Clinical Outcomes With Electroconvulsive Therapy: Insights From Computational Modelling

Depression Clinical Trial

Official title:

Clinical Outcomes With Electroconvulsive Therapy: Insights From Computational Modelling

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03297411
• Other study ID #: HC17286
• Status: Recruiting
• Phase: Phase 2
• Start date: October 10, 2017
• Est. completion date: June 22, 2022

Study information

• Verified date: May 2018
• Source: The University of New South Wales
• Contact: Feng Lin, MD
• Phone: +612 9382 8318
• Email: feng.lin[@]student.unsw.edu.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: June 22, 2022
• Est. primary completion date: June 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression

Intervention

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

Locations

Country	Name	City	State
Australia	Wesley Hospital Kogarah	Sydney	New South Wales

Sponsors (2)

Lead Sponsor	Collaborator
The University of New South Wales	Wesley Hospital, Kogarah

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HVLT-R	Hopkins Verbal Learning Test-Revised	Approximately 30 min after ECT treatment
Primary	BVMT-R	Brief Visual Memory Test-Revised	Approximately 30 min after ECT treatment