MRI in Patients With Kennedy Disease

June 1, 2018 updated by: Julia Dahlqvist, MD, Rigshospitalet, Denmark

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

53

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Copenhagen Neuromuscular Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
One MRI scan per subject (exam lasts approximately 60 min.)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.)
The 'minimal dataset for data collection in Kennedy disease' will be used to investigate the clinical spectrum of Kennedy disease.
Data will be collected once for patients with Kennedy disease (exam lasts approximately 90 min.)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Investigators

  • Principal Investigator: Julia R Dahlqvist, MD, Copenhagen Neuromuscular Center, Department of Neurology, Rigshospitalet, Copenhagen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

May 1, 2018

Study Registration Dates

First Submitted

July 14, 2015

First Submitted That Met QC Criteria

July 15, 2015

First Posted (Estimate)

July 17, 2015

Study Record Updates

Last Update Posted (Actual)

June 4, 2018

Last Update Submitted That Met QC Criteria

June 1, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-15006316

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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