

Clinical, cognitive and MRI data was uploaded to NDA.

IPD Sharing Access Criteria

per NDA protocol

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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