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

NCT04806620 | Recruiting

• 1 other identifier: 1
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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; ARFID; Rheumatic Arthritis; Juvenile Rheumatoid Arthritis (JRA); Psoriatic Arthritis (PsA); Ankylosing Spondylitis (AS); Autoimmune Encephalitis; Celiac Disease; Celiac Disease in Children; Chronic Lyme Disease; Post-treatment Lyme Disease Syndrome; Crohn's Disease; Dysautonomia; Anorexia Nervosa; Bulimia Nervosa; Avoidant / Restrictive Food Intake Disorder; Ehlers Danlos Syndrome; Endometriosis; Fibromyalgia (FM); Long COVID; Lupus; Migraines; Mast Cell Activation Syndrome; Multiple Sclerosis; Myalgic Encephalomyelitis (ME); Myasthenia Gravis, Generalized; Myasthenia Gravis in Children; Narcolepsy; Obsessive Compulsive Disorder (OCD); PANDAS; Pediatric Acute-onset Neuropsychiatric Syndrome (PANS); POTS - Postural Orthostatic Tachycardia Syndrome; General Anxiety Disorder, Social Anxiety Disorder; PTSD - Post Traumatic Stress Disorder; Psoriasis; Traumatic Brain Injury; Tourette's Syndrome; Inflammatory Bowel Disease (IBD); Autoimmune Diseases; Neurological Diseases or Conditions; Psychiatric Disorder; Sjogren's Syndrome; Ulcerative Colitis and Crohn's Disease

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

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  From Baseline through up to 10 years, with assessments approximately every 4-12 weeks

Secondary Outcomes (4)

• Demographics

  From Baseline through up to 10 years, with assessments approximately every 52 weeks

• Comorbitities

  From Baseline through up to 10 years, with assessments approximately every 4-12 weeks

• Quality of Life and Functional Status

  From Baseline through up to 10 years, with assessments approximately every 4-12 weeks

• Symptoms

  From Baseline through up to 10 years, with assessments approximately every 4-12 weeks

Other Outcomes (2)

• Electronic Heath Record Linkage

  36 months

• Clinical Study Participation

  36 months

Study Arms (2)

People with brain inflammation and related neuroinflammatory conditions

No intervention will be administered.

Healthy Controls

No intervention will be administered.

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Brain Inflammation Collaborative: lead
• Care Evolution: collaborator
• Solve ME/CFS Initiative: collaborator
• Columbia University: collaborator

Study Sites (1)

Brain Inflammation Collaborative

Delafield, Wisconsin, 53018, United States

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Fatigue Syndrome, Chronic; Rheumatic Fever; Arthritis, Juvenile; Arthritis, Psoriatic; Spondylitis, Ankylosing; Autoimmune Diseases of the Nervous System; Celiac Disease; Post-Lyme Disease Syndrome; Crohn Disease; Autonomic Nervous System Diseases; Anorexia Nervosa; Bulimia Nervosa; Avoidant Restrictive Food Intake Disorder; Ehlers-Danlos Syndrome; Endometriosis; Fibromyalgia; Migraine Disorders; Mast Cell Activation Syndrome; Multiple Sclerosis; Myasthenia Gravis; Narcolepsy; Obsessive-Compulsive Disorder; Pediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal infections; Pediatric acute-onset neuropsychiatric syndrome; Postural Orthostatic Tachycardia Syndrome; Generalized Anxiety Disorder; Phobia, Social; Combat Disorders; Psoriasis; Brain Injuries, Traumatic; Tourette Syndrome; Inflammatory Bowel Diseases; Autoimmune Diseases; Mental Disorders; Colitis, Ulcerative; Neuroinflammatory Diseases; Encephalitis; Mood Disorders; Anxiety Disorders; Depression; Stress Disorders, Post-Traumatic; Fatigue; Mental Fatigue; Psychological Well-Being

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Nervous System Diseases; Neuromuscular Diseases; Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Arthritis; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Immune System Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Skin Diseases, Papulosquamous; Skin Diseases; Axial Spondyloarthritis; Ankylosis; Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Lyme Disease; Gram-Negative Bacterial Infections; Borrelia Infections; Spirochaetales Infections; Tick-Borne Diseases; Vector Borne Diseases; Gastroenteritis; Feeding and Eating Disorders; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Genetic Diseases, Inborn; Collagen Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Mast Cell Activation Disorders; Demyelinating Autoimmune Diseases, CNS; Demyelinating Diseases; Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Neurodegenerative Diseases; Neuromuscular Junction Diseases; Disorders of Excessive Somnolence; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Orthostatic Intolerance; Primary Dysautonomias; Phobic Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Basal Ganglia Diseases; Tic Disorders; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodevelopmental Disorders; Colitis; Colonic Diseases; Inflammation; Behavioral Symptoms; Behavior; Signs and Symptoms; Personal Satisfaction

Study Officials

• Megan L Fitzgerald, PhD

  Brain Inflammation Collaborative

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Megan L Fitzgerald, PhD

CONTACT

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

Christina Moon

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2021
• First Posted: March 19, 2021
• Study Start: July 5, 2023
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, 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.

Locations

US (1)