RECRUITING

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

Conditions

Post-Acute COVID-19 SyndromeME/CFSRheumatic ArthritisJuvenile Rheumatoid Arthritis (JRA)Psoriatic Arthritis (PsA)Ankylosing Spondylitis (AS)Autoimmune EncephalitisBipolar Disorder (BPD)Celiac DiseaseCeliac Disease in ChildrenChronic Lyme DiseasePost-treatment Lyme Disease SyndromeCrohn's DiseaseDysautonomiaAnorexia NervosaBulimia NervosaARFIDAvoidant / Restrictive Food Intake DisorderEhlers Danlos SyndromeEndometriosisFibromyalgia (FM)Long COVIDLupusMajor DepressionMigrainesMast 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 DiseaseMyalgic EncephalomyelitisChronic Fatigue SyndromeLongitudinal Natural History StudyObservationalNeuroinflammatory DiseaseBrain inflammationNeuroinflammatory disordersPANS/PANDASDysautonomia / POTSAutoimmune diseaseInflammatory bowel disease (Crohn's, ulcerative colitis)Mood disorders (anxiety, depression, bipolar, PTSD, OCD)Mobile health appPatient registryWearable devicesFatiguePost-exertional malaiseBrain FogMental health

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-07-05
Study Completion:2030-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04806620

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.

Ages Eligible for Study:2 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Megan L Fitzgerald, PhD
CONTACT
1-833-286-4433
megan@braininflammation.org
Christina Moon
CONTACT
1-833-286-4433
christina@braininflammation.org

Principal Investigator

Megan L Fitzgerald, PhD
PRINCIPAL_INVESTIGATOR
Brain Inflammation Collaborative

Study Locations (Sites)

Brain Inflammation Collaborative
Delafield, Wisconsin, 53018
United States

Collaborators and Investigators

Sponsor: Brain Inflammation Collaborative

  • Megan L Fitzgerald, PhD, PRINCIPAL_INVESTIGATOR, Brain Inflammation Collaborative

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 Registration Dates

Study Start Date2023-07-05
Study Completion Date2030-12-31

Study Record Updates

Study Start Date2023-07-05
Study Completion Date2030-12-31

Terms related to this study

Keywords Provided by Researchers

  • 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

Additional Relevant MeSH Terms

  • Post-Acute COVID-19 Syndrome
  • ME/CFS
  • Rheumatic Arthritis
  • Juvenile Rheumatoid Arthritis (JRA)
  • Psoriatic Arthritis (PsA)
  • Ankylosing Spondylitis (AS)
  • Autoimmune Encephalitis
  • Bipolar Disorder (BPD)
  • Celiac Disease
  • Celiac Disease in Children
  • Chronic Lyme Disease
  • Post-treatment Lyme Disease Syndrome
  • Crohn's Disease
  • Dysautonomia
  • Anorexia Nervosa
  • Bulimia Nervosa
  • ARFID
  • Avoidant / Restrictive Food Intake Disorder
  • Ehlers Danlos Syndrome
  • Endometriosis
  • Fibromyalgia (FM)
  • Long COVID
  • Lupus
  • Major Depression
  • 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