EEG Characteristics in ECT

August 5, 2024 updated by: Jeremy Miller, University of New Mexico

A Randomized Pilot Study Examining DCEEG Characteristics in Ketamine Versus Methohexital Induction in Depressed Patients Receiving Electroconvulsive Therapy

The investigators will be examining slow-wave characteristics in depressed patients receiving electroconvulsive therapy (ECT) using direct current electroencephalogram (dcEEG) by anesthesia induction agent.

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

This is a pilot project using dcEEG to look at infra-slow waves in depressed patients receiving ECT randomized to ketamine or methohexital where ketamine suppresses infra-slow waves. The rationale for this project is to identify biomarkers of treatment adequacy in ECT, which could lead to decreased morbidity and mortality with the procedure and lessen the burden of depression in our patient population.

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.
11

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.
  • Early Phase 1

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, 87106
        • University of New Mexico Mental Health Center

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Structured Clinical Interview for DSM-5 will confirm diagnosis of MDD or BPD-depressed (with or without psychotic features
  • The clinical indications for ECT including treatment resistance or a need for a rapid and definitive response;
  • Hamilton Depression Rating Scale 24-item (HDRS-24) > 21; and
  • Age range between 18 and 65 years of age.

Exclusion Criteria:

  • Defined neurological or neurodegenerative disorder (e.g., history of head injury with loss of consciousness > 5 minutes, epilepsy, Alzheimer's disease);
  • Other psychiatric conditions (e.g., schizophrenia, schizoaffective disorder, bipolar disorder)
  • Current drug or alcohol use disorder, except for nicotine and marijuana
  • Adults unable to consent, pregnant women, prisoner
  • Non-English speakers
  • Patients that cannot tolerate Methohexital and Ketamine.

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: Diagnostic
  • 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.
Active Comparator: Methohexital
Standard of care anesthesia that does not affect slow wave characteristics
Drug: Methohexital
Induction agent that does not suppress infra-slow waves
Experimental: Ketamine
Standard of care anesthesia that suppresses slow wave characteristics
Drug: Ketamine
Induction agent that suppresses infra-slow waves

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
Number of Participants Assessed for Clinical Efficacy of ECT
Time Frame: 1 year

Quick Inventory of Depressive Symptomatology (QIDS) and Self Reporting version (QIDS-SR) - Range 0 - 48 with higher number indicating worsening depression.

Inadequate sample size due to COVID. Study was closed.
1 year

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
Cognitive performance
Time Frame: Outcome measures assessed at first, second, middle, and final ECT treatment over the course of 1 month on average for each patient. Data will be reported at 1 year.
  • Montreal Cognitive Assessment. Measures global cognitive function. 0-30 with higher score indicates better cognitive function
  • Dot Counting Test measures effort. Time to completion and errors recorded. Higher times/error rates indicate decreased effort
  • Test of Premorbid Function estimates premorbid intellectual function. Negative change indicates greater cognitive & memory function impairment
  • Autobiographical Memory Test. Free recall of retrospective autobiographical memories. 0-20 with higher score indicating improved memory function
  • Hopkins Verbal Learning Test-Revised. Free recall, and recognition memory. Retention % calculated. Higher percentage indicates improved cognitive function
  • Delis Kaplan Executive Function System Color-Word Interference & Verbal Fluency Test. Processing speed, sequencing and cognitive flexibility

This neuropsychological battery will be used to compute composite z-scores that represent global cognitive function at each time point
Outcome measures assessed at first, second, middle, and final ECT treatment over the course of 1 month on average for each patient. Data will be reported at 1 year.
Direct current electroencephalogram slow wave phenomenon (exploratory outcome)
Time Frame: dcEEG data will be collected the first, second, middle, and final ECT treatment over the course of 1 month on average for each patient. Data will be reported at 1 year.
Analysis will assess magnitude of slow-wave phenomena (area under the curve in cm^2)
dcEEG data will be collected the first, second, middle, and final ECT treatment over the course of 1 month on average for each patient. Data will be reported at 1 year.
ECT parameters and their correlation to production of slow-wave phenomenon
Time Frame: This will be assessed throughout the year.
Analysis will correlate electrode placement and pulse width with production of slow-waves on dcEEG.
This will be assessed throughout the year.

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

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 (Actual)

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, 2019

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.
October 1, 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.
October 1, 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).
July 10, 2019

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.
July 12, 2019

First Posted (Actual)

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.
July 17, 2019

Study Record Updates

Last Update Posted (Actual)

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.
October 26, 2024

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.
August 5, 2024

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.
August 1, 2024

More Information

Terms related to this study

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.
  • 19-228

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

An embargo of 2 years will be placed on the data after Master's Thesis is published and placed into the vault to allow for publications. Afterwards, it will be available as along as the vault is maintained.

IPD Sharing Access Criteria

Pilot project is being done as a part of a Master's Thesis which will be uploaded to the University of New Mexico digital repository and may contain supporting information as above.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

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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