An observational study in Post-Acute COVID-19 Syndrome, ME/CFS and Rheumatic Arthritis, sponsored by Brain Inflammation Collaborative. Recruiting at 1 site in United States. Open to participants aged 2 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-22.
Sponsored by Brain Inflammation Collaborative · Observational
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.
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.
604 studies on the registry are indexed under Post-Acute COVID-19 Syndrome; 201 are open to participants now.
This study's planned enrollment of 10,000 is above the median of 150 across 173 observational studies indexed under Post-Acute COVID-19 Syndrome.
Browse Post-Acute COVID-19 Syndrome studies →Brain Inflammation Collaborative is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
This is a study of individuals with brain inflammation and healthy controls.
Participants may be either self-diagnosed, or diagnosed by a physician with the following conditions:
Inflammatory gastrointestinal conditions such as Crohn's Disease, Celiac Disease, and ulcerative colitis.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
No intervention will be administered.
No intervention will be administered.
Phenotypic data collection
Collect, collate, clean, and analyze a large, well-characterized longitudinal dataset to investigate causes, disease progression, and potential treatments for complex chronic conditions, including infection-associated chronic diseases such as ME/CFS, Long COVID, PANS/PANDAS, autoimmune diseases, and neuroimmune disorders characterized at least in part by symptoms of neuroinflammation, including fatigue, brain fog, mood and behavioral changes, or other central or peripheral neurological symptoms.
Time frame: From Baseline through up to 10 years, with assessments approximately every 4-12 weeks
Subtyping
Use the patient reported outcomes to identify brain inflammation and other neuroinflammatory disease subtypes. * DePaul Symptom Questionnaire - Short Form (DSQ-SF): A survey measuring frequency and severity of symptoms common in ME/CFS and related conditions. Collected at baseline and quarterly thereafter. * COMPASS-31:A 31-item questionnaire survey autonomic symptoms including orthostatic intolerance, gastrointestinal, and vasomotor symptoms. Collected starting 1 month after baseline, every 6 months thereafter. * Beighton Questionnaire: A quick screening tool for generalized joint hypermobility, assessing flexibility. Collected starting 1 month after baseline, every 6 months thereafter.
Time frame: From Baseline through up to 10 years, with assessments approximately every 4-12 weeks
Passive data collection
Collect data from wearables that allow us to track step counts, heart rate variability and other indicators without the burden of participant data entry.
Time frame: From Baseline through up to 10 years, with assessments approximately every 4-12 weeks
Demographics
Record basic demographic information of our Registry population including: age, race, ethnicity, income, education, employment, marital status.
Time frame: From Baseline through up to 10 years, with assessments approximately every 52 weeks
Comorbitities
Catalog common comorbidities in our registry population. Participants provide information on diagnosed conditions, age of onset, and whether the condition is still active. Their conditions list can be updated over time. * Medical Conditions History: A survey on participants' current and past diagnoses. Collected at baseline and updated every 6 months. * Family Health History: A survey on health conditions of biological relatives. Collected starting 1 month after baseline; responses may be updated by participants at any time.
Time frame: From Baseline through up to 10 years, with assessments approximately every 4-12 weeks
Quality of Life and Functional Status
Quality of life and daily functioning will be assessed using standardized surveys. These include (but not limited to): * Short Form-36 (SF-36): A 36-item survey assessing overall health-related quality of life across eight domains, including physical functioning, pain, vitality, and mental health. Administered at baseline and quarterly thereafter. * Self-reported Karnofsky Performance Scale: A scale measuring participants' ability to perform daily activities and independence. Administered 1 month after baseline and annually thereafter. * FUNCAP-27 (Functional Capacity): A 27-item survey evaluating functional capacity in daily tasks and physical activities relevant to patient well-being. Administered 1 month after baseline and quarterly thereafter.
Time frame: From Baseline through up to 10 years, with assessments approximately every 4-12 weeks
Symptoms
We aim to catalogue the common symptoms of brain inflammation and analyze the data for symptom-based phenotypes. We administer surveys to assess the frequency and severity of symptoms (including neuroinflammatory, behavioral, fatigue, etc.) over time and provide access to a mobile app so participants can log data on their symptoms as often as daily. * Symptom Log: Collected continuously via mobile application, with optional daily entry. * Fatigue Severity Scale (FSS): A 9-item scale assessing the impact and severity of fatigue on daily functioning and quality of life. Collected starting 1 month after baseline, then quarterly. * GAD-7: A 7-item survey assessing the severity of generalized anxiety symptoms over the past two weeks. Collected at baseline and quarterly thereafter. * Brain Fog Questionnaire: A survey measuring cognitive symptoms such as memory and concentration. Currently in development.
Time frame: From Baseline through up to 10 years, with assessments approximately every 4-12 weeks
Electronic Heath Record Linkage
Link EHR data to patient-reported outcomes in order to better identify neuroinflammation and neuroinflammatory conditions.
Time frame: 36 months
Clinical Study Participation
Use the Unhide Platform to identify and invite eligible patients and controls to participate in clinical studies with academic, CRO, and pharmaceutical partners.
Time frame: 36 months
Plan to share: Yes — BIC Research Collaborators selected by the Brain Inflammation Collaborative will have access to data reports and biosamples from registry participants, in keeping with criteria of the specific collaborative investigation.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Data will be available to BIC Research Collaborators as long as the study remains active, and for a period thereafter to be determined.
Access criteria: BIC Research Collaborators will be selected based on mutual interest and on BIC's assessment that the Collaborator possesses knowledge, experience, and training that will benefit interpretation of registry data, and proposes a meritorious and feasible research project in line with BIC's research goals.
Started Jul 2023 (actual). Primary completion is estimated for Jun 2030, 83 months after the start.
Of 98 non-industry observational studies under Post-Acute COVID-19 Syndrome, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 39. This study's planned 83 months is above that.
Counting every sponsor, half of 105 studies reached it within 27 months; a quarter within 14 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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