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EEG Characteristics in ECT

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ClinicalTrials.gov Identifier: NCT04022226
Recruitment Status : Unknown
Verified July 2019 by Jeremy Miller, University of New Mexico.
Recruitment status was:  Not yet recruiting
First Posted : July 17, 2019
Last Update Posted : July 19, 2019
Sponsor:
Collaborator:
University of New Mexico Clinical & Translational Science Center
Information provided by (Responsible Party):
Jeremy Miller, University of New Mexico

Tracking Information
First Submitted Date  ICMJE July 10, 2019
First Posted Date  ICMJE July 17, 2019
Last Update Posted Date July 19, 2019
Estimated Study Start Date  ICMJE October 1, 2019
Estimated Primary Completion Date October 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 12, 2019)
Clinical Efficacy of ECT [ Time Frame: Outcome measures will be assessed 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. ]
Quick Inventory of Depressive Symptomatology (QIDS) and Self Reporting version (QIDS-SR) - Range 0 - 48 with higher number indicating worsening depression.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 16, 2019)
  • 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
  • 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)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 12, 2019)
  • 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
  • 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)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE EEG Characteristics in ECT
Official Title  ICMJE A Randomized Pilot Study Examining DCEEG Characteristics in Ketamine Versus Methohexital Induction in Depressed Patients Receiving Electroconvulsive Therapy
Brief Summary The investigators will be examining slow-wave characteristics in depressed patients receiving electroconvulsive therapy (ECT) using direct current electroencephalogram (dcEEG) by anesthesia induction agent.
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  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Electroconvulsive Therapy
  • Direct Current Electroencephalogram
  • Ketamine
  • Spreadind Depression
Intervention  ICMJE
  • Drug: Ketamine
    Induction agent that suppresses infra-slow waves
  • Drug: Methohexital
    Induction agent that does not suppress infra-slow waves
Study Arms  ICMJE
  • Active Comparator: Methohexital
    Standard of care anesthesia that does not affect slow wave characteristics
    Intervention: Drug: Methohexital
  • Experimental: Ketamine
    Standard of care anesthesia that suppresses slow wave characteristics
    Intervention: Drug: Ketamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 12, 2019)
26
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 1, 2020
Estimated Primary Completion Date October 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04022226
Other Study ID Numbers  ICMJE 19-228
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
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.
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.
URL: https://digitalrepository.unm.edu/
Responsible Party Jeremy Miller, University of New Mexico
Study Sponsor  ICMJE University of New Mexico
Collaborators  ICMJE University of New Mexico Clinical & Translational Science Center
Investigators  ICMJE Not Provided
PRS Account University of New Mexico
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP