Investigating brain connections and immune responses in lupus patients
Neuron-specific Humoral and Cellular Immune Correlates of Structural and Functional Brain Connectomics in Neuropsychiatric Lupus
This study is trying to see how the immune system and brain connections are related in lupus patients who have mental health symptoms, to help improve diagnosis and treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 15 Years and up |
| Sex | All |
| Sponsor | IRCCS San Raffaele Academic / other |
| Locations | 1 site (Milano) |
| Trial ID | NCT05880121 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the relationship between immune responses and brain connectivity in patients with systemic lupus erythematosus (SLE), particularly those with neuropsychiatric symptoms. Patients with SLE and healthy subjects will undergo advanced magnetic resonance imaging (MRI) to assess structural and functional brain architecture. The study will integrate MRI data with brain transcriptome atlases to identify potential autoantigens associated with neuropsychiatric lupus. The findings could enhance understanding of NPSLE pathophysiology and lead to improved diagnostic tools and personalized treatment options.
Who should consider this trial
Good fit: Ideal candidates include adults and adolescents diagnosed with systemic lupus erythematosus, as well as healthy individuals for comparison.
Not a fit: Patients with contraindications to MRI or those with a history of certain cancers or brain disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide new insights into the mechanisms of neuropsychiatric lupus and lead to better diagnostic and treatment strategies for affected patients.
How similar studies have performed: While the specific approach of integrating immune correlates with brain connectomics in NPSLE is novel, similar studies have shown promise in understanding autoimmune diseases and their neurological manifestations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Patients with SLE * Diagnosis of SLE according to the ACR 1997, SLICC 2012 or EULAR/ACR 2019 criteria * age ≥ 18 years (reference centre) * age 15-17 years (affiliated centre) Healthy subjects * Charlson's Comorbidity Index=0 and no chronic treatment * age ≥ 18 years (reference centre) * age 15-17 years (affiliated centre) Exclusion Criteria: * History of T-cell neoplasia * Active B-cell neoplasia or history of B-cell neoplasia of less than five years * Contraindications to MRI * Pregnancy * Ongoing or past treatment with T-depleting agents * History of brain cancer * History of congenital brain disorders * Cerebral disorders secondary to trauma, toxins or other metabolic or environmental factors unrelated to SLE according to the Investigator's evaluation * Any other condition conferring excessive physical and psychological risk to the subject according to the Investigator's opinion
Where this trial is running
Milano
- IRCCS Ospedale San Raffaele — Milano, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.