MRI in Patients With Kennedy Disease
This trial is active, not recruiting.
|Conditions||bulbo-spinal atrophy, x-linked, kennedy disease|
|Treatment||no intervention, observational|
|Start date||September 2015|
|End date||December 2016|
|Trial size||60 participants|
|Trial identifier||NCT02501395, H-15006316|
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.
|Observational model||case control|
Men over 18 years old with confirmed Kennedy disease.
Gender and age matched healthy, voluntary controls.
Muscle fat fraction
time frame: One MRI scan per subject (exam lasts approximately 60 min.)
time frame: One muscle strength test per subject (exam lasts approximately 60 min.)
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.)
Male participants at least 18 years old.
Patients with Kennedy disease: Inclusion Criteria: - Confirmed Kennedy disease Exclusion Criteria: - All contraindications for undergoing an MRI scan Healthy controls Inclusion Criteria: - Fit age and gender criteria Exclusion Criteria: - All contraindications for undergoing an MRI scan
|Official title||MRI in Patients With Kennedy Disease|
|Principal investigator||Julia R Dahlqvist, MD|
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