Optimisation of ECT Based on ASTI vs Narcotrend

November 2, 2023 updated by: Medical University Innsbruck

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
    • Tyrol
      • Innsbruck, Tyrol, Austria, 6020
        • Medical University Hospital Innsbruck

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: ASTI
ECT guided with ASTi 2-4 min
Active Comparator: Narcotrend
ECT guided with ECT
Procedure: Narcotrend
ECT stimulation within an anaesthesia depth range of 41-64

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
One hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University Innsbruck

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Actual)

February 28, 2023

Study Completion (Actual)

February 28, 2023

Study Registration Dates

First Submitted

November 23, 2020

First Submitted That Met QC Criteria

December 1, 2020

First Posted (Actual)

December 8, 2020

Study Record Updates

Last Update Posted (Estimated)

November 3, 2023

Last Update Submitted That Met QC Criteria

November 2, 2023

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECT: ASTI vs Narcotrend

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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