Longitudinal Study for Central Nervous System Vasculitis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Pennsylvania
About this trial
Primary central nervous system vasculitis (CNSV) is a potentially fatal, single-organ vasculitis that often involves a spectrum of neurologic complications, including strokes, cognitive and speech impairment, visual loss, dementia, and encephalopathy. The purpose of this study is to establish a research cohort to investigate the disease process, treatments, and patient outcomes in CNSV.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The presence of an acquired and otherwise unexplained neurologic deficit
The presence of either classic angiographic or histopathologic features of angiitis in the CNS
No evidence of systemic vasculitis or any condition that could cause the angiographic or pathologic features
Disqualifiers
None
Trial population
Individuals with central nervous system vasculitis (CNSV). Enrollment will be sequential and participants will have disease in various stages and of different duration.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Evaluate the pathogenesis of central nervous system vasculitis using disease history.
To study the manner of development of disease in patients affected with central nervous system vasculitis.
Time frame
Study completion; from baseline through month 36.Secondary outcomes
1
PROMIS Questionnaires
Questions will ask about Cognition function on the PROMIS short form.
Time frame
Baseline, month 3, month 6, month 9, month 12, month 18, month 24, month 30, month 362
PROMIS Questionnaires
Questions will ask about depression on the PROMIS short form.
Time frame
Baseline, month 3, month 6, month 9, month 12, month 18, month 24, month 30, month 363
PROMIS Questionnaires
Questions will ask about fatigue on the PROMIS short form.
Time frame
Baseline, month 3, month 6, month 9, month 12, month 18, month 24, month 30, month 364
PROMIS Questionnaires
Questions will ask about Ability to participate in social roles and activities on the PROMIS short form.
Time frame
Baseline, month 3, month 6, month 9, month 12, month 18, month 24, month 30, month 36Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Pennsylvania
Lead sponsor
The Cleveland Clinic
Collaborator
Source ClinicalTrials.gov