Health TrialsbyHealthPanel

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

ConditionsPost-Acute COVID-19 SyndromeME/CFSRheumatic ArthritisJuvenile Rheumatoid Arthritis (JRA)Psoriatic Arthritis (PsA)Ankylosing Spondylitis (AS)Autoimmune EncephalitisCeliac DiseaseCeliac Disease in ChildrenChronic Lyme DiseasePost-treatment Lyme Disease SyndromeCrohn's DiseaseDysautonomiaAnorexia NervosaBulimia NervosaARFIDAvoidant / Restrictive Food Intake DisorderEhlers Danlos SyndromeEndometriosisFibromyalgia (FM)Long COVIDLupusMigrainesMast Cell Activation SyndromeMultiple SclerosisMyalgic Encephalomyelitis (ME)Myasthenia Gravis, GeneralizedMyasthenia Gravis in ChildrenNarcolepsyObsessive Compulsive Disorder (OCD)PANDASPediatric Acute-onset Neuropsychiatric Syndrome (PANS)POTS - Postural Orthostatic Tachycardia SyndromeGeneral Anxiety Disorder, Social Anxiety DisorderPTSD - Post Traumatic Stress DisorderPsoriasisTraumatic Brain InjuryTourette's SyndromeInflammatory Bowel Disease (IBD)Autoimmune DiseasesNeurological Diseases or ConditionsPsychiatric DisorderSjogren's SyndromeUlcerative Colitis and Crohn's Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2+
SponsorBrain Inflammation Collaborative

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Behavioral and mood disorders such as anxiety, depression, bipolar disorder, PTSD, eating disorders, OCD, and other related conditions.

Disqualifiers

None

Trial population

This is a study of individuals with brain inflammation and healthy controls.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

10,000 Participants
are grouped into 2 trial groups
Group A: People with brain inflammation and related neuroinflammatory conditions
Group B: Healthy Controls

Trial outcomes

Primary outcomes

1

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
2

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
3

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

1

Electronic Heath Record Linkage

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

Time frame
36 months
2

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Brain Inflammation Collaborative

Lead sponsor

Solve ME/CFS Initiative

Collaborator

Care Evolution

Collaborator

Columbia University

Collaborator

Source ClinicalTrials.gov
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