ClinicalTrials.gov record NCT04806620

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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

Unhide® Project Also Known as The Unhide® Solve Together Unified Platform

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
Healthy volunteersAcceptedPeople who do not have the condition being studied who are allowed to take part. Some studies include both people with the condition and healthy volunteers; others may enrol only healthy volunteers.
Age2 years old and older
SexAll
LocationUnited States
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This is a long-term, observational registry that collects self-reported health information, symptom diaries, and wearable device data through a mobile/web app. It follows participants for up to 10 years to build a secure dataset for research into brain inflammation and related conditions. Participants include people in the U.S. aged 2 years and older with neuroinflammatory or related diagnoses and unaffected (healthy) individuals.

What it is studying. Whether a large, long-term collection of patient-reported health, symptom, biometric, and wearable data can be used to describe disease patterns, identify subtypes, and enable research into causes, risk factors, diagnostics, and potential treatments for neuroinflammatory and related conditions.

What the researchers hope to learn. Create a secure, long-term dataset to: 1) characterize clinical features and progression of brain inflammation and related disorders; 2) identify disease subtypes and common comorbidities; 3) uncover possible causes and risk factors; and 4) support development of diagnostic tests and future research into treatments.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion 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

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Show the detailed description from the registry

The unhide® Project is sponsored by the Brain Inflammation Collaborative (BIC), a nonprofit organization dedicated to advancing understanding, diagnosis, and treatment of neuroinflammatory illness. This study will create a secure, long-term repository of demographic, health, lifestyle, biometric, and symptom data from individuals in the United States with brain inflammation and related conditions, as well as unaffected individuals. Data will be collected remotely through MyDataHelps™ by Care Evolution (rebranded as unhide®), a secure mobile and web-based platform enabling eConsent, survey completion, health record linkage, and optional symptom/activity tracking. Eligible participants are U.S. residents aged 2 years and older, including both self-identified and physician-diagnosed individuals with infection-associated, autoimmune, neuroimmune, inflammatory gastrointestinal, and behavioral/mood disorders, as well as "healthy" individuals. There are minimal exclusion criteria: individuals living outside the U.S., wards of the state, and those with decisional impairment are ineligible. Pregnant women may participate, and prior or concurrent participation in other research studies is permitted. The study will follow participants for 10 or more years, collecting self-reported health information, comorbidities, medical history, biometrics (e.g., heart rate, sleep, activity), and symptom data to generate comprehensive longitudinal health profiles. This data resource aims to accelerate translational research, identify disease subtypes, uncover causes and risk factors, support the development of diagnostic tests and treatments, and improve outcomes for individuals affected by neuroinflammation.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

You would e‑consent and use the MyDataHelps™ (unhide®) app to complete regular surveys and symptom diaries for up to 10 years, with assessments approximately every 4–12 weeks. You may opt to link medical records, use wearable devices for passive data collection (steps, sleep, heart‑rate measures), and complete standardized symptom and quality‑of‑life questionnaires (some logs can be entered daily). All activities are collected remotely through the app; study staff may contact participants and some may be invited to optional future studies.

How the study is structured. A prospective, remote, app-based observational registry (no treatments assigned). Participants provide eConsent, complete surveys and symptom diaries at regular intervals, may link health records, and can optionally connect wearable devices for passive data collection. The study follows people for 10 or more years to build longitudinal health profiles.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

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Important dates

Study start
Jul 5, 2023
Primary completion
Jun 30, 2030 (estimated)
Study completion
Dec 31, 2030 (estimated)
Target enrollment
10000 participants (estimated)
Last updated on registry
Jan 22, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Brain Inflammation Collaborative
Collaborators
  • Solve ME/CFS Initiative
  • Care Evolution
  • Columbia University

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

exclusion criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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