Clincosm LogoSign in Get a demo

Regulation of Intracerebral Pressure During Electroconvulsive Therapy

Sponsor
Rijnstate Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT00597831
Collaborator
(none)
16
Enrollment
1
Location
18
Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    1. Aim:

    2. 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).

    3. As a secondary objective we want to compare the PI measurements with simultaneously measured systemic blood pressure.

    4. Study design:

    a.Observational study: cohort study

    1. Treatment:
    1. 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.

    1. Endpoints:

    2. A minimum of sixteen patients are needed according to the power analysis.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    16 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Regulation of Intracerebral Pressure During Electroconvulsive Therapy. Does Systemic Bloodpressure Reflect the Intracranial Pressure?
    Study Start Date :
    Jan 1, 2008
    Actual Primary Completion Date :
    Jul 1, 2009
    Actual Study Completion Date :
    Jul 1, 2009

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Pulsatility Index before, during and after electroconvulsive therapy [before, during and after three consecutive ECT treatments]

    Secondary Outcome Measures

    1. Bloodpressure before, during and after ECT. [before, during and after three consecutive ECT treatments.]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Temporal window to measure PI

    • Major depression

    • Psychotic depression

    Exclusion Criteria:
    • Under 18 years of age

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 PAAZ Rijnstate Hospital Arnhem Gelderland Netherlands 6800 TA

    Sponsors and Collaborators

    • Rijnstate Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00597831
    Other Study ID Numbers:
    • LTC-491/251007
    First Posted:
    Jan 18, 2008
    Last Update Posted:
    Oct 26, 2010
    Last Verified:
    Oct 1, 2010
    Keywords provided by , ,
    depression
    electroconvulsive therapy
    Ultrasonography Doppler Transcranial
    intracranial pressure
    Additional relevant MeSH terms:
    Depression

    Study Results

    No Results Posted as of Oct 26, 2010