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Regulation of Intracerebral Pressure During Electroconvulsive Therapy

R

Rijnstate Hospital

Status

Completed

Conditions

Intracranial Pressure
Depression

Study type

Observational

Funder types

Other

Identifiers

NCT00597831
LTC-491/251007

Details and patient eligibility

About

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.

Full 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.

Enrollment

16 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • Under 18 years of age

Trial design

16 participants in 1 patient group

A
Description:
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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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