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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amy Fleischman, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01301235
First received: February 18, 2011
Last updated: April 27, 2012
Last verified: April 2012
  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 Massachusetts General Hospital:

Primary Outcome Measures:
  • PCr recovery after submaximal exercise by 31P-MRS [ Time Frame: 1 year ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01301235

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

No publications provided

Responsible Party: Amy Fleischman, MD, Clinical Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01301235     History of Changes
Other Study ID Numbers: 2010P002441
Study First Received: February 18, 2011
Last Updated: April 27, 2012
Health Authority: United States: Partners Human Research Committee

Keywords provided by Massachusetts General Hospital:
Mitochondria

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

ClinicalTrials.gov processed this record on April 17, 2014