Actively Recruiting
Validation of Oxygen Nanosensor in Mitochondrial Myopathy
Led by Children's Hospital of Philadelphia · Updated on 2026-02-18
24
Participants Needed
1
Research Sites
236 weeks
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
Past mitochondrial disease treatment studies have been unsuccessful in determining treatment efficacy, and a major factor has been the lack of validated biomarkers in mitochondrial myopathy (MM). There is currently a growing number of potential new treatments to be tested through MM clinical intervention trials, which has created a pressing need for quantitative biomarkers that reliably reflect MM disease severity, progression, and therapeutic response. The purpose of the study is to measure the efficacy of an electrochemical oxygen nanosensor to measure in vivo mitochondrial function in human muscle tissue, and its ability to discriminate MM patients from healthy volunteers. The data and results from this nanosensor study may contribute to current and future research, including improved diagnostic and therapeutic approaches for patients with mitochondrial disease.
CONDITIONS
Official Title
Validation of Oxygen Nanosensor in Mitochondrial Myopathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females between 18 and 65 years of age
- Able to provide informed consent and understand the study protocol
- Able to walk independently
- Able to perform bicycle exercise testing
- For MM patients: genetically confirmed mitochondrial myopathy with symptoms of exercise intolerance, muscle weakness, and fatigue
- MM patients must be enrolled or enroll in one of two specified CHOP IRB studies
You will not qualify if you...
- Unable to provide informed consent or complete study procedures
- Unable to walk independently
- Pregnant
- Hospitalized for acute illness within the past month
- Severe heart disease with ejection fraction below 35% or severe lung disease needing oxygen or ventilatory support
- Having a tracheostomy
- Known bleeding disorders or family history of bleeding disorders
- Taking aspirin or other anti-platelet drugs that cannot be temporarily stopped
- Immune deficiencies, immunosuppressive drug use, frequent severe infections, or poor wound healing
- Chronic steroid use or untreated endocrinopathies causing muscle problems
- Prone to hypertrophic scars or keloids
- Other inherited muscle diseases like Duchenne muscular dystrophy
- Allergy to lidocaine
- Cognitive impairments preventing study participation
- Unable to follow study requirements or deemed unsuitable by the investigator
- Vulnerable populations such as prisoners
- Inability to speak or read English
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
S
Sara Nguyen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here