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Tracking the Brain in Myotonic Dystrophies: a 5-year Longitudinal Follow-up Study

NCT02729597 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 49

Last updated 2016-04-06

No results posted yet for this study

Summary

The natural history of brain affection in myotonic dystrophy types 1 and 2 is still unknown. The investigators designed a 5-year longitudinal neuropsychological and neuroimaging follow-up study to address this issue. Myotonic dystrophy type 1, myotonic dystrophy type 2 patients, and healthy controls were enrolled. All participants undergo clinical-neurological examinations, neuropsychological analyses according to a 13-item neuropsychological test battery, and 3T-brain MRI including voxel-based morphometry and diffusion tensor imaging at baseline and at follow-up using identical examination protocols.

Conditions

  • Myotonic Dystrophy 1
  • Myotonic Dystrophy 2

Interventions

OTHER

medical history

The complete medical history (including cardiovascular risk factors and medication) will be assessed at baseline and follow-up.

OTHER

neurological clinical examination

Neurological examination will be performed at baseline and follow-up.

OTHER

neuropsychological testing

Neuropsychological testing using a 13 item test battery will be performed at baseline and follow-up.

OTHER

brain MRI

Brain MRI ( 3.0 T) will be performed using the same hard- and software at baseline and follow-up.

Sponsors & Collaborators

  • Forschungszentrum Juelich

    collaborator OTHER

  • Life and Brain Center Bonn

    collaborator UNKNOWN

  • The Marigold Foundation

    collaborator UNKNOWN

  • University Hospital, Bonn

    lead OTHER

Principal Investigators

  • Cornelia Kornblum, Prof. Dr. · Department of Neurology, University Hospital of Bonn, Bonn, Germany

  • Bernd Weber, Prof. Dr. · Life and Brain Center, Department of NeuroCognition-Imaging, Bonn, Germany

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2014-12-31
Completion
2015-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02729597 on ClinicalTrials.gov