PANDASNCT06818656
The Unhide™ Project: Economic Impact Study of IVIG Treatment for PANS
An observational study of PANDAS and PANS, run by Brain Inflammation Collaborative at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 89 years
- Conditions the study is for
- PANDAS, PANS, PANS Pediatric Acute-Onset Neuropsychiatric Syndrome
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2025to 19 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 89 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Individuals will be recruited through social media and various online channels.
Who may be able to join
- 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).
Who cannot join
- Ward of state
- Failure to meet inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Brain Inflammation Collaborative
Delafield, Wisconsin, 53018
About this study
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.
Read more
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
- 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
- Medical subject headings
- Pediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal infections, Pediatric acute-onset neuropsychiatric syndrome, Neuroinflammatory Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start1 Mar 2025
- Primary completion19 Jun 2025
- Study completion19 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PANDASStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brain Inflammation Collaborative
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University, University of California, Los Angeles
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06818656
- Sponsor's protocol ID
- BIC-2025-01
- Status last verified
- Sep 2025
- First submitted
- 5 Feb 2025
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Unhide™ Project: Economic Impact Study of IVIG Treatment for PANS
- ClinicalTrials.gov ID
- NCT06818656
- Acronym / sponsor ID
- BIC-2025-01
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Brain Inflammation CollaborativeUniversity, hospital or other
- Collaborators
- Stanford University, University of California, Los Angeles
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 19 Jun 2025 (actual)
- Study completion
- 19 Jun 2025 (actual)
- First posted
- 10 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 2 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Individuals will be recruited through social media and various online channels.
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (2 listed)
- Ward of state
- Failure to meet inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Economic and Quality of Life Impact of IVIG treatment
Time frame: Baseline
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Individual participant dataSharing planned: Yes. 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.
Related trials for PANDAS
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Post-Acute COVID-19 Syndrome, ME/CFS
RecruitingObservational study
Neurobiologic, Immunologic, and Rheumatologic Markers in Youth With PANS
Pediatric Acute-Onset Neuropsychiatric Syndrome, Pediatric Autoimmune Neuropsychiatric Disorders Associated With Streptococcal Infections
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PANDAS and PANS, run by Brain Inflammation Collaborative at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Economic and Quality of Life Impact of IVIG treatment (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.