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Clinical Outcomes With Electroconvulsive Therapy: Insights From Computational Modelling

Primary Purpose

Depression

Status
Unknown status
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
Brief Temporoparietal ECT
Ultrabrief Temporoparietal ECT
Brief Frontoparietal ECT
Ultrabrief Frontoparietal ECT
Sponsored by
The University of New South Wales
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring electroconvulsive therapy, computer modelling

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Wesley Hospital KogarahRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Brief Temporoparietal ECT

Ultrabrief Temporoparietal ECT

Brief Frontoparietal ECT

Ultrabrief Frontoparietal ECT

Arm Description

Brief Pulse Temporoparietal ECT

Ultrabrief Pulse Temporoparietal ECT

Brief Pulse Frontoparietal ECT

Ultrabrief Pulse Frontoparietal ECT

Outcomes

Primary Outcome Measures

HVLT-R
Hopkins Verbal Learning Test-Revised
BVMT-R
Brief Visual Memory Test-Revised

Secondary Outcome Measures

Full Information

First Posted
September 14, 2017
Last Updated
May 15, 2018
Sponsor
The University of New South Wales
Collaborators
Wesley Mission
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1. Study Identification

Unique Protocol Identification Number
NCT03297411
Brief Title
Clinical Outcomes With Electroconvulsive Therapy: Insights From Computational Modelling
Official Title
Clinical Outcomes With Electroconvulsive Therapy: Insights From Computational Modelling
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 10, 2017 (Actual)
Primary Completion Date
June 22, 2022 (Anticipated)
Study Completion Date
June 22, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of New South Wales
Collaborators
Wesley Mission

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
electroconvulsive therapy, computer modelling

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
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
ParticipantOutcomes Assessor
Masking Description
Both participants and the outcome assessor will be blinded.
Allocation
Randomized
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Brief Temporoparietal ECT
Arm Type
Active Comparator
Arm Description
Brief Pulse Temporoparietal ECT
Arm Title
Ultrabrief Temporoparietal ECT
Arm Type
Active Comparator
Arm Description
Ultrabrief Pulse Temporoparietal ECT
Arm Title
Brief Frontoparietal ECT
Arm Type
Active Comparator
Arm Description
Brief Pulse Frontoparietal ECT
Arm Title
Ultrabrief Frontoparietal ECT
Arm Type
Active Comparator
Arm Description
Ultrabrief Pulse Frontoparietal ECT
Intervention Type
Procedure
Intervention Name(s)
Brief Temporoparietal ECT
Intervention Description
Electroconvulsive Therapy (Brief pulse width, Temporoparietal) The intervention in this study is different combinations of pulse width and ECT electrode placements.
Intervention Type
Procedure
Intervention Name(s)
Ultrabrief Temporoparietal ECT
Intervention Description
Electroconvulsive Therapy (Ultrabrief pulse width, Temporoparietal) The intervention in this study is different combinations of pulse width and ECT electrode placements.
Intervention Type
Procedure
Intervention Name(s)
Brief Frontoparietal ECT
Intervention Description
Electroconvulsive Therapy (Brief pulse width, Frontoparietal) The intervention in this study is different combinations of pulse width and ECT electrode placements.
Intervention Type
Procedure
Intervention Name(s)
Ultrabrief Frontoparietal ECT
Intervention Description
Electroconvulsive Therapy (Ultrabrief pulse width, Frontoparietal) The intervention in this study is different combinations of pulse width and ECT electrode placements.
Primary Outcome Measure Information:
Title
HVLT-R
Description
Hopkins Verbal Learning Test-Revised
Time Frame
Approximately 30 min after ECT treatment
Title
BVMT-R
Description
Brief Visual Memory Test-Revised
Time Frame
Approximately 30 min after ECT treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Feng Lin, MD
Phone
+612 9382 8318
Email
feng.lin@student.unsw.edu.au
First Name & Middle Initial & Last Name or Official Title & Degree
Colleen Loo, MBBS
Phone
+612 9113 2039
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Colleen Loo, MBBS
Organizational Affiliation
The University of New South Wales
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wesley Hospital Kogarah
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Feng Lin, MD
Phone
+612 9383 8318

12. IPD Sharing Statement

Learn more about this trial

Clinical Outcomes With Electroconvulsive Therapy: Insights From Computational Modelling

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