Clinical Trial: MRI in Patients With Kennedy Disease

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

Official Title: MRI in Patients With Kennedy Disease

Brief Summary:

Kennedy disease is an inherited neuromuscular disorder that is characterized by progressive muscle wasting and weakness. It typically starts with muscle spasms and tremors in the arms, followed by muscle weakness and atrophy of muscles in the arms and legs. The facial and bulbar muscles are also involved. However, the muscle involvement pattern has not been investigated systemically in Kennedy disease.

The primary aim of the study is to investigate the muscle involvement in patients with Kennedy disease using MRI. Secondary aims are to examine disease severity and to test MRI as a potential outcome measure for future clinical trials in Kennedy disease.

Approximately 40 patients with Kennedy disease and 20 gender and age matched healthy voluntary controls will be recruited. The study consists of one visit per subject lasting 4-5 hours.


Detailed Summary:
Sponsor: Rigshospitalet, Denmark

Current Primary Outcome: Muscle fat fraction [ Time Frame: One MRI scan per subject (exam lasts approximately 60 min.) ]

The Dixon MRI will be used to quantify the fat fraction in skeletal muscle.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Muscle strength [ Time Frame: One muscle strength test per subject (exam lasts approximately 60 min.) ]
    Isokinetic muscle dynamometry will be used to measure muscle strength.
  • Minimal dataset for data collection in Kennedy disease [ Time Frame: Data will be collected once for patients with Kennedy disease (exam lasts approximately 90 min.) ]
    The 'minimal dataset for data collection in Kennedy disease' will be used to investigate the clinical spectrum of Kennedy disease.


Original Secondary Outcome: Same as current

Information By: Rigshospitalet, Denmark

Dates:
Date Received: July 14, 2015
Date Started: September 2015
Date Completion: June 2017
Last Updated: April 10, 2017
Last Verified: April 2017