RecruitingNot Applicable

Unhide® Project: A Digital Health Platform to Collect Lifestyle Data for Brain Inflammation Research

United States10,000 participantsStarted 2023-07-05

Plain-language 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.

Who can participate

Age range

2 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial seems to be about collecting lifestyle and health data through a digital platform rather than testing a treatment — does that mean there's no experimental therapy involved, and what exactly would I be doing if I participated?
2Since this study covers a wide range of conditions including Long COVID, ME/CFS, and autoimmune diseases, how confident are you that my specific diagnosis is a good fit for what the researchers are trying to learn about brain inflammation?
3The trial mentions 'passive data collection' — can you help me understand what kinds of data would be collected from my devices or daily life, and are there any privacy or data-sharing concerns I should be aware of before signing up?
4Because this is a data-collection study rather than a treatment trial, would participating in it conflict with or delay any standard treatments or other clinical trials that might actually address my symptoms?
5Given that the goal is to 'subtype' conditions like mine, what might the researchers or I realistically learn from my participation, and is there any chance the findings could directly influence my own care down the line?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Phenotypic data collection

Timeframe: From Baseline through up to 10 years, with assessments approximately every 4-12 weeks

Subtyping

Timeframe: From Baseline through up to 10 years, with assessments approximately every 4-12 weeks

Passive data collection

Timeframe: From Baseline through up to 10 years, with assessments approximately every 4-12 weeks

Trial details

NCT IDNCT04806620

SponsorBrain Inflammation Collaborative

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2030-06-30

Contact for this trial

Megan L Fitzgerald, PhD

1-833-286-4433 help@braininflammationcollaborative.org

View on ClinicalTrials.gov More Post-Acute COVID-19 Syndrome trials

Plain-language summary

Who can participate

Age range

2 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Phenotypic data collection

Timeframe: From Baseline through up to 10 years, with assessments approximately every 4-12 weeks

Subtyping

Timeframe: From Baseline through up to 10 years, with assessments approximately every 4-12 weeks

Passive data collection

Timeframe: From Baseline through up to 10 years, with assessments approximately every 4-12 weeks