MRI in Patients With Kennedy Disease

Rigshospitalet

Status: Completed

Conditions: Bulbo-Spinal Atrophy, X-Linked; Kennedy Disease

Treatments: Other: No intervention, observational

Study type: Observational

Funder types: Other

Identifiers

NCT02501395

H-15006316

Details and patient eligibility

About

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.

Enrollment: 53 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

53 participants in 2 patient groups

Patients with Kennedy disease

Description:

Men over 18 years old with confirmed Kennedy disease.

Treatment:

Other: No intervention, observational

Healthy, voluntary controls

Description:

Gender and age matched healthy, voluntary controls.

Treatment:

Other: No intervention, observational