Clinical Outcomes With Electroconvulsive Therapy: Insights From Computational Modelling

Sponsor

The University of New South Wales (Other)

Overall Status

Unknown status

CT.gov ID

NCT03297411

Collaborator

Wesley Mission (Other)

Enrollment

Location

Arms

56.4

Anticipated Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Depression	Procedure: Brief Temporoparietal ECT Procedure: Ultrabrief Temporoparietal ECT Procedure: Brief Frontoparietal ECT Procedure: Ultrabrief Frontoparietal ECT	Phase 2

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention 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.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 (Participant, Outcomes Assessor)

Masking Description:

Both participants and the outcome assessor will be blinded.

Primary Purpose:

Treatment

Official Title:

Clinical Outcomes With Electroconvulsive Therapy: Insights From Computational Modelling

Actual Study Start Date :

Oct 10, 2017

Anticipated Primary Completion Date :

Jun 22, 2022

Anticipated Study Completion Date :

Jun 22, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

HVLT-R [Approximately 30 min after ECT treatment]
Hopkins Verbal Learning Test-Revised
BVMT-R [Approximately 30 min after ECT treatment]
Brief Visual Memory Test-Revised

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wesley Hospital Kogarah	Sydney	New South Wales	Australia	2217

Sponsors and Collaborators

The University of New South Wales
Wesley Mission

Investigators

Principal Investigator: Colleen Loo, MBBS, The University of New South Wales

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Colleen Loo, Professor, The University of New South Wales

ClinicalTrials.gov Identifier:

NCT03297411

Other Study ID Numbers:

HC17286

First Posted:

Sep 29, 2017

Last Update Posted:

May 16, 2018

Last Verified:

May 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Colleen Loo, Professor, The University of New South Wales

electroconvulsive therapy

computer modelling

Additional relevant MeSH terms:

Depression

Study Results

No Results Posted as of May 16, 2018