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Completed

NCT Number: NCT04657575

Optimisation of ECT Based on ASTI vs Narcotrend

The Electro-Convulsion-Therapy (ECT) is a well accepted treatment option in severe depression. The quality of ECT is evaluated basing on minimal seizure duration (>15sec), the sympathic response and the postictal EEG-suppression.

- Page 1 of 3 - For the treatment general anaesthesia is needed. On the other hand anaesthesia strongly influences the quality of the seizure. Standard treatment is to use Anaesthesia to intervention time (ASTI) of 1 to 2 minutes for ideal timing of the electric stimulation.

The aim of the study is to assess if timing of electric stimulation aiming for ar an anaesthesia depth of Narcotrend values 41-64 may provide better convulsion quality than standard approach of using ASTI 1-2 minutes.

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University Hospital Innsbruck

Innsbruck, Tyrol, 6020, Austria

About this study

The Electro-Convulsion-Therapy (ECT) is a well accepted treatment option in severe depression. The quality of ECT is evaluated basing on minimal seizure duration (>15sec), the sympathic response and the postictal EEG-suppression.

  • Page 1 of 3 - For the treatment general anaesthesia is needed. On the other hand anaesthesia strongly influences the quality of the seizure. Standard treatment is to use Anaesthesia to intervention time (ASTI) of 1 to 2 minutes for ideal timing of the electric stimulation.

The aim of the study is to assess if timing of electric stimulation aiming for ar an anaesthesia depth of Narcotrend values 41-64 may provide better convulsion quality than standard approach of using ASTI 1-2 minutes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ASA 1-3
  • Age: 18 -90 years
  • Signed informed consent
  • Severe depressive disorder

Exclusion criteria

  • ASA >3
  • Age < 18 or > 90
  • denial of the patient
  • Impossibility to fix Narcotrend electrodes
  • Patients unable to consent
  • Pregnancy

Treatment and study plan

Narcotrend

Procedure

ECT stimulation within an anaesthesia depth range of 41-64

Primary outcomes

  1. Convulsion Quality

    Time frame: One hour

    Adequate seizure quality was defined as > 20 seconds motor response on the right forearm, >25 seconds EEG seizure activity, postictal suppression index > 80%, maximum sustained coherence > 90% and 5.midictal amplitude > 180µV

Sponsors and collaborators

Lead sponsor

Medical University Innsbruck

Other

Registry information

Official study title

Optimisation of Electro-Convusions-Therapie (ECT) Based on ASTI (Anaesthesia to Intervention Time Interval) Versus Narcotrend - a Randomised Prosepctive

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Dec 8, 2020
Registry last updated
Nov 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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