Clinical Outcomes With Electroconvulsive Therapy: Insights From Computational Modelling

Study Overview
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Brief Summary
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This study will generate new information on how to optimise brain targets with ECT stimulation.

Detailed Description
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This study will differentiate the brain regions which are related to the effectiveness of electroconvulsive therapy (ECT) as a treatment, from the brain regions associated with memory impairment, with ECT stimulation. This will be done by 1) testing effects on memory of 4 different forms of ECT, which stimulate the brain differently; 2) in a subset of participants, use computer modelling to assess the pattern of brain stimulation with the 4 forms of ECT, and match these results to memory outcomes.

Official Title
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Clinical Outcomes With Electroconvulsive Therapy: Insights From Computational Modelling

Conditions
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Depression

Intervention / Treatment
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* Procedure: Brief Temporoparietal ECT
* Procedure: Ultrabrief Temporoparietal ECT
* Procedure: Brief Frontoparietal ECT
* Procedure: Ultrabrief Frontoparietal ECT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged ≥18 years; right-handed DSM-5 Major Depressive Episode Prescribed with a course of ECT Exclusion Criteria: Diagnosis (as defined by DSM-V) of psychotic disorder (apart from Major Depressive Episode with Psychotic features), current drug or alcohol abuse or dependence; ECT treatments in last 3 months from a prior course of ECT; Score <23 on the Montreal Cognitive Assessment Battery (MoCA); Past or current neurological illness or injury, medical illness which may significantly affect neuropsychological function; Inability to give informed consent or comply with study procedures; or Not having worked or studied in an English speaking background (to ensure validity of neuropsychological testing). Not be claustrophobic (if having an MRI brain scan). Not have any metal in your head or body (if having an MRI brain scan). Likely non response to RUL forms of ECT, as indicated by past non response to RUL ECT

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Each participant will be randomly allocated to a sequence of treatments using designs for crossover studies with fewer periods (3) than treatments (4) involving two sets of ECT electrode placements and two sets of pulse width.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Brief Temporoparietal ECT<br>Brief Pulse Temporoparietal ECT | Procedure: Brief Temporoparietal ECT<br>* Electroconvulsive Therapy (Brief pulse width, Temporoparietal) The intervention in this study is different combinations of pulse width and ECT electrode placements.<br>|
| Active Comparator: Ultrabrief Temporoparietal ECT<br>Ultrabrief Pulse Temporoparietal ECT | Procedure: Ultrabrief Temporoparietal ECT<br>* Electroconvulsive Therapy (Ultrabrief pulse width, Temporoparietal) The intervention in this study is different combinations of pulse width and ECT electrode placements.<br>|
| Active Comparator: Brief Frontoparietal ECT<br>Brief Pulse Frontoparietal ECT | Procedure: Brief Frontoparietal ECT<br>* Electroconvulsive Therapy (Brief pulse width, Frontoparietal) The intervention in this study is different combinations of pulse width and ECT electrode placements.<br>|
| Active Comparator: Ultrabrief Frontoparietal ECT<br>Ultrabrief Pulse Frontoparietal ECT | Procedure: Ultrabrief Frontoparietal ECT<br>* Electroconvulsive Therapy (Ultrabrief pulse width, Frontoparietal) The intervention in this study is different combinations of pulse width and ECT electrode placements.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HVLT-R | Hopkins Verbal Learning Test-Revised | Approximately 30 min after ECT treatment | 
| BVMT-R | Brief Visual Memory Test-Revised | Approximately 30 min after ECT treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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computer modelling, electroconvulsive therapy