MRI in Patients With Kennedy Disease

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.

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Key information

Conditions

Bulbo-Spinal Atrophy, X-Linked Central Nervous System Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Genetic Diseases, X-Linked Heredodegenerative Disorders, Nervous System Kennedy Disease Motor Neuron Disease Muscular Atrophy, Spinal Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Spinal Cord Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Copenhagen Neuromuscular Center

Copenhagen, 2100, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention, observational

Other

Primary outcomes

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.

Secondary outcomes

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.

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Important dates

Study start: 2015
Primary completion: 2017
Study completion: 2018
First posted: Jul 17, 2015
Registry last updated: Jun 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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