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

January 20, 2026 updated by: Brain Inflammation Collaborative

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Healthy Controls
No intervention will be administered.
People with brain inflammation and related neuroinflammatory conditions
No intervention will be administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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

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.
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

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.
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

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Electronic Heath Record Linkage
Time Frame: 36 months
Link EHR data to patient-reported outcomes in order to better identify neuroinflammation and neuroinflammatory conditions.
36 months
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.
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brain Inflammation Collaborative

Collaborators

Columbia University
Solve ME/CFS Initiative
Care Evolution

Investigators

  • Principal Investigator: Megan L Fitzgerald, PhD, Brain Inflammation Collaborative

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 5, 2023

Primary Completion (Estimated)

June 30, 2030

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

March 17, 2021

First Submitted That Met QC Criteria

March 17, 2021

First Posted (Actual)

March 19, 2021

Study Record Updates

Last Update Posted (Actual)

January 22, 2026

Last Update Submitted That Met QC Criteria

January 20, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1 (Other Identifier: Mobile Health and Wellness Program)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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