Clinical Research Directory

The Precision Mito- Mito Map COMPASS Study

Mito Map is a research tool that produces an Energy Score from information provided by a participant. This remote observational study has an initial enrollment target of 400 adults across seven prespecified cohorts: healthy comparison participants; broad mitochondrial disease; POLG-related disease; post-infectious or autonomic illness; Lyme disease or post-treatment Lyme disease syndrome; cancer or cancer-survivorship related fatigue; and other neuromuscular or persistent energy-limiting conditions. The broad mitochondrial cohort has an initial target of 100 participants, and each other cohort has an initial target of 50 participants. These are planning targets rather than caps. Participants complete a baseline assessment and repeated assessments about every two weeks for 12 weeks. Routine activity is designed to take about 5-10 minutes per week, although screening, consent, baseline setup, troubleshooting, or safety follow-up may take longer. Assessments include the Energy Score and protocolized home measures of physical function such as grip strength and five-times sit-to-stand performance, with an approved alternative when grip testing is unsuitable. Participants assigned to grip testing receive a study-provided hand-grip dynamometer at no cost. Optional compatible wearable data may be collected continuously when authorized and technically available. The study does not assign treatment, and research scores will not be used to make clinical decisions. The primary hypothesis is that, within the same participant, higher-than-usual Energy Score values will be associated with better-than-usual objective functional performance at matched assessments. Cohort comparisons, including POLG-specific analyses, are exploratory. A separately consented subset may use a study-provided Flic button to create timestamped symptom, context, or intervention markers with optional follow-up confirmation. The device module is not continuously monitored, does not assign treatment, and is not an emergency service.