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Optimisation of ECT Based on ASTI vs Narcotrend

Primary Purpose

Major Depressive Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Narcotrend
Sponsored by
Medical University Innsbruck
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Major Depressive Disorder

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical University Hospital InnsbruckRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

ASTI

Narcotrend

Arm Description

ECT guided with ASTi 2-4 min

ECT guided with ECT

Outcomes

Primary Outcome Measures

Convulsion Quality
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

Secondary Outcome Measures

Full Information

First Posted
November 23, 2020
Last Updated
April 20, 2022
Sponsor
Medical University Innsbruck
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1. Study Identification

Unique Protocol Identification Number
NCT04657575
Brief Title
Optimisation of ECT Based on ASTI vs Narcotrend
Official Title
Optimisation of Electro-Convusions-Therapie (ECT) Based on ASTI (Anaesthesia to Intervention Time Interval) Versus Narcotrend - a Randomised Prosepctive
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University Innsbruck

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ASTI
Arm Type
No Intervention
Arm Description
ECT guided with ASTi 2-4 min
Arm Title
Narcotrend
Arm Type
Active Comparator
Arm Description
ECT guided with ECT
Intervention Type
Procedure
Intervention Name(s)
Narcotrend
Intervention Description
ECT stimulation within an anaesthesia depth range of 41-64
Primary Outcome Measure Information:
Title
Convulsion Quality
Description
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
Time Frame
One hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lukas Gasteiger, MD
Phone
+4351250422400
Email
lukas.gasteiger@tirol-kliniken.at
First Name & Middle Initial & Last Name or Official Title & Degree
Wolfgang Lederer, Prof
Phone
Lukas Gasteiger
Email
wolfgang.lederer@i-med.ac.at
Facility Information:
Facility Name
Medical University Hospital Innsbruck
City
Innsbruck
State/Province
Tyrol
ZIP/Postal Code
6020
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lukas
Phone
+4351250422400
Email
lukas.gasteiger@tirol-kliniken.at

12. IPD Sharing Statement

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Optimisation of ECT Based on ASTI vs Narcotrend

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