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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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Nanosensor-muscle oxygen (Torr) levels

Secondary outcome measures

Pain and tolerability

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

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National Institutes of Health (NIH)NIH

2,705 Previous Clinical Trials

7,507,262 Total Patients Enrolled

National Institute of Neurological Disorders and Stroke (NINDS)NIH

1,342 Previous Clinical Trials

650,328 Total Patients Enrolled

Children's Hospital of PhiladelphiaLead Sponsor

709 Previous Clinical Trials

8,587,693 Total Patients Enrolled

Media Library

Affected MM Cases Clinical Trial Eligibility Overview. Trial Name: NCT04086329 — Phase 1

Mitochondrial Disease Research Study Groups: Affected MM Cases, Healthy Controls

Mitochondrial Disease Clinical Trial 2023: Affected MM Cases Highlights & Side Effects. Trial Name: NCT04086329 — Phase 1

Affected MM Cases 2023 Treatment Timeline for Medical Study. Trial Name: NCT04086329 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many volunteers are taking part in this experiment?

"Affirmative. Clinicaltrials.gov provides evidence that this trial, which was posted on the first of January 2023, is presently recruiting participants. A total of 24 patients are needed for one clinical site to be involved in the study."

Answered by AI

What qualifications are necessary to participate in this clinical investigation?

"Meeting the criteria for entry requires that applicants must be between 18-65 years old and suffering from a mitochondrial illness. Up to 24 people can join this trial."

Answered by AI

Do the criteria for this clinical experiment involve individuals under 30 years of age?

"This trial requires that participants are between 18 and 65 years old, inclusive."

Answered by AI

Is this medical study currently enrolling participants?

"Clinicaltrials.gov reveals that this scientific experiment is still looking for participants, as the listing was last updated on November 30th 2022 - just weeks after its initial posting on January 1st 2023."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Validation of Oxygen Nanosensor in Mitochondrial Myopathy

Zarazuela Zolkipli Cunningham 2023. "Validation of Oxygen Nanosensor in Mitochondrial Myopathy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04086329.

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