Regulation of Intracerebral Pressure During Electroconvulsive Therapy
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Regulation of Intracerebral Pressure During Electroconvulsive Therapy. Does Systemic Bloodpressure Reflect the Intracranial Pressure?|
- Pulsatility Index before, during and after electroconvulsive therapy [ Time Frame: before, during and after three consecutive ECT treatments ] [ Designated as safety issue: No ]
- Bloodpressure before, during and after ECT. [ Time Frame: before, during and after three consecutive ECT treatments. ] [ Designated as safety issue: No ]
|Study Start Date:||January 2008|
|Study Completion Date:||July 2009|
|Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
All patients in the Rijnstate Hospital with an indication for unilateral ECT treatment and a major depression or psychotic depression according to DSM IV-TR criteria.
- 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).
- As a secondary objective we want to compare the PI measurements with simultaneously measured systemic blood pressure.
a.Observational study: cohort study
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.
- A minimum of sixteen patients are needed according to the power analysis.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00597831
|PAAZ Rijnstate Hospital|
|Arnhem, Gelderland, Netherlands, 6800 TA|
|Principal Investigator:||Roy LE Derikx, MD||Rijnstate Hospital|