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Oxygen Nanosensor for Mitochondrial Myopathy

Phase 1

Recruiting

Led By Zarazuela Zolkipli-Cunningham

Research Sponsored by Children's Hospital of Philadelphia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Males and females, between the ages of 18 and 65 years, inclusive

Genetically-confirmed MM as defined by a diagnosis of primary mitochondrial disease (PMD) with predominant symptoms of myopathy as expressed by exercise intolerance and muscle weakness and fatigue.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 60 minutes for data collection at each 2 study visits, up to 6 months.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new way to measure mitochondrial function in human muscle tissue, which may help improve diagnostic and therapeutic approaches for patients with mitochondrial disease.

Who is the study for?

This trial is for adults aged 18-65 with genetically confirmed mitochondrial myopathy, characterized by exercise intolerance and muscle weakness. Healthy volunteers must be able to walk, do bike exercises, and give informed consent. People are excluded if they don't meet these criteria or can't follow the study protocol.

What is being tested?

The trial is testing an electrochemical oxygen nanosensor designed to measure mitochondrial function in human muscle tissue. It aims to distinguish between MM patients and healthy individuals, potentially aiding future diagnosis and treatment of mitochondrial diseases.

What are the potential side effects?

Since this trial involves a diagnostic tool rather than a medication or invasive therapy, direct side effects from the nanosensor itself may be minimal or non-existent; however, any potential discomfort from its application will be monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old.

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I have a genetic condition causing muscle weakness, especially after exercise.

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I can walk on my own without help.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 60 minutes for data collection at each 2 study visits, up to 6 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~60 minutes for data collection at each 2 study visits, up to 6 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 minutes for data collection at each 2 study visits, up to 6 months. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Nanosensor-muscle oxygen (Torr) levels

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Healthy ControlsExperimental Treatment1 Intervention

Adult healthy volunteers will be individually matched with corresponding MM cases based on age, biological sex, and body mass index.

Group II: Affected MM CasesExperimental Treatment1 Intervention

Key eligibility criteria for MM cases includes physically-capable adults (male and females, ages 18 to 65 years, inclusive) with genetically-confirmed MM with predominant symptoms of myopathy as expressed by exercise intolerance and muscle weakness and fatigue.

0 / 3Eligibility criteria met