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NotableLead sponsor: Solve ME/CFS Initiative to Brain Inflammation Collaborativev5Show 9 more changesShow less
Primary completion date: Jul 1, 2025 to Jun 30, 2030
Study completion date: Jul 1, 2025 to Dec 31, 2030
Eligibility criteria expanded, about 162 words
Secondary endpoints: details revised at 4 of 4 entries
Study description expanded, about 11 words
Study site revised
Collaborators expanded, about 7 words
Study title shortened, about 25 words
Study arms: 3 to 2
MinorStart date changed from estimate of Sep 12, 2023 to Jul 5, 2023
Study title expanded, about 23 words
v4
NotableStart date: May 1, 2020 to Sep 12, 2023v3Show 6 more changesShow less
Primary endpoints: 2 to 3
Primary and study completion dates: May 1, 2025 to Jul 1, 2025
Eligibility criteria shortened, about 8 words
Secondary endpoints: 5 to 4
Study description shortened, about 153 words
Study title expanded, about 9 words
NotableEnrollment target: 1500 to 10000v2Show 5 more changesShow less
Primary and study completion dates: Jan 1, 2022 to May 1, 2025
Start date: Jan 1, 2020 to May 1, 2020
Primary endpoints: 1 to 2
Secondary endpoints: 4 to 5
Study description expanded, about 161 words
MinorStudy First Submitted
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.