Regulation of Intracerebral Pressure During Electroconvulsive Therapy

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

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 Overview

• Status: Completed
• Conditions: Depression; Intracranial Pressure

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.

• Study Type: Observational
• Enrollment (Anticipated): 16

Contacts and Locations

Study Locations

• Netherlands
  • Gelderland
    • Arnhem, Gelderland, Netherlands, 6800 TA
      • PAAZ Rijnstate Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients indicated for unilateral ECT treatment in the Rijnstate Hospital with the diagnosis major depression and psychotic depressionaccording to DSM IV-TR classification. Patients who already started treatment and patients just starting ECT and are of age > 18 years.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Under 18 years of age

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
A; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pulsatility Index before, during and after electroconvulsive therapy	before, during and after three consecutive ECT treatments

Secondary Outcome Measures

Outcome Measure	Time Frame
Bloodpressure before, during and after ECT.	before, during and after three consecutive ECT treatments.

Collaborators and Investigators

• Sponsor: Rijnstate Hospital
• Investigators: Principal Investigator: Roy LE Derikx, MD, Rijnstate Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): July 1, 2009
• Study Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: January 9, 2008
• First Submitted That Met QC Criteria: January 9, 2008
• First Posted (Estimate): January 18, 2008

Study Record Updates

• Last Update Posted (Estimate): October 26, 2010
• Last Update Submitted That Met QC Criteria: October 25, 2010
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Keywords: depression; intracranial pressure; electroconvulsive therapy; Ultrasonography Doppler Transcranial
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: LTC-491/251007