Clinical Outcomes With Electroconvulsive Therapy: Insights From Computational Modelling

Phase 2

• Conditions: Depression
• Interventions: Procedure: Brief Frontoparietal ECT; Procedure: Ultrabrief Frontoparietal ECT; Procedure: Brief Temporoparietal ECT; Procedure: Ultrabrief Temporoparietal ECT

• Registration Number: NCT03297411
• Lead Sponsor: The University of New South Wales

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.

Study Timeline

• Study First Submitted: 2017-09-14
• Study First Submitted QC: 2017-09-25
• Study First Posted: 2017-09-29
• Study Start: 2017-10-10
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-15
• Last Update Posted: 2018-05-16
• Primary Completion: 2022-06-22
• Study Completion: 2022-06-22

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Brief Frontoparietal ECT	Brief Frontoparietal ECT	Brief Pulse Frontoparietal ECT
Ultrabrief Frontoparietal ECT	Ultrabrief Frontoparietal ECT	Ultrabrief Pulse Frontoparietal ECT
Brief Temporoparietal ECT	Brief Temporoparietal ECT	Brief Pulse Temporoparietal ECT
Ultrabrief Temporoparietal ECT	Ultrabrief Temporoparietal ECT	Ultrabrief Pulse Temporoparietal ECT

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Wesley Hospital Kogarah; 🇦🇺 Sydney, New South Wales, Australia