We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01301235
First Posted: February 23, 2011
Last Update Posted: April 30, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Amy Fleischman, MD, Massachusetts General Hospital
  Purpose
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
Mitochondrial Disease

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Amy Fleischman, MD, Massachusetts General Hospital:

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

Enrollment: 8
Study Start Date: February 2011
Study Completion Date: April 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Subjects with mitochondrial disease

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
Criteria

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


Locations
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 Submitted: February 18, 2011
First Posted: February 23, 2011
Last Update Posted: April 30, 2012
Last Verified: April 2012

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

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