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Clinical Outcomes With Electroconvulsive Therapy: Insights From Computational Modelling

T

The University of New South Wales

Status and phase

Unknown
Phase 2

Conditions

Depression

Treatments

Procedure: Brief Temporoparietal ECT
Procedure: Ultrabrief Frontoparietal ECT
Procedure: Ultrabrief Temporoparietal ECT
Procedure: Brief Frontoparietal ECT

Study type

Interventional

Funder types

Other

Identifiers

NCT03297411
HC17286

Details and patient eligibility

About

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

Full 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.

Enrollment

15 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

15 participants in 4 patient groups

Brief Temporoparietal ECT
Active Comparator group
Description:
Brief Pulse Temporoparietal ECT
Treatment:
Procedure: Brief Temporoparietal ECT
Ultrabrief Temporoparietal ECT
Active Comparator group
Description:
Ultrabrief Pulse Temporoparietal ECT
Treatment:
Procedure: Ultrabrief Temporoparietal ECT
Brief Frontoparietal ECT
Active Comparator group
Description:
Brief Pulse Frontoparietal ECT
Treatment:
Procedure: Brief Frontoparietal ECT
Ultrabrief Frontoparietal ECT
Active Comparator group
Description:
Ultrabrief Pulse Frontoparietal ECT
Treatment:
Procedure: Ultrabrief Frontoparietal ECT

Trial contacts and locations

1

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Central trial contact

Feng Lin, MD; Colleen Loo, MBBS

Data sourced from clinicaltrials.gov

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