Regulation of Intracerebral Pressure During Electroconvulsive Therapy
|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|