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Optimisation of ECT Based on ASTI vs Narcotrend

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ClinicalTrials.gov Identifier: NCT04657575
Recruitment Status : Not yet recruiting
First Posted : December 8, 2020
Last Update Posted : March 2, 2021
Sponsor:
Information provided by (Responsible Party):
Medical University Innsbruck

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Major Depressive Disorder Procedure: Narcotrend Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Optimisation of Electro-Convusions-Therapie (ECT) Based on ASTI (Anaesthesia to Intervention Time Interval) Versus Narcotrend - a Randomised Prosepctive
Estimated Study Start Date : March 1, 2021
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
No Intervention: ASTI
Active Comparator: Narcotrend Procedure: Narcotrend
ECT stimulation within an anaesthesia depth range of 41-64


Outcome Measures
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Primary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04657575


Contacts
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Contact: Lukas Gasteiger, MD +4351250422400 lukas.gasteiger@tirol-kliniken.at
Contact: Wolfgang Lederer, Prof Lukas Gasteiger wolfgang.lederer@i-med.ac.at

Sponsors and Collaborators
Medical University Innsbruck
More Information
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Responsible Party: Medical University Innsbruck
ClinicalTrials.gov Identifier: NCT04657575    
Other Study ID Numbers: ECT: ASTI vs Narcotrend
First Posted: December 8, 2020    Key Record Dates
Last Update Posted: March 2, 2021
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders