Regulation of Intracerebral Pressure During Electroconvulsive Therapy

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00597831
• Other study ID #: LTC-491/251007
• Status: Completed
• Phase: N/A
• First received: January 9, 2008
• Last updated: October 25, 2010
• Start date: January 2008
• Est. completion date: July 2009

Study information

• Verified date: October 2010
• Source: Rijnstate Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Dutch Health Care Inspectorate
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Temporal window to measure PI

• Major depression

• Psychotic depression

Exclusion Criteria:

• Under 18 years of age

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Depression
• Intracranial Pressure

Locations

Country	Name	City	State
Netherlands	PAAZ Rijnstate Hospital	Arnhem	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Rijnstate Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulsatility Index before, during and after electroconvulsive therapy		before, during and after three consecutive ECT treatments	No
Secondary	Bloodpressure before, during and after ECT.		before, during and after three consecutive ECT treatments.	No