Clinical trial NCT06818656: The Unhide™ Project: Economic Impact Study of IVIG Treatment for PANS
Official title: The Unhide™ Project: Economic Impact Study of IVIG Treatment for PANS
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: PANDAS
PANS
PANS Pediatric Acute-Onset Neuropsychiatric Syndrome
Pediatric Acute-onset Neuropsychiatric Syndrome (PANS)
Pediatric Acute-Onset Neuropsychiatric Syndrome
Pediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal Infections
Keywords: Natural History Study
PANDAS
PANS
IVIG
Immunomodulatory Treatments
Quality of Life
Economic Impacts
Functional Impacts
Healthcare Resource Utilization
Neuroinflammatory Disease
Patient-Reported Outcomes
Decentralized Study
Observational
Lead sponsor: Brain Inflammation Collaborative
Sponsor class: OTHER
Collaborators: name: Stanford University
name: University of California, Los Angeles
First posted: 2025-02-10
Enrollment: 200
Sex: ALL
Minimum age (years): 2
Maximum age (years): 89
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals will be recruited through social media and various online channels.

Brief summary: The Economic Impact Study of IVIG treatment for PANS is a part of the Unhide™ Project, which is a research initiative developed by the Brain Inflammation Collaborative. Specifically, the Unhide™ project is a collection of investigations with the overall goal of better understanding the problems with thinking and mood that can sometimes be symptoms of conditions like autoimmune disease, infection-associated chronic conditions like Long COVID, ME/CFS, PANDAS, PANS, and other illnesses. Your contribution to this research will allow us to better describe these symptoms and understand what causes them, how they develop, and how they can best be treated and prevented.

This study seeks to assess how PANDAS/PANS affects the financial well-being of families who pursue IVIG treatment, as well as the overall health and quality of life of children with the condition. By gathering data through this survey, we aim to gain important insights into the economic consequences of treating - or not treating - PANS with IVIG, including how it impacts parents' ability to work and children's ability to attend school.

Key Eligibility Criteria

* Aged 2-89, U.S. resident, fluent in English, and have access to computer and/or smartphone
* Suspected or confirmed diagnosis of PANS/PANDAS
* Have received IVIG OR have sought and/or been prescribed IVIG but have not received it


Eligibility criteria: Inclusion Criteria:

* Individuals who who have, or have had, a healthcare provider-diagnosed or suspected diagnosis of PANDAS and/or PANS
* Have received IVIG OR have sought and/or been prescribed IVIG but have not received it
* Fluent in English, sufficient to communicate status via the ePRO instrument as required by the protocol
* Is a U.S. resident
* Access to a computer and/or smartphone and the internet, and possessing the ability to operate those devices without assistance from another person (except that children can be assisted by their parents/guardians).

Exclusion Criteria:

* Ward of state
* Failure to meet inclusion criteria

Primary outcomes:
measure: Economic and Quality of Life Impact of IVIG treatment
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Delafield
country: United States
facility: Brain Inflammation Collaborative
state: Wisconsin
Study officials:
References: