Recruiting

Observational Study

Sponsor:

Brain Inflammation Collaborative

Code:

NCT04806620

Conditions

Post-Acute COVID-19 Syndrome

ME/CFS

Rheumatic Arthritis

Juvenile Rheumatoid Arthritis (JRA)

Psoriatic Arthritis (PsA)

Eligibility Criteria

Sex: All

Age: 2+

Healthy Volunteers: Accepted

Study Details

Brief 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.

Conditions

Post-Acute COVID-19 Syndrome

ME/CFS

Rheumatic Arthritis

Juvenile Rheumatoid Arthritis (JRA)

Psoriatic Arthritis (PsA)

Study ID

NCT04806620

Start date

Jul 5, 2023

Status verified date

Jan, 2026

Completion date

Dec 31, 2030

Anticipated

Primary completion date

Jun 30, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2+

Healthy Volunteers: Accepted

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 Design

Enrollment

10000 participants

Anticipated

Interventions and Outcome Measures

Arms

People with brain inflammation and related neuroinflammatory conditions

No intervention will be administered.

Healthy Controls

No intervention will be administered.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Megan L Fitzgerald, PhD

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

Christina Moon

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

Locations

Brain Inflammation Collaborative

Recruiting

Delafield, Wisconsin, United States, 53018

Contacts

Christy Jagdfeld, CPA

833-286-4433help@braininflammationcollaborative.org

Christina Moon

833-286-4433help@braininflammationcollaborative.org

More Information

Sponsor

Brain Inflammation Collaborative

Last update posted

Jan 22, 2026

Last verified

Jan, 2026

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
  • Wearable devices
  • Fatigue
  • Post-exertional malaise
  • Brain Fog
  • Mental health

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-25. This information was provided to ClinicalTrials.gov by Brain Inflammation Collaborative on 2026-01-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.