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Defining 31Phosphorous Magnetic Resonance Spectroscopy Characteristics in Patients With Mitochondrial Myopathy

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ClinicalTrials.gov Identifier: NCT01301235
Recruitment Status : Completed
First Posted : February 23, 2011
Last Update Posted : April 30, 2012
Information provided by (Responsible Party):

Study Description
Brief Summary:
This is a developmental protocol to determine the MRI based 31P-MRS changes seen in subjects with mitochondrial myopathy using our dynamic exercise protocol and to identify the ideal variable(s) to represent mitochondrial function.

Condition or disease
Mitochondrial Disease

Study Design

Study Type : Observational
Actual Enrollment : 8 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Defining 31Phosphorous Magnetic Resonance Spectroscopy Characteristics of the Vastus Lateralis After Sub-maximal Exercise in Patients With Mitochondrial Myopathy
Study Start Date : February 2011
Primary Completion Date : November 2011
Study Completion Date : April 2012

Groups and Cohorts

Subjects with mitochondrial disease

Outcome Measures

Primary Outcome Measures :
  1. PCr recovery after submaximal exercise by 31P-MRS [ Time Frame: 1 year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults with mitochondrial disease

Inclusion Criteria:

  1. Men and women ≥ age 18 years old with primary mitochondrial myopathy
  2. Known alteration in electron transport chain activity (<25 % activity of ETC) or known mutations in mitochondrial gene.

Exclusion Criteria:

Failure based on standard clinical MRI Screening form - the form is intended to establish the safety of subjects participating in the MRI scan without divulging any confidentiality information -

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01301235

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
More Information

Responsible Party: Amy Fleischman, MD, Clinical Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01301235     History of Changes
Other Study ID Numbers: 2010P002441
First Posted: February 23, 2011    Key Record Dates
Last Update Posted: April 30, 2012
Last Verified: April 2012

Keywords provided by Amy Fleischman, MD, Massachusetts General Hospital:

Additional relevant MeSH terms:
Mitochondrial Diseases
Mitochondrial Myopathies
Metabolic Diseases
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases