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MRI in Patients With Kennedy Disease

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ClinicalTrials.gov Identifier: NCT02501395
Recruitment Status : Completed
First Posted : July 17, 2015
Last Update Posted : June 4, 2018
Sponsor:
Information provided by (Responsible Party):
Julia Dahlqvist, MD, Rigshospitalet, Denmark

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.


Condition or disease Intervention/treatment
Bulbo-Spinal Atrophy, X-Linked Kennedy Disease Other: No intervention, observational

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Study Type : Observational
Actual Enrollment : 53 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: MRI in Patients With Kennedy Disease
Study Start Date : September 2015
Actual Primary Completion Date : February 2017
Actual Study Completion Date : May 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients with Kennedy disease
Men over 18 years old with confirmed Kennedy disease.
Other: No intervention, observational
Healthy, voluntary controls
Gender and age matched healthy, voluntary controls.
Other: No intervention, observational



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Persons in Denmark diagnosed with Kennedy disease is invited to the study.

Gender and age matched controls will be recruited to a control group.

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02501395


Locations
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Denmark
Copenhagen Neuromuscular Center
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
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Principal Investigator: Julia R Dahlqvist, MD Copenhagen Neuromuscular Center, Department of Neurology, Rigshospitalet, Copenhagen University

Additional Information:
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Responsible Party: Julia Dahlqvist, MD, MD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02501395     History of Changes
Other Study ID Numbers: H-15006316
First Posted: July 17, 2015    Key Record Dates
Last Update Posted: June 4, 2018
Last Verified: June 2018

Additional relevant MeSH terms:
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Atrophy
Bulbo-Spinal Atrophy, X-Linked
Pathological Conditions, Anatomical
Muscular Atrophy, Spinal
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Motor Neuron Disease
Neuromuscular Diseases
Genetic Diseases, X-Linked
Genetic Diseases, Inborn