Unhide® Project: A Digital Health Platform to Collect Lifestyle Data for Brain Inflammation Research
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Post-Acute COVID-19 Syndrome, ME/CFS, Rheumatic Arthritis, Juvenile Rheumatoid Arthritis (JRA). Basic parameters: from 2 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Unhide® Project Also Known as The Unhide® Solve Together Unified Platform
Overview
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.
Detailed description
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.
Primary outcome measures
- Phenotypic data collection [Time frame: From Baseline through up to 10 years, with assessments approximately every 4-12 weeks]
- Subtyping [Time frame: From Baseline through up to 10 years, with assessments approximately every 4-12 weeks]
- Passive data collection [Time frame: From Baseline through up to 10 years, with assessments approximately every 4-12 weeks]
Secondary outcome measures (4)
- Demographics [Time frame: From Baseline through up to 10 years, with assessments approximately every 52 weeks]
- Comorbitities [Time frame: From Baseline through up to 10 years, with assessments approximately every 4-12 weeks]
- Quality of Life and Functional Status [Time frame: From Baseline through up to 10 years, with assessments approximately every 4-12 weeks]
- Symptoms [Time frame: From Baseline through up to 10 years, with assessments approximately every 4-12 weeks]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Brain Inflammation Collaborative — Delafield
Publications
- Ramiller A, Mudie K, Seibert E, Whittaker S. The Facilitation of Clinical and Therapeutic Discoveries in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome and Related Diseases: Protocol for the You + ME Registry Research Platform. JMIR Res Protoc. 2022 Aug 10;11(8):e36798. doi: 10.2196/36798. PMID 35816681
Identifiers
NCT: NCT04806620 · 1