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NCT Number: NCT04806620

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

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.

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Key information

Conditions

Post-Acute COVID-19 Syndrome ARFID Ankylosing Spondylitis (AS) Ankylosis Anorexia Nervosa Anxiety Disorders Arthritis Arthritis, Juvenile Arthritis, Psoriatic Autoimmune Diseases Autoimmune Diseases of the Nervous System Autoimmune Encephalitis Autonomic Nervous System Diseases Avoidant / Restrictive Food Intake Disorder Avoidant Restrictive Food Intake Disorder Axial Spondyloarthritis Bacterial Infections Bacterial Infections and Mycoses Basal Ganglia Diseases Behavior Behavioral Symptoms Bone Diseases Borrelia Infections Brain Diseases Brain Injuries Brain Injuries, Traumatic Bulimia Nervosa COVID-19 Cardiovascular Diseases Celiac Disease Celiac Disease in Children Central Nervous System Diseases Chronic Disease Chronic Lyme Disease Colitis Colitis, Ulcerative Collagen Diseases Colonic Diseases Combat Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Coronaviridae Infections Coronavirus Infections Craniocerebral Trauma Crohn Disease Crohn's Disease Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Depression Digestive System Diseases Disease Attributes Disorders of Excessive Somnolence Dysautonomia Dyssomnias Ehlers Danlos Syndrome Ehlers-Danlos Syndrome Encephalitis Encephalomyelitis Endometriosis Fatigue Fatigue Syndrome, Chronic Feeding and Eating Disorders Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fibromyalgia Fibromyalgia (FM) Gastroenteritis Gastrointestinal Diseases General Anxiety Disorder, Social Anxiety Disorder Generalized Anxiety Disorder Genetic Diseases, Inborn Genital Diseases Genital Diseases, Female Gram-Negative Bacterial Infections Gram-Positive Bacterial Infections Headache Disorders Headache Disorders, Primary Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Heredodegenerative Disorders, Nervous System Immune System Diseases Infections Inflammation Inflammatory Bowel Disease (IBD) Inflammatory Bowel Diseases Intestinal Diseases Joint Diseases Juvenile Rheumatoid Arthritis (JRA) Long COVID Lung Diseases Lupus Lyme Disease ME/CFS Malabsorption Syndromes Mast Cell Activation Disorders Mast Cell Activation Syndrome Mental Disorders Mental Fatigue Metabolic Diseases Migraine Disorders Migraines Mood Disorders Movement Disorders Multiple Sclerosis Muscular Diseases Musculoskeletal Diseases Myalgic Encephalomyelitis (ME) Myasthenia Gravis Myasthenia Gravis in Children Myasthenia Gravis, Generalized Narcolepsy Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Neurodegenerative Diseases Neurodevelopmental Disorders Neuroinflammatory Diseases Neurological Diseases or Conditions Neuromuscular Diseases Neuromuscular Junction Diseases Nidovirales Infections Nutritional and Metabolic Diseases Obsessive Compulsive Disorder (OCD) Obsessive-Compulsive Disorder Orthostatic Intolerance PANDAS POTS - Postural Orthostatic Tachycardia Syndrome PTSD - Post Traumatic Stress Disorder Paraneoplastic Syndromes Paraneoplastic Syndromes, Nervous System Pathologic Processes Pathological Conditions, Signs and Symptoms Pediatric Acute-onset Neuropsychiatric Syndrome (PANS) Pediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal infections Pediatric acute-onset neuropsychiatric syndrome Personal Satisfaction Phobia, Social Phobic Disorders Pneumonia Pneumonia, Viral Post-Infectious Disorders Post-Lyme Disease Syndrome Post-treatment Lyme Disease Syndrome Postural Orthostatic Tachycardia Syndrome Primary Dysautonomias Psoriasis Psoriatic Arthritis (PsA) Psychiatric Disorder Psychological Well-Being RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Rheumatic Arthritis Rheumatic Diseases Rheumatic Fever Signs and Symptoms Sjogren's Syndrome Skin Abnormalities Skin Diseases Skin Diseases, Genetic Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Sleep Disorders, Intrinsic Sleep Wake Disorders Spinal Diseases Spirochaetales Infections Spondylarthritis Spondylarthropathies Spondylitis Spondylitis, Ankylosing Streptococcal Infections Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Tic Disorders Tick-Borne Diseases Tourette Syndrome Tourette's Syndrome Trauma and Stressor Related Disorders Trauma, Nervous System Traumatic Brain Injury Ulcerative Colitis and Crohn's Disease Urogenital Diseases Vascular Diseases Vector Borne Diseases Virus Diseases Wounds and Injuries

Age range

2 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Demographics

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

    Record basic demographic information of our Registry population including: age, race, ethnicity, income, education, employment, marital status.

  2. Comorbitities

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

    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.

  3. Quality of Life and Functional Status

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

    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.

  4. Symptoms

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

    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.

Other outcomes

  1. Electronic Heath Record Linkage

    Time frame: 36 months

    Link EHR data to patient-reported outcomes in order to better identify neuroinflammation and neuroinflammatory conditions.

  2. Clinical Study Participation

    Time frame: 36 months

    Use the Unhide Platform to identify and invite eligible patients and controls to participate in clinical studies with academic, CRO, and pharmaceutical partners.

Study contacts

Contact information is provided by the study sponsor or research team.

Christina Moon

CONTACT

[email protected]

1-833-286-4433

Megan L Fitzgerald, PhD

CONTACT

[email protected]

1-833-286-4433

Sponsors and collaborators

Lead sponsor

Brain Inflammation Collaborative

Other

Collaborators

  • Care Evolution
  • Columbia University
  • Solve ME/CFS Initiative

Registry information

Official study title

Unhide® Project Also Known as The Unhide® Solve Together Unified Platform

Important dates

Study start
2023
Primary completion
2030
Study completion
2030
First posted
Mar 19, 2021
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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