MRI Study - Chronic Progressive External Ophthalmoplegia

Chronic Progressive External Ophthalmoplegia Clinical Trial

— CPEO  

Official title:

Magnetic Resonance Imaging Study of Patients With Chronic Progressive External Ophthalmoplegia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02161848
• Other study ID #: H-3-2012-163 (CPEO)
• Status: Completed
• Phase: N/A
• First received: June 6, 2014
• Last updated: April 13, 2016
• Start date: June 2014
• Est. completion date: October 2015

Study information

• Verified date: April 2016
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics CommitteeDenmark: Danish Dataprotection Agency
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Chronic Progressive External Ophthalmoplegia
• Ophthalmoplegia

Intervention

Other:
• Magnetic Resonance Imaging
MRI of eye muscles, lower bag muscles, thigh muscles and calf muscles.

Locations

Country	Name	City	State
Denmark	Neuromuscular Research Unit	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	MRI T1 scan of eye muscles	Investigation of the volume of the eye muscles on a MRI scan and compare these with the patients clinical presentation of ptosis and ophthalmoplegia. The MRI scan is done once per patient or control and at the same day as the other MRI scans.	1 day	No
Primary	Fat fraction in the muscles of the lower bag, thighs and calves	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.	1 day	No
Secondary	Isokinetic muscle dynamometry of ankle flexion	Isokinetic muscle dynamometry of ankle flexion. This is made on a Biodex 3 and done once per patient or control the same day as the MRI-scan is done. These results are correlated with the amount of non-fat-infiltrated muscle on the MRI scans.	1 day	No
Secondary	Isokinetic muscle dynamometry of ankle extension	Isokinetic muscle dynamometry of ankle extension. This is made on a Biodex 3 and done once per patient or control the same day as the MRI-scan is done. These results are correlated with the amount of non-fat-infiltrated muscle on the MRI scans.	1 day	No
Secondary	Isokinetic muscle dynamometry of knee flexion.	Isokinetic muscle dynamometry of knee flexion. This is made on a Biodex 3 and done once per patient or control the same day as the MRI-scan is done. These results are correlated with the amount of non-fat-infiltrated muscle on the MRI scans.	1 day	No
Secondary	Isokinetic muscle dynamometry of knee extension	Isokinetic muscle dynamometry of knee extension. This is made on a Biodex 3 and done once per patient or control the same day as the MRI-scan is done. These results are correlated with the amount of non-fat-infiltrated muscle on the MRI scans.	1 day	No