Tracking Energy Levels in People With Mitochondrial Disease and Other Fatiguing Conditions
Follows adults with mitochondrial disease and other fatigue conditions using an energy score.
Key facts
- Who runs it
- AI Agent Vault, Inc. d/b/a Precision Mito
- Where
- Fort Myers, United StatesSee the site
- Trial code
- Registry title
- The Precision Mito- Mito Map COMPASS Study
- Status
- Not yet recruiting
- People taking part
- 400 people, planned
- Started
- 1 Nov 2026
- Expected to end
- 1 Nov 2029
- Type of study
- Observational, 7 groups
- Treatments tested
- Mito Map Energy Score and Home Functional Assessments
- Record updated
- 2 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults in seven groups: healthy volunteers, people with mitochondrial disease or POLG-related disease, people with long-lasting fatigue after infection or cancer, Lyme disease, or other muscle or low-energy conditions. It is a remote study with no treatment.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Mitochondrial disease (broad or POLG-related), ME/CFS, Long COVID, POTS or a similar post-infectious or autonomic illness, cancer or cancer-related fatigue, Lyme disease or post-treatment Lyme disease syndrome, or another neuromuscular or long-lasting low-energy condition. Healthy comparison volunteers can also join.
- Earlier treatment
- People must be willing to avoid changing their treatment on purpose just for this study. The study gives no treatment.
Main reasons for not taking part
- A condition that makes grip or sit-to-stand testing unsafe
- Unstable health, a recent hospital stay, or symptoms needing urgent care
- Cannot consent or follow the study without an approved legal representative
- Planned part in another trial that tests a treatment during the study
- No approved home function test that can be used safely
The registry criteria, word for word
Show all 10 criteriaShow less
Who can take part
- 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
- Willingness to complete baseline and repeated assessments for 12 weeks and to avoid intentional treatment changes solely for this study
Who cannot take part
- 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
- No usable approved functional protocol after safety screening; Participants meeting the dedicated POLG cohort definition are assigned to that cohort rather than the broad mitochondrial cohort. Final eligibility and cohort assignment are determined by qualified study personnel. Software may collect and flag screening information but does not make the final enrollment decision
Where in United States
- Precision MitoFort Myers, United StatesContact: Andrew Friedl, MS, MBANo longer taking part
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 7 groups in the trial
- Healthy comparison participants
Adults without a diagnosed or suspected mitochondrial disorder, active cancer, Lyme disease, or a persistent energy-limiting condition. Participants complete the same schedule and safety screening as the patient cohorts.
Treatment: Mito Map Energy Score and Home Functional Assessments
- Mitochondrial disease
Adults with confirmed or suspected primary mitochondrial disease or clinically documented mitochondrial dysfunction who do not meet the dedicated POLG cohort definition. Participants meeting the POLG cohort definition are assigned to the dedicated POLG cohort rather than this broad mitochondrial cohort. Diagnostic certainty, genetic findings, syndrome, phenotype, and severity are recorded without representing suspected disease as genetically confirmed disease.
Treatment: Mito Map Energy Score and Home Functional Assessments
- Post-infectious and autonomic illness
Adults with ME/CFS, Long COVID, POTS or dysautonomia, or a related post-infectious or autonomic energy-limiting illness. Lyme disease participants whose current index condition is Lyme-related are assigned to the separate Lyme cohort.
Treatment: Mito Map Energy Score and Home Functional Assessments
- Cancer and cancer survivorship
Adults with active cancer, a history of cancer, or treatment-related fatigue for whom remote functional testing is appropriate. Disease status, treatment status, time since treatment, and major fatigue confounders are recorded.
Treatment: Mito Map Energy Score and Home Functional Assessments
- Other persistent energy-limiting conditions
Adults with neuromuscular disease, fibromyalgia, complex chronic illness, or another qualifying persistent energy-limiting condition that is not assigned to another predefined cohort.
Treatment: Mito Map Energy Score and Home Functional Assessments
- Lyme disease and post-treatment Lyme disease syndrome
Adults with clinician-diagnosed Lyme disease, including persistent symptoms following recommended treatment when documented. Diagnostic basis, treatment history, time since treatment, symptom duration, coinfections, and alternative explanations are recorded. Enrollment does not imply persistent infection.
Treatment: Mito Map Energy Score and Home Functional Assessments
- POLG-related disease
Adults with confirmed or suspected POLG-related disease based on documented genetic findings or a specialist clinical diagnosis. Participants meeting this dedicated cohort definition are assigned here rather than to the broad mitochondrial cohort. Genetic findings, variant classification, zygosity, phenotype, diagnostic certainty, and disease severity are recorded without representing suspected disease or uncertain variants as genetically confirmed disease. This 50-person planning cohort is intended for descriptive and exploratory analyses and is not separately powered for confirmatory POLG-specific, variant-level, prognostic, or treatment-response claims.
Treatment: Mito Map Energy Score and Home Functional Assessments
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- An AI-Enabled Longitudinal Study of Energy, Symptoms, Function, and Physiology Across Mitochondrial and Energy-Limiting Conditions
- Plain-language title
- Tracking Energy Levels in People With Mitochondrial Disease and Other Fatiguing ConditionsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 2 October 2026