Defining 31Phosphorous Magnetic Resonance Spectroscopy Characteristics in Patients With Mitochondrial Myopathy
This study has been completed.
Information provided by (Responsible Party):
Amy Fleischman, MD, Massachusetts General Hospital
First received: February 18, 2011
Last updated: April 27, 2012
Last verified: April 2012
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.
||Observational Model: Case-Only
Time Perspective: Cross-Sectional
||Defining 31Phosphorous Magnetic Resonance Spectroscopy Characteristics of the Vastus Lateralis After Sub-maximal Exercise in Patients With Mitochondrial Myopathy
Primary Outcome Measures:
- PCr recovery after submaximal exercise by 31P-MRS [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||November 2011 (Final data collection date for primary outcome measure)
Subjects with mitochondrial disease
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Adults with mitochondrial disease
- Men and women ≥ age 18 years old with primary mitochondrial myopathy
- Known alteration in electron transport chain activity (<25 % activity of ETC) or known mutations in mitochondrial gene.
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 -
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
|Massachusetts General Hospital
|Boston, Massachusetts, United States, 02114 |
Massachusetts General Hospital
No publications provided
||Amy Fleischman, MD, Clinical Investigator, Massachusetts General Hospital
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 18, 2011
||April 27, 2012
||United States: Partners Human Research Committee
Keywords provided by Massachusetts General Hospital:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 02, 2015
Nervous System Diseases