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Clinical Trials/NCT02161848
NCT02161848
Completed
Not Applicable

Magnetic Resonance Imaging Study of Patients With Chronic Progressive External Ophthalmoplegia

Rigshospitalet, Denmark1 site in 1 country133 target enrollmentJune 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Progressive External Ophthalmoplegia
Sponsor
Rigshospitalet, Denmark
Enrollment
133
Locations
1
Primary Endpoint
Fat fraction in the muscles of the lower bag, thighs and calves
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

The purpose of this study is to investigate the fraction of fat on a MRI scan of lower bag muscles, thighs and calves in patients with the mitochondrial disease chronic progressive external ophthalmoplegia (CPEO).

Additionally an investigation of the volume of the eye muscles will be done and compared to the patient's clinical presentation of ptosis and ophthalmoplegia.

Detailed Description

The lack of energy and fatigue seen in patients with mitochondrial diseases have been assumed to be caused by an energy defect because of a genetic defect in the mitochondrial DNA. The investigators have analyzed a few MRI scans of muscles from patients with CPEO and have seen an extended amount of fat in their muscles, which seems to progress with age. The patient's symptoms might be caused by the extended amount of fat and thereby a less amount of active muscle instead of the "energy defect". This will be investigated in a group of patients with CPEO and the results will be compared with results from a group of healthy controls.

Registry
clinicaltrials.gov
Start Date
June 2014
End Date
October 2015
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Gitte Hedermann Pedersen

Bsc.

Rigshospitalet, Denmark

Eligibility Criteria

Inclusion Criteria

  • Danish patients with verified single large-scale mtDNA deletions and chronic progressive external ophthalmoplegia.

Exclusion Criteria

  • Patients who have metal implants in the body, for instance surgical clips, cochlear implant, pacemaker etc.
  • Patients who are pregnant or breast-feeding.
  • Patients who are claustrophobic

Outcomes

Primary Outcomes

Fat fraction in the muscles of the lower bag, thighs and calves

Time Frame: 1 day

The investigators will make a 3-point Dixon scan of the muscles of the lower bag, thighs and calves and measure the fraction of fat in these muscles once per patient or control.

Secondary Outcomes

  • Isokinetic muscle dynamometry of ankle flexion(1 day)
  • Isokinetic muscle dynamometry of knee flexion.(1 day)
  • Isokinetic muscle dynamometry of ankle extension(1 day)
  • Isokinetic muscle dynamometry of knee extension(1 day)

Study Sites (1)

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