Actively Recruiting
The Development of Minimally Invasive Nanosensor Technology to Quantify Mitochondrial Function in Human Muscle
Led by Children's Hospital of Philadelphia · Updated on 2026-02-18
24
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
C
Children's Hospital of Philadelphia
Lead Sponsor
N
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying mitochondrial myopathy (MM), a condition where mitochondrial function in muscle tissue is impaired. This investigational device trial aims to evaluate an electrochemical oxygen nanosensor's ability to measure mitochondrial function in human muscle and to distinguish MM patients from healthy volunteers. The study is motivated by the need for reliable biomarkers to assess MM severity, progression, and response to treatment. The study involves placing a small nanosensor device into the dominant forearm muscle under local anesthesia. Participants will perform handgrip exercises while the device measures oxygen levels in the muscle. These measurements will be taken at two visits spaced 7 to 30 days apart to check for consistency. The study includes two groups: adults aged 18 to 65 with genetically confirmed MM and matched healthy volunteers. Participants will undergo muscle oxygen level measurements during exercise, with data collected for up to 60 minutes at each visit. Researchers will also assess pain and tolerability associated with the nanosensor placement. The total study duration spans up to 6 months, including the two measurement visits. The study will help determine the device's reproducibility and potential use in future mitochondrial disease research.
CONDITIONS
Brief Title
Validation of Oxygen Nanosensor in Mitochondrial Myopathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 65 years, male or female
- Able to understand and provide informed consent
- Able to walk independently
- Able to perform bicycle ergometry testing
- For mitochondrial myopathy cases: genetically confirmed primary mitochondrial disease with symptoms of exercise intolerance, muscle weakness, and fatigue
- Previously or will be enrolled in specified Children's Hospital of Philadelphia IRB studies
You will not qualify if you...
- Unable to provide informed consent or complete study procedures
- Non-ambulatory or unable to walk independently
- Pregnant
- Hospitalized for acute illness within the past month
- Severe cardiac disease with ejection fraction less than 35% or severe pulmonary disease needing oxygen or ventilatory support
- Presence of tracheostomy
- Known bleeding disorder or family history of bleeding disorder
- Daily use of aspirin or anti-platelet therapy that cannot be stopped temporarily
- Known or suspected immune deficiency or current use of immunosuppressants including corticosteroids
- History of frequent severe skin or soft tissue infections or delayed wound healing
- Chronic steroid treatment or untreated endocrinopathies causing muscle disease
- Prone to hypertrophic scars or keloids
- Other inherited myopathies such as Duchenne muscular dystrophy
- Allergy to lidocaine
- Cognitive impairment interfering with study participation
- Unable to comply with study protocol or deemed unsuitable by the investigator
- Member of vulnerable populations (e.g., prisoners)
- Unable to read or speak English sufficiently to complete study procedures
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo placement of the nanosensor in the forearm muscle under local anesthesia to measure muscle oxygen levels during handgrip exercise.
1 visit (in-person)
Duration - 60 minutes per session, repeated between 7 and 30 days later
Participants have muscle oxygen measurements collected during handgrip exercise using the nanosensor.
2 visits (in-person)
Trial Site Locations
Total: 1 location
1
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
Z
Zarazuela Zolkipli-Cunningham
S
Sara Nguyen
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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