Trial record 3 of 41 for:    Mitochondrial Myopathies

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
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, see Learn About Clinical Studies.

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:
Mitochondrial Diseases
Mitochondrial Myopathies
Metabolic Diseases
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 16, 2014