Regulation of Intracerebral Pressure During Electroconvulsive Therapy
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|ClinicalTrials.gov Identifier: NCT00597831|
Recruitment Status : Completed
First Posted : January 18, 2008
Last Update Posted : October 26, 2010
|Condition or disease|
|Depression Intracranial Pressure|
- 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.
|Study Type :||Observational|
|Estimated Enrollment :||16 participants|
|Official Title:||Regulation of Intracerebral Pressure During Electroconvulsive Therapy. Does Systemic Bloodpressure Reflect the Intracranial Pressure?|
|Study Start Date :||January 2008|
|Actual Primary Completion Date :||July 2009|
|Actual Study Completion Date :||July 2009|
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.
- Pulsatility Index before, during and after electroconvulsive therapy [ Time Frame: before, during and after three consecutive ECT treatments ]
- Bloodpressure before, during and after ECT. [ Time Frame: before, during and after three consecutive ECT treatments. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00597831
|PAAZ Rijnstate Hospital|
|Arnhem, Gelderland, Netherlands, 6800 TA|
|Principal Investigator:||Roy LE Derikx, MD||Rijnstate Hospital|