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Completed

NCT Number: NCT00597831

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms Intracranial Pressure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

PAAZ Rijnstate Hospital

Arnhem, Gelderland, 6800 TA, Netherlands

About this study

  • Aim:
  • 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.
  • Study design:

a.Observational study: cohort study

  • 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.

  • Endpoints:
  • A minimum of sixteen patients are needed according to the power analysis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Under 18 years of age

Treatment and study plan

Primary outcomes

  1. Pulsatility Index before, during and after electroconvulsive therapy

    Time frame: before, during and after three consecutive ECT treatments

Secondary outcomes

  1. Bloodpressure before, during and after ECT.

    Time frame: before, during and after three consecutive ECT treatments.

Sponsors and collaborators

Lead sponsor

Rijnstate Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jan 18, 2008
Registry last updated
Oct 26, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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