Pulse Corticosteroid Therapy and Effect on Brain Water Diffusivity

Systemic Lupus Erythematosus Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00527176
• Other study ID #: B40320072108
• Status: Recruiting
• Phase: N/A
• First received: September 7, 2007
• Last updated: September 7, 2007
• Start date: September 2007
• Est. completion date: September 2007

Study information

• Verified date: September 2007
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: Thierry Duprez, MD
• Phone: + 32 2 764 29 19
• Email: duprez[@]rdgn.ucl.ac.be
• Is FDA regulated: No
• Health authority: Belgium: Ministry of Social Affairs, Public Health and the Environment
• Study type: Observational

Clinical Trial 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 ?

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 0
• Est. completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Systemic Lupus Erythematosus

• normal neurological exam

• informed consent

• 18 yo or more

Exclusion Criteria:

• abnormal neurological exam

• younger than 18 years old

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Locations

Country	Name	City	State
Belgium	Clinique Universitaire St LUC	Brussels

Sponsors (2)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain	Fonds National de la Recherche Scientifique

Country where clinical trial is conducted

Belgium, 

References & Publications (7)

Bosma GP, Huizinga TW, Mooijaart SP, Van Buchem MA. Abnormal brain diffusivity in patients with neuropsychiatric systemic lupus erythematosus. AJNR Am J Neuroradiol. 2003 May;24(5):850-4. — View Citation

Dehmeshki J, Van Buchem MA, Bosma GP, Huizinga TW, Tofts PS. Systemic lupus erythematosus: diagnostic application of magnetization transfer ratio histograms in patients with neuropsychiatric symptoms--initial results. Radiology. 2002 Mar;222(3):722-8. — View Citation

Moritani T, Hiwatashi A, Shrier DA, Wang HZ, Numaguchi Y, Westesson PL. CNS vasculitis and vasculopathy: efficacy and usefulness of diffusion-weighted echoplanar MR imaging. Clin Imaging. 2004 Jul-Aug;28(4):261-70. — View Citation

Moritani T, Shrier DA, Numaguchi Y, Takahashi C, Yano T, Nakai K, Zhong J, Wang HZ, Shibata DK, Naselli SM. Diffusion-weighted echo-planar MR imaging of CNS involvement in systemic lupus erythematosus. Acad Radiol. 2001 Aug;8(8):741-53. — View Citation

Peterson PL, Howe FA, Clark CA, Axford JS. Quantitative magnetic resonance imaging in neuropsychiatric systemic lupus erythematosus. Lupus. 2003;12(12):897-902. Review. — View Citation

Steens SC, Steup-Beekman GM, Bosma GP, Admiraal-Behloul F, Olofsen H, Doornbos J, Huizinga TW, van Buchem MA. The effect of corticosteroid medication on quantitative MR parameters of the brain. AJNR Am J Neuroradiol. 2005 Nov-Dec;26(10):2475-80. — View Citation

Sun SS, Huang WS, Chen JJ, Chang CP, Kao CH, Wang JJ. Evaluation of the effects of methylprednisolone pulse therapy in patients with systemic lupus erythematosus with brain involvement by Tc-99m HMPAO brain SPECT. Eur Radiol. 2004 Jul;14(7):1311-5. Epub 2003 Dec 9. — View Citation