Post-Acute COVID-19 SyndromeNCT04806620
Unhide® Project: A Digital Health Platform to Collect Lifestyle Data for Brain Inflammation Research
An observational study of Post-Acute COVID-19 Syndrome and ME/CFS, run by Brain Inflammation Collaborative at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post-Acute COVID-19 Syndrome, ME/CFS, Rheumatic Arthritis
- How many people
- 10,000 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jul 2023to 31 Dec 2030
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 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:
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Brain Inflammation Collaborative
Delafield, Wisconsin, 53018
Christy Jagdfeld, CPA, 833-286-4433, help@braininflammationcollaborative.org
Christina Moon, 833-286-4433, help@braininflammationcollaborative.org
About this study
Official title: Unhide® Project Also Known as The Unhide® Solve Together Unified Platform
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.
Read the 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.
- Conditions
- Post-Acute COVID-19 Syndrome, ME/CFS, Rheumatic Arthritis, Juvenile Rheumatoid Arthritis (JRA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS)
- Keywords
- Long COVID, Myalgic Encephalomyelitis, Chronic Fatigue Syndrome, Longitudinal Natural History Study, Observational, Neuroinflammatory Disease, Brain inflammation, Neuroinflammatory disorders, PANS/PANDAS, Autoimmune encephalitis, ME/CFS, Dysautonomia / POTS, Multiple sclerosis, Autoimmune disease, Inflammatory bowel disease (Crohn's, ulcerative colitis), Celiac disease, Migraines, Mood disorders (anxiety, depression, bipolar, PTSD, OCD), Mobile health app, Patient registry
- Medical subject headings
- Post-Acute COVID-19 Syndrome, Fatigue Syndrome, Chronic, Rheumatic Fever, Arthritis, Juvenile, Arthritis, Psoriatic, Spondylitis, Ankylosing, Autoimmune Diseases of the Nervous System, Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| People with brain inflammation and related neuroinflammatory conditions | No intervention will be administered. | |
| Healthy Controls | No intervention will be administered. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: From Baseline through up to 10 years, with assessments approximately every 4-12 weeks
Secondary outcomes (4)
Demographics
Record basic demographic information of our Registry population including: age, race, ethnicity, income, education, employment, marital status.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From Baseline through up to 10 years, with assessments approximately every 4-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start5 Jul 2023
- Primary completion30 Jun 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-Acute COVID-19 SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Brain Inflammation Collaborative
- Sponsor type
- University, hospital or other
- Collaborators
- Solve ME/CFS Initiative, Care Evolution, Columbia University
- Responsible party
- Sponsor
- Investigators
- Megan L Fitzgerald, PhD, Principal investigator, Brain Inflammation Collaborative
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04806620
- Sponsor's protocol ID
- 1
- Status last verified
- Jan 2026
- First submitted
- 17 Mar 2021
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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.
PubMed 35816681
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unhide® Project Also Known as The Unhide® Solve Together Unified Platform
- ClinicalTrials.gov ID
- NCT04806620
- Acronym / sponsor ID
- 1
- Conditions
- Post-Acute COVID-19 Syndrome, ME/CFS, Rheumatic Arthritis, Juvenile Rheumatoid Arthritis (JRA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS)
- Keywords
- Long COVID, Myalgic Encephalomyelitis, Chronic Fatigue Syndrome, Longitudinal Natural History Study, Observational, Neuroinflammatory Disease, Brain inflammation, Neuroinflammatory disorders
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Brain Inflammation CollaborativeUniversity, hospital or other
- Collaborators
- Solve ME/CFS Initiative, Care Evolution, Columbia University
- Study start
- 5 Jul 2023 (actual)
- Primary completion
- 30 Jun 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 19 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| People with brain inflammation and related neuroinflammatory conditions | – | –No intervention will be administered. |
| Healthy Controls | – | –No intervention will be administered. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This is a study of individuals with brain inflammation and healthy controls.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Phenotypic data collection
Time frame: From Baseline through up to 10 years, with assessments approximately every 4-12 weeks
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.
Subtyping
Time frame: From Baseline through up to 10 years, with assessments approximately every 4-12 weeks
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.
Passive data collection
Time frame: From Baseline through up to 10 years, with assessments approximately every 4-12 weeks
Collect data from wearables that allow us to track step counts, heart rate variability and other indicators without the burden of participant data entry.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Derived from this study: PubMed 35816681Ramiller 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Megan L Fitzgerald, PhD principal investigator
Brain Inflammation Collaborative
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-Acute COVID-19 Syndrome and ME/CFS, run by Brain Inflammation Collaborative at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Megan L Fitzgerald, PhD (1-833-286-4433, help@braininflammationcollaborative.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phenotypic data collection (time frame: From Baseline through up to 10 years, with assessments approximately every 4-12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04806620, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.