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Clinical Trials/NCT00597831
NCT00597831
Completed
Not Applicable

Regulation of Intracerebral Pressure During Electroconvulsive Therapy. Does Systemic Bloodpressure Reflect the Intracranial Pressure?

Rijnstate Hospital1 site in 1 country16 target enrollmentJanuary 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depression
Sponsor
Rijnstate Hospital
Enrollment
16
Locations
1
Primary Endpoint
Pulsatility Index before, during and after electroconvulsive therapy
Status
Completed
Last Updated
15 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2008
End Date
July 2009
Last Updated
15 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Rijnstate Hospital

Eligibility Criteria

Inclusion Criteria

  • Temporal window to measure PI
  • Major depression
  • Psychotic depression

Exclusion Criteria

  • Under 18 years of age

Outcomes

Primary Outcomes

Pulsatility Index before, during and after electroconvulsive therapy

Time Frame: before, during and after three consecutive ECT treatments

Secondary Outcomes

  • Bloodpressure before, during and after ECT.(before, during and after three consecutive ECT treatments.)

Study Sites (1)

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