Prediction of the Cognitive Effects of Electroconvulsive Therapy Via Machine Learning and Neuroimaging (CoEffECT)

May 24, 2022 updated by: Rene Hurlemann, University Hospital, Bonn

The study aims to use machine learning to predict the occurrence of episodic and autobiographical memory deficits as well as treatment response following a course of electroconvulsive therapy. Additionally, the neurophysiological correlates of the cognitive effects after a course of ECT will be investigated.

Therefore, structural, resting-state and diffusion tensor images will be collected within one week before the first and after the last ECT treatment from severely depressed patients. Standard measures of cognitive function and specifically episodic as well as autobiographical memory will also be collected longitudinally and used for prediction. The study consists of 60 ECT receiving inpatients suffering from major unipolar or bipolar depression, 60 medication-only controls and 60 healthy controls.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Due to the immense disease burden of major depression and unsatisfactory response to standard pharmacological and psychological treatments, the need for treatment alternatives is evident. Electroconvulsive therapy (ECT) remains to be the most efficacious treatment known for treatment-resistant depression. However, although many studies show response rates above 70%, ECT can be considered vastly underused. Reasons contributing to this phenomenon may include stigma, regulatory restrictions, limited medical training, safety and side-effect concerns, or reluctance among professionals to recommend ECT. Most of these reasons have already been refuted or put into perspective by psychological and neuroscientific studies (e.g. ECT causes brain lesions) and most cognitive deficits related to the ECT course seem to fade after several weeks of discontinuation.

Still, in terms of the tolerability, memory disturbances remain the most problematic effect of ECT. Besides subjective reports from patients after a course of ECT, experimental studies have also found evidence of episodic and autobiographical memory impiarment attributable to ECT. The origins of these effects are still largely unknown and remain a goal for further research.

It has now been shown that structural T1 weighted MR-images can be used to predict the response to a course of ECT via machine learning. Therefore, this study aims to use machine learning to predict the occurrence of episodic and specifically autobiographical memory deficits arising within a course of electroconvulsive therapy based on MR-images collected within one week before the first ECT treatment from severely depressed patients. Additionally, the neurophysiological correlates of the cognitive effects modulated by a course of ECT will be investigated longitudinally through the use of structural, resting-state and diffusion tensor images. The study consists of 60 ECT receiving inpatients suffering from major unipolar or bipolar depression.

If successful, this line of research should lead to a better tolerability of ECT by aiding in the complex decision making process involved in prescribing ECT as well as the parameter setting within a treatment course (e.g. uni- vs. bilateral).

Study Type

Observational

Enrollment (Anticipated)

180

Contacts and Locations

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

Study Contact

  • Name: Maximilian Kiebs, M.Sc.
  • Phone Number: 19710 0049228287
  • Email: m.kiebs@ukbonn.de

Study Locations

  • Germany
    • Nordrhein-Westfalen
      • Bonn, Nordrhein-Westfalen, Germany, 53105
        • Recruiting
        • Klinik und Poliklinik für Psychiatrie und Psychotherapie

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

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Inpatients at the psychiatric hospital of the University Hospital Bonn. The patients diagnosis of major depressive disorder will be verified via the structured clinical interview for DSM-5. ECT protocol in line with international standards administered by a staff psychiatrist.

Additionally, a medication-only and a healthy control sample are included in the study.

Description

Inclusion Criteria:

  • The duration of the current depressive episode is at least four weeks
  • The duration of the current depressive episode is less than five years
  • Inpatients of the psychiatric clinic of the University Hospital Bonn and eligible for ECT because of major depressive disorder or major depressive episode in bipolar disorder (according to DSM-5 criteria)
  • Score on HDRS 28 ≥ 20
  • Ability to understand the purpose of and procedures required for the study and willingness to consent to participation
  • Meeting of standard medical prerequisites for ECT (judged by staff psychiatrist)
  • Ability to speak and understand the german language

Exclusion Criteria:

  • No lifetime occurence of a personality disorder
  • Current (or within the last year) posttraumatic stress disorder
  • Schizophrenia or any other psychotic disorder except for psychotic depression
  • Severe somatic or neurological condition (e.g. stroke)
  • Head trauma resulting in unconsciousness for more than 5 minutes
  • Pregnancy
  • Maintenance ECT or ECT received during the last 6 month
  • Subjects who do not consent to be informed of incidental findings that could have healthcare implications
  • Drug or alcohol dependence (<6 month before ECT)
  • Is currently enrolled in a study with an investigational study drug
  • Has any condition that, in the opinion of the investigator, would compromise the wellbeing of the subject or the study or prevent the subject from meeting or performing study requirements

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

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy controls
ECT
Device: Electroconvulsive Therapy
Series of electroconvulsive therapy for major depressive disorder
Medication - Treatment as usual
Drug: Medication - Treatment as usual
Medication only sample - Treatment as usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in auditory verbal learning performance
Time Frame: Within one week before first and one week after last ECT
Auditory Verbal Learning Test (AVLT)
Within one week before first and one week after last ECT
Change in autobiographical memory performance
Time Frame: Within one week before first and one week after last ECT
Autobiographical Memory Interview (AMI-SF)
Within one week before first and one week after last ECT
Change in subjective memory impairment
Time Frame: Within one week before first and one week after last ECT
Qualitative Interview
Within one week before first and one week after last ECT
Occurence of retrograde amnesia
Time Frame: Within the first week after last ECT
Within the first week after last ECT

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in depression severity as measured by the Hamilton Depression Rating Scale (HDRS 28).
Time Frame: One week before first and one week after last ECT
Hamilton Depression Rating Scale (HDRS 28). Remission defined as Hamilton Depression Rating Scale-28 score of less than or equal to 9 after the ECT course. Response defined as min. -50% change in Hamilton Depression Rating Scale-28 score after ECT.
One week before first and one week after last ECT
Change in depression severity as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS)
Time Frame: One week before first and one week after last ECT
Montgomery-Åsberg Depression Rating Scale (MADRS). Remission defined as Montgomery-Åsberg Depression Rating Scale score of less than or equal to 7 after the ECT course. Response defined as min. -50% change in Montgomery-Åsberg Depression Rating Scale score after ECT.
One week before first and one week after last ECT

Collaborators and Investigators

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

Sponsor

University Hospital, Bonn

Collaborators

Maximilian Kiebs, M.Sc. - University Hospital Bonn (Department of Medical Psychology)

Investigators

  • Study Director: Rene Hurlemann, Prof., University Hospital, Bonn

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 (Actual)

January 2, 2018

Primary Completion (Actual)

December 1, 2021

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

March 29, 2018

First Submitted That Met QC Criteria

April 5, 2018

First Posted (Actual)

April 6, 2018

Study Record Updates

Last Update Posted (Actual)

May 25, 2022

Last Update Submitted That Met QC Criteria

May 24, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CoEffECT - Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

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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