NCT02729597|Completed
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Sponsor study identifier
observational
49
0 countries
N/A
Study Start
May 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2014
Actual (reported)Study Completion
August 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2007
Date type not reportedThis date has not been verified as actual or estimated.
December 2014
Actual (reported)August 2015
Actual (reported)March 23, 2016
Actual (reported)April 6, 2016
Actual (reported)Change in diffusivity indices as assessed by brain MRI with diffusion tensor imaging (DTI) sequences
First analysis at baseline and after 5 years at follow-up
Gray matter changes assessed by magnetic resonance imaging (MRI)-voxel-based morphometry (VBM)
First analysis at baseline and after 5 years at follow-up
Quantification of white matter lesions using age-related white matter changes (ARWMC) rating scale
First analysis at baseline and after 5 years at follow-up
MIRS (Muscular impairment rating scale)
First analysis at baseline and after 5 years at follow-up
Motor performance (Purdue Pegboard, bimanual)
First analysis at baseline and after 5 years at follow-up
Beck Depression Inventory (BDI)
First analysis at baseline and after 5 years at follow-up
Boston Naming Test
First analysis at baseline and after 5 years at follow-up
Verbal memory recognition task, a subtest of a computerised neuropsychological screening test battery, named NeuroCogFX (Fliessbach et al., 2006).
First analysis at baseline and after 5 years at follow-up
Patients with myotonic dystrophy type 1 (diagnosis confirmed by genetic testing) who meet all inclusion and exclusion criteria for patients. To be assessed at baseline and follow-up: medical history, neurological clinical examination, neuropsychological testing, brain MRI
Patients with myotonic dystrophy type 2 (diagnosis confirmed by genetic testing) who meet all inclusion and exclusion criteria for patients. To be assessed at baseline and follow-up: medical history, neurological clinical examination, neuropsychological testing, brain MRI
The complete medical history (including cardiovascular risk factors and medication) will be assessed at baseline and follow-up.
Patients with genetically proven myotonic dystrophy type 1 and myotonic dystrophy type 2 and healthy controls
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
49 participants (actual enrollment reported by the registry).
First Submitted
March 23, 2016
First Posted
April 6, 2016
Study Start
May 2007
Date type not reportedThis date has not been verified as actual or estimated.
Effects of SomatoKine (Iplex)Recombinant Human Insulin-like Growth Factor-1/Recombinant Human Insulin-like Growth Factor-binding Protein-3 (rhIGF-I/rhIGFBP-3) in Myotonic Dystrophy Type 1 (DM1)
Healthy control subjects who meet all inclusion and exclusion criteria for healthy controls. To be assessed at baseline and follow-up: medical history, neurological clinical examination, neuropsychological testing, brain MRI
Neurological examination will be performed at baseline and follow-up.
Neuropsychological testing using a 13 item test battery will be performed at baseline and follow-up.
Brain MRI ( 3.0 T) will be performed using the same hard- and software at baseline and follow-up.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
December 2014
Actual (reported)Study Completion
August 2015
Actual (reported)Last Updated
April 6, 2016
Record last verified: 2016-04
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Source: ClinicalTrials.gov.
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