NCT04806620 Unhide® Project: A Digital Health Platform to Collect Lifestyle Data for Brain Inflammation Research
| NCT ID | NCT04806620 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Brain Inflammation Collaborative |
| Condition | Post-Acute COVID-19 Syndrome |
| Study Type | OBSERVATIONAL |
| Enrollment | 10,000 participants |
| Start Date | 2023-07-05 |
| Primary Completion | 2030-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 10,000 participants in total. It began in 2023-07-05 with a primary completion date of 2030-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The unhide® Project is a non-interventional, longitudinal research study designed to establish a secure data repository of demographic, health, and lifestyle information from individuals with brain inflammation and related neuroinflammatory conditions. Participants in the United States aged 2 years and older will provide self-reported health data, biometrics, and symptom diaries through the MyDataHelps™ app (branded as unhide® for this study). The goal is to create comprehensive longitudinal profiles to facilitate research into disease subtypes, causes, diagnostics, and potential treatments, as well as to identify potential participants for future optional studies. "Healthy" individuals without brain inflammation are also eligible to participate. The digital health research platform used in this study was originally developed and designed by Solve M.E and was called SolveTogether. The Brain Inflammation Collaborative (BIC) expanded upon Solve M.E.'s work to include related diagnoses, pediatric participants, enhance symptom tracking, and more. BIC and Solve M.E. combined Solve Together and unhide®, to create The unhide® Solve Together Unified Platform in 2025.
Eligibility Criteria
Participants may be either self-diagnosed, or diagnosed by a physician with the following conditions: * Infection-associated chronic conditions such as Long COVID, chronic Lyme, myalgic encephalomyelitis (ME/CFS), and post-acute neuropsychiatric syndrome (PANS/PANDAS). * Neuroimmune, developmental, autonomic, and neurological conditions like migraines, dysautonomia, POTS, multiple sclerosis, and autism spectrum disorder. * Autoimmune diseases such as Lupus, Sjogren's Disease, rheumatoid arthritis, myasthenia gravis, ankylosing spondylitis, and related autoimmune conditions. Inflammatory gastrointestinal conditions such as Crohn's Disease, Celiac Disease, and ulcerative colitis. * Behavioral and mood disorders such as anxiety, depression, bipolar disorder, PTSD, eating disorders, OCD, and other related conditions. * "Healthy" people (without brain inflammation), including unaffected individuals, unaffected individuals in the same household, and unaffected individuals who are married to relatives and family members. * Have consistent internet access and a cell phone, tablet, or PC since this is an online or app-based platform that requires entering data and completing surveys. * Currently live in the United States * Be able to participate in English (stay tuned for updates about the Spanish language version) * Be willing to share symptom and health data through the platform
Contact & Investigator
Megan L Fitzgerald, PhD
PRINCIPAL INVESTIGATOR
Brain Inflammation Collaborative
Frequently Asked Questions
Who can join the NCT04806620 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, studying Post-Acute COVID-19 Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04806620 currently recruiting?
Yes, NCT04806620 is actively recruiting participants. Contact the research team at help@braininflammationcollaborative.org for enrollment information.
Where is the NCT04806620 trial being conducted?
This trial is being conducted at Delafield, United States.
Who is sponsoring the NCT04806620 clinical trial?
NCT04806620 is sponsored by Brain Inflammation Collaborative. The principal investigator is Megan L Fitzgerald, PhD at Brain Inflammation Collaborative. The trial plans to enroll 10,000 participants.
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