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Regulation of Intracerebral Pressure During Electroconvulsive Therapy

Completed
Conditions
Depression
Intracranial Pressure
Registration Number
NCT00597831
Lead Sponsor
Rijnstate Hospital
Brief Summary

The purpose of this study is to determine whether electroconvulsive therapy (ECT) has an influence on pressure within the human brain before, during and after ECT.

Detailed Description

1. Aim:

1. Our main objective concerning this study is to determine to what extent ECT does lead to an increase of the Pulsatility Index (as an indicator of intracerebral pressure) measured by a Transcranial Doppler Device (TCD).

2. As a secondary objective we want to compare the PI measurements with simultaneously measured systemic blood pressure.

2. Study design:

a.Observational study: cohort study

3. Treatment:

a. Treatment as usual, PI and blood pressure measurement at baseline, just before ECT, during and 5 minutes after ECT. Data will be collected during unilateral treatment during 3 consecutive ECT treatments.

4. Endpoints:

1. A minimum of sixteen patients are needed according to the power analysis.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
16
Inclusion Criteria
  • Temporal window to measure PI
  • Major depression
  • Psychotic depression
Exclusion Criteria
  • Under 18 years of age

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Pulsatility Index before, during and after electroconvulsive therapybefore, during and after three consecutive ECT treatments
Secondary Outcome Measures
NameTimeMethod
Bloodpressure before, during and after ECT.before, during and after three consecutive ECT treatments.

Trial Locations

Locations (1)

PAAZ Rijnstate Hospital

🇳🇱

Arnhem, Gelderland, Netherlands

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