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.
Age 18 years or older and able to provide legally effective informed consent.
Located in a jurisdiction approved by the study team and applicable human-subjects oversight for remote participation.
Meets the definition for one of seven prespecified cohorts: healthy comparison; broad mitochondrial disease (excluding participants assigned to the dedicated POLG cohort); POLG-related disease; ME/CFS, Long COVID, POTS, or a related post-infectious or autonomic illness; cancer, cancer survivorship, or treatment-related fatigue; Lyme disease or post-treatment Lyme disease syndrome; or another neuromuscular or persistent energy-limiting condition.
Access to the required internet-capable device and ability to complete at least one approved home functional protocol.
Any condition identified by the medical monitor that makes grip or sit-to-stand testing unsafe.
Acute medical instability, recent hospitalization, or current symptoms requiring urgent evaluation.
Inability to consent or follow the protocol without an approved legally authorized representative process.
Planned participation in a conflicting interventional study during the observation window.
Community-dwelling adults who volunteer through approved digital outreach, disease-community or nonprofit outreach, an existing research-interest list, or authorized clinician and research-partner referrals. Participants must reside in an approved jurisdiction and qualify for one of seven prespecified cohorts. The anticipated enrollment is 400: 100 in the broad mitochondrial cohort and 50 in each of the other six cohorts, including the dedicated POLG cohort. These are planning targets rather than enrollment caps.
Cohort
Prospective
Mito Map Energy Score and Home Functional Assessments
Other interventionObservational measurement package completed at baseline and approximately every two weeks through week 12. It includes the canonical Mito Map Energy Score and protocolized home measures of objective function, including grip strength and five-times sit-to-stand when safe and feasible. Participants are not assigned treatment, and these measurements are not used for diagnosis or clinical decision-making.
7
Treatment groupsSee each treatment group below.
Within-participant association between canonical Energy Score and objective home function composite
Coefficient for within-person centered canonical Energy Score in a participant fixed-effects model of the participant-self-administered, unblinded objective home function composite, adjusted for centered elapsed week and locked measurement-condition covariates, with participant-cluster-robust sandwich standard errors. The anchor is algorithmically independent because it shares no inputs with the Energy Score; it is not independently administered or blinded.
Within-participant association between canonical Energy Score and full Measured Function Score
Fixed-effect coefficient for within-person centered canonical Energy Score in the longitudinal model of the locked Measured Function Score that includes fatigue. Interpretation will explicitly acknowledge shared symptom inputs and possible circularity.
Within-participant association between canonical Energy Score and grip strength
Fixed-effect coefficient for within-person centered canonical Energy Score in the longitudinal model of maximum valid grip force from three protocolized attempts. Grip force is natural-log transformed; device, hand, and measurement-condition covariates are recorded.
Within-participant association between canonical Energy Score and five-times sit-to-stand performance
Fixed-effect coefficient for within-person centered canonical Energy Score in the longitudinal model of natural-log five-times-sit-to-stand seconds, direction aligned so higher values indicate better performance.
Energy Score test-retest reliability during clinically stable intervals
Absolute-agreement single-measure ICC(A,1) from a two-way mixed-effects model and standard error of measurement for adjacent assessments with no acute infection, hospitalization or urgent visit, function-altering medication change in the prior 7 days, unusual exertion in the prior 48 hours, or major measurement-protocol deviation.
Between-participant association between mean Energy Score and mean objective home function
Association between each participant's mean canonical Energy Score and mean objective home function composite, reported separately from the primary within-person estimand.
Incremental prediction of the next objective functional assessment
Difference in root mean squared prediction error under participant-grouped 10-fold cross-validation between a model containing current objective function and elapsed time and a model that additionally contains current canonical Energy Score. This exploratory analysis does not establish prognosis or clinical utility.
Variation in the primary association across prespecified cohorts
Energy Score-by-cohort interaction estimates and cohort-specific coefficients with confidence intervals. The study is not powered for interaction detection; results are exploratory, and absence of significance will not be interpreted as equivalence between cohorts.
Quality-qualified longitudinal transition yield
Number and percentage of up to six adjacent scheduled assessment intervals per participant that qualify. Both assessments must occur within the prespecified visit windows and contain the canonical Energy Score, objective functional anchor, timestamps, and required completeness fields. Qualification describes analyzable longitudinal coverage and does not imply clinical change or causality.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
