Clinical Outcomes With Electroconvulsive Therapy: Insights From Computational Modelling

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

Study Overview

• Status: Unknown
• Conditions: Depression
• Intervention / Treatment: Procedure: Brief Temporoparietal ECT; Procedure: Ultrabrief Temporoparietal ECT; Procedure: Brief Frontoparietal ECT; Procedure: Ultrabrief Frontoparietal ECT

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 Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Feng Lin, MD; Phone Number: +612 9382 8318; Email: feng.lin@student.unsw.edu.au
• Study Contact Backup: Name: Colleen Loo, MBBS; Phone Number: +612 9113 2039

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia, 2217
      • Recruiting
      • Wesley Hospital Kogarah
      • Contact: Feng Lin, MD; Phone Number: +612 9383 8318

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The University of New South Wales
• Collaborators: Wesley Mission

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2017
• Primary Completion (Anticipated): June 22, 2022
• Study Completion (Anticipated): June 22, 2022

Study Registration Dates

• First Submitted: September 14, 2017
• First Submitted That Met QC Criteria: September 25, 2017
• First Posted (Actual): September 29, 2017

Study Record Updates

• Last Update Posted (Actual): May 16, 2018
• Last Update Submitted That Met QC Criteria: May 15, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: electroconvulsive therapy; computer modelling
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: HC17286

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No