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Pulse Corticosteroid Therapy and Effect on Brain Water Diffusivity

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2007 by Cliniques universitaires Saint-Luc- Université Catholique de Louvain.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00527176
First Posted: September 10, 2007
Last Update Posted: September 10, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Fonds National de la Recherche Scientifique
Information provided by:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
  Purpose

In daily clinical use, pulse high dosis corticosteroids are used to treat cerebral edema in different pathological situations ( surgery, trauma, tumors...). Dehydration can theorically concern extra-cellular or intracellular water, or both.

The relative proportion of those two components are not known, as well their kinetics.

Diffusion Weighted Imaging ( DWI) is a none invasive and none toxic technique to study those phenomena.We can also study the diffusivity anisotropy not using a Gaussian distribution but rather a non- gaussian one, more close to the reality ( q Space Imaging ).

Finally, we can study the compartment redistribution between slow and rapid water molecules diffusion by bi-exponential decomposition of the diffusion signal, corresponding, theorically, respectively to the intra- and extra-cellular component.

Hypothesis : The high dosis steroid pulse therapy modifies or not the water free diffusion in DWI and qSI ? Is there a modification in the diffusivity of both rapid and slow component ?


Condition
Systemic Lupus Erythematosus

Study Type: Observational
Study Design: Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:

Study Start Date: September 2007
Estimated Study Completion Date: September 2007
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Systemic Lupus Erythematosus
  • normal neurological exam
  • informed consent
  • 18 yo or more

Exclusion Criteria:

  • abnormal neurological exam
  • younger than 18 years old
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00527176


Contacts
Contact: Thierry Duprez, MD + 32 2 764 29 19 duprez@rdgn.ucl.ac.be
Contact: Denis J Rommel, MD denis.rommel@clin.ucl.ac.be

Locations
Belgium
Clinique Universitaire St LUC Recruiting
Brussels, Belgium, 1200
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Fonds National de la Recherche Scientifique
Investigators
Study Director: Thierry Duprez, MD Universite Catholique de Louvain
Principal Investigator: Denis Rommel, MD Universite Catholique de Louvain
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00527176     History of Changes
Other Study ID Numbers: B40320072108
First Submitted: September 7, 2007
First Posted: September 10, 2007
Last Update Posted: September 10, 2007
Last Verified: September 2007

Keywords provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:
Systemic Lupus Erythematosus
Corticosteroid
Pulse therapy
Diffusion weighted imaging
q Space Imaging

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases