Validation of Minimally Invasive Oxygen Nanosensor to Measure Mitochondrial Function in Human Muscle

What this Trial Is About

Researchers are studying mitochondrial myopathy (MM), a condition causing muscle weakness, fatigue, and exercise intolerance, to improve diagnostic and treatment methods. The study evaluates a new device called a nanosensor, which measures oxygen levels in muscle tissue as a marker of mitochondrial function. This Phase 1 trial aims to determine how well the nanosensor can distinguish MM patients from healthy individuals, addressing the need for reliable biomarkers in this disease. Participants include adults aged 18 to 65, both with genetically confirmed MM and healthy volunteers matched by age, sex, and body mass index. The study involves placing a small nanosensor into the dominant forearm muscle under local anesthesia. Muscle oxygen levels are then measured during handgrip exercises. The trial monitors oxygen levels before, during, and after exercise, along with pain assessments related to the device placement. During the study, participants will perform handgrip exercises and may undergo cardiopulmonary exercise testing (CPET). Researchers will track muscle oxygen levels up to four hours after exercise and up to 40 days post-screening. Secondary assessments include self-reported pain, fatigue, and patient satisfaction approximately 40 days after procedures. This helps evaluate the nanosensor’s performance and participant experience, with careful monitoring throughout the study.

Validation of Nanosensor Oxygen Measurement