The Precision Mito- Mito Map COMPASS Study

Conditions

• Cancer-Related Fatigue
• Fatigue
• Fibromyalgia
• Lyme Disease
• Mitochondrial Diseases
• Myalgic Encephalomyelitis Chronic Fatigue Syndrome
• Neuromuscular Diseases
• POLG-Related Disorders
• Post-COVID-19 Condition
• Post-Treatment Lyme Disease Syndrome
• Postural Orthostatic Tachycardia Syndrome

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Mito Map Energy Score and Home Functional Assessments — OTHER
  Observational 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.

Study Details

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.

Key Dates

First listed

Oct 2, 2026

Start date

Nov 1, 2026

Status verified

Sep 2026

Primary completion

Nov 1, 2029

Completion

Nov 1, 2029

Study Design

Enrollment

400 participants (estimated)

Arms

• Arm: 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.
• Arm: 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.
• Arm: 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.
• Arm: 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.
• Arm: 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.
• Arm: 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.
• Arm: 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.

Primary Outcome Measure

Within-participant association between canonical Energy Score and objective home function composite [ Time Frame: Baseline through week 12 ]

Central Contacts

• Andrew Friedl, MS, MBA
  224-442-4247
  [email protected]
• Deborah Manst, MD
  224-442-4247
  [email protected]

Locations (1)

Find similar trials in Fort Myers, FL

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