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Completed

NCT Number: NCT06180421

Mitochondrial Video Assessment Source Material Study

Source material collection of videos to develop the Mitochondrial Video Assessment (MVA) for patients with mitochondrial myopathies.

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Key information

Conditions

PolG, Primary Mitochondrial Myopathy Brain Diseases Brain Diseases, Metabolic Brain Diseases, Metabolic, Inborn Cardiovascular Diseases Central Nervous System Diseases Cerebral Small Vessel Diseases Cerebrovascular Disorders Chronic Disease Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cranial Nerve Diseases Disease Attributes Eye Diseases Genetic Diseases, Inborn MELAS Syndrome Metabolic Diseases Metabolism, Inborn Errors Mitochondrial Diseases Mitochondrial Encephalomyopathies Mitochondrial Myopathies Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Nutritional and Metabolic Diseases Ocular Motility Disorders Ophthalmoplegia Ophthalmoplegia, Chronic Progressive External Paralysis Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Casimir

Kingston, Massachusetts, 02360, United States

About this study

This observational research is being conducted to facilitate the development of 2 related, disease-specific outcome measures assessing ease of movement in PMM and PolG clinical trials. The Mitochondrial Video Assessment (MVA) utilizes remote video capture to assess subtle shifts in compensatory movement patterns and measure change in function over time, and the Current State Questionnaire asks participants about external factors in their daily lives which may influence fluctuations in their symptoms. As part of the questionnaire, participants are asked to rate their own perception of their functional ability using a Patient Global Impression of Severity (PGI-S) scale.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 16 years old and above
  • Confirmed diagnosis of PMM or PolG
  • Ability to understand and speak English
  • Ability and willing to consent
  • Able and willing to participate and perform tasks while being recorded
  • Designating a recording partner to assist with video captures is strongly advised, but not required

Exclusion criteria

  • N/A

Treatment and study plan

Primary outcomes

  1. Source Material Videos

    Time frame: 2 weeks

    Initiate feasibility testing and collect source material videos from patients with Primary Mitochondrial Myopathy (PMM, n=35) or a PolGamma (PolG) mutation (n=15) to facilitate development of the Mitochondrial Video Assessment (MVA).

Secondary outcomes

  1. PGI-S

    Time frame: 2 weeks

    Identify external factors which may influence participant performance on functional assessments and collect Patient Global Impression of Severity (PGI-S) at the time of each capture to facilitate the development of a patient-reported Current State Questionnaire to be deployed in conjunction with the MVA.

Sponsors and collaborators

Lead sponsor

The Emmes Company, LLC

Industry

Collaborators

  • United Mitochondrial Disease Foundation

Registry information

Official study title

Development of the Mitochondrial Video Assessment (MVA) as an Outcome Measure for the Evaluation of Patients With Mitochondrial Myopathies

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 22, 2023
Registry last updated
Nov 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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