The Unhide™ Project: Economic Impact Study of IVIG Treatment for PANS

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

Study Overview

• Status: Completed
• Conditions: PANDAS; PANS; Pediatric Autoimmune Neuropsychiatric Disorders Associated With Streptococcal Infections; Pediatric Acute-onset Neuropsychiatric Syndrome (PANS); PANS Pediatric Acute-Onset Neuropsychiatric Syndrome; Pediatric Acute-Onset Neuropsychiatric Syndrome

• Study Type: Observational
• Enrollment (Actual): 65

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Delafield, Wisconsin, United States, 53018
      • Brain Inflammation Collaborative

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Individuals will be recruited through social media and various online channels.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Economic and Quality of Life Impact of IVIG treatment	This survey asks respondents (and/or their parent/legal guardian) about aspects of IVIG treatment related to medical encounters, treatment access, financial impacts, insurance coverage, and the functional and emotional effects of PANS/PANDAS.	Baseline

Collaborators and Investigators

• Sponsor: Brain Inflammation Collaborative
• Collaborators: University of California, Los Angeles; Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2025
• Primary Completion (Actual): June 19, 2025
• Study Completion (Actual): June 19, 2025

Study Registration Dates

• First Submitted: February 5, 2025
• First Submitted That Met QC Criteria: February 7, 2025
• First Posted (Actual): February 10, 2025

Study Record Updates

• Last Update Posted (Estimated): September 12, 2025
• Last Update Submitted That Met QC Criteria: September 8, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Quality of Life; Observational; IVIG; Natural History Study; Patient-Reported Outcomes; PANS; PANDAS; Healthcare Resource Utilization; Immunomodulatory Treatments; Economic Impacts; Functional Impacts; Neuroinflammatory Disease; Decentralized Study
• Additional Relevant MeSH Terms: Nervous System Diseases; Pathologic Processes; Inflammation; Pathological Conditions, Signs and Symptoms; Neuroinflammatory Diseases; Pediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal infections; Pediatric acute-onset neuropsychiatric syndrome
• Other Study ID Numbers: BIC-2025-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Brain Inflammation Collaborative (BIC) Research Collaborators selected by BIC will have access to data reports from registry participants, in keeping with criteria of the specific collaborative investigation.
• IPD Sharing Time Frame: Data will be available to BIC Research Collaborators as long as the study remains active, and for 7 years thereafter upon request.
• IPD Sharing Access Criteria: BIC Research Collaborators will be selected based on mutual interest and on BIC's assessment that the Collaborator possesses knowledge, experience, ethics, and training that will benefit interpretation of registry data, and proposes a meritorious and feasible research project in line with BIC's Research Roadmap.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No