Clinical Outcomes With Electroconvulsive Therapy: Insights From Computational Modelling

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-10

Study Completion Date

2022-06-22

Brief Summary

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

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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.

Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Both participants and the outcome assessor will be blinded.

Study Groups

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Brief Temporoparietal ECT

Brief Pulse Temporoparietal ECT

Group Type ACTIVE_COMPARATOR

Brief Temporoparietal ECT

Intervention Type PROCEDURE

Electroconvulsive Therapy (Brief pulse width, Temporoparietal) The intervention in this study is different combinations of pulse width and ECT electrode placements.

Ultrabrief Temporoparietal ECT

Ultrabrief Pulse Temporoparietal ECT

Group Type ACTIVE_COMPARATOR

Ultrabrief Temporoparietal ECT

Intervention Type PROCEDURE

Electroconvulsive Therapy (Ultrabrief pulse width, Temporoparietal) The intervention in this study is different combinations of pulse width and ECT electrode placements.

Brief Frontoparietal ECT

Brief Pulse Frontoparietal ECT

Group Type ACTIVE_COMPARATOR

Brief Frontoparietal ECT

Intervention Type PROCEDURE

Electroconvulsive Therapy (Brief pulse width, Frontoparietal) The intervention in this study is different combinations of pulse width and ECT electrode placements.

Ultrabrief Frontoparietal ECT

Ultrabrief Pulse Frontoparietal ECT

Group Type ACTIVE_COMPARATOR

Ultrabrief Frontoparietal ECT

Intervention Type PROCEDURE

Electroconvulsive Therapy (Ultrabrief pulse width, Frontoparietal) The intervention in this study is different combinations of pulse width and ECT electrode placements.

Interventions

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Brief Temporoparietal ECT

Electroconvulsive Therapy (Brief pulse width, Temporoparietal) The intervention in this study is different combinations of pulse width and ECT electrode placements.

Intervention Type PROCEDURE

Ultrabrief Temporoparietal ECT

Electroconvulsive Therapy (Ultrabrief pulse width, Temporoparietal) The intervention in this study is different combinations of pulse width and ECT electrode placements.

Intervention Type PROCEDURE

Brief Frontoparietal ECT

Electroconvulsive Therapy (Brief pulse width, Frontoparietal) The intervention in this study is different combinations of pulse width and ECT electrode placements.

Intervention Type PROCEDURE

Ultrabrief Frontoparietal ECT

Electroconvulsive Therapy (Ultrabrief pulse width, Frontoparietal) The intervention in this study is different combinations of pulse width and ECT electrode placements.

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No