Clinical Trial: Validation of Oxygen Nanosensor in Mitochondrial Myopathy
Study Status: RECRUITING
Recruit Status: RECRUITING
Study Type: INTERVENTIONAL
Official Title: The Development of Minimally Invasive Nanosensor Technology to Quantify Mitochondrial Function in Human Muscle
Brief Summary:
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.
Detailed Summary:
This is an investigational device clinical trial.
MM cases and healthy volunteers will undergo nanosensor muscle oxygen measurement in exercised (dominant) forearm muscle during handgrip exercise.
The same measurements will be repeated between 7 and 30 days later in the same forearm and at the same time of day for each participant to assess reproducibility.
After placement of the nanosensor in the forearm under local anesthesia, the primary outcome measure is nanosensor-muscle oxygen levels.
The secondary outcome measure is an assessment of pain.
Sponsor: Children's Hospital of Philadelphia
Current Primary Outcome: Nanosensor measured muscle O2 levels at baseline, during handgrip exercise and after exercise
Original Primary Outcome: Nanosensor measured muscle O2 levels at baseline, during handgrip exercise and after exercise
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Children's Hospital of Philadelphia
Dates:
Date Received: September 06, 2019
Date Started: January 17, 2023
Date Completion: January 17, 2023
Last Updated: February 20, 2023
Last Verified: February 01, 2023
