Optimisation of ECT Based on ASTI vs Narcotrend

NCT ID: NCT04657575

Last Updated: 2023-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2023-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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ASTI

ECT guided with ASTi 2-4 min

Group Type NO_INTERVENTION

No interventions assigned to this group

Narcotrend

ECT guided with ECT

Group Type ACTIVE_COMPARATOR

Narcotrend

Intervention Type PROCEDURE

ECT stimulation within an anaesthesia depth range of 41-64

Interventions

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Narcotrend

ECT stimulation within an anaesthesia depth range of 41-64

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University Innsbruck

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Medical University Hospital Innsbruck

Innsbruck, Tyrol, Austria

Site Status

Countries

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Austria

Other Identifiers

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ECT: ASTI vs Narcotrend

Identifier Type: -

Identifier Source: org_study_id

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