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

Sponsor

University Hospital, Bonn (Other)

Overall Status

Recruiting

CT.gov ID

NCT03490149

Collaborator

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

180

Enrollment

Location

58.9

Anticipated Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
ECT Depression Cognitive Impairment Memory Impairment	Device: Electroconvulsive Therapy Drug: Medication - Treatment as usual

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 Design

Study Type:

Observational

Anticipated Enrollment :

180 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 2, 2018

Actual Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
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
Healthy controls

Arm

Intervention/Treatment

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

Healthy controls

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Change in depression severity as measured by the Hamilton Depression Rating Scale (HDRS 28). [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.
Change in depression severity as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

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