Clinical trial NCT00527176: Pulse Corticosteroid Therapy and Effect on Brain Water Diffusivity
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Systemic Lupus Erythematosus
Keywords: Systemic Lupus Erythematosus
Corticosteroid
Pulse therapy
Diffusion weighted imaging
q Space Imaging
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
Collaborators: name: Fonds National de la Recherche Scientifique
First posted: 2007-09-10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: 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 ?


Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Clinique Universitaire St LUC
Study officials:
affiliation: UNIVERSITE CATHOLIQUE DE LOUVAIN
name: Thierry Duprez, MD
role: STUDY_DIRECTOR
affiliation: UNIVERSITE CATHOLIQUE DE LOUVAIN
name: Denis Rommel, MD
role: PRINCIPAL_INVESTIGATOR
References:
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