Cognitive and Behavioral Dysexecutive Syndrome in Multiple System Atrophy

Multiple System Atrophy Clinical Trial

— CogAMS  

Official title:

Comparison of Cognitive and Behavioral Dysexecutive Syndrome Between Parkinsonian Form and Cerebellar Form of Multiple System Atrophy and Analysis of Correlates With an Imaging Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02185677
• Other study ID #: CHUBX 2013/07
• Status: Completed
• Start date: May 14, 2014
• Est. completion date: June 26, 2015

Study information

• Verified date: February 2019
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The main objective of the study is to compare the score to the Behavioral Dysexecutive Syndrome Inventory (BDSI) between Parkinsonian Multiple system Atrophy MSA-P patients and cerebellar Multiple System Atrophy (MSA-C) patients matched on disease duration, age (± 7 years) and sex .

Description:

Multiple system atrophy (MSA) is a rare neurodegenerative disorder which is characterized by a variable combination of parkinsonism, cerebellar dysfunction, autonomic failure, and additional signs. According to the consensus criteria for the diagnosis of MSA, the presence of dementia is considered an exclusion criteria. However, several studies have reported cognitive impairment in patients with MSA, dominated by a dysexecutive syndrome. Some studies have compared the cognitive profile of MSA-P patients and MSA-C but any have studied the behavioral dysexecutive syndrome in this population. In 2010, the GREFFEX has established criteria for dysexecutive syndrome and described two distinct parts: the dysexecutive syndrome and cognitive behavioral dysexecutive syndrome. Our clinical impression is that according to the type of MSA, the dysexecutive syndrome seems to be different : the MSA-P patients seem to have a cognitive dysexecutive syndrome and the MSA-C patients a behavioral dysexecutive syndrome.

We want to compare the BDSI score between MSA-P patients and MSA-C patients matched on disease duration, age and sex The specific involvement of the cerebellum in behavioral disorders could explain the behavioral differences experienced by clinicians caring for these patients but never demonstrated. The presence of these disorders could have an impact on the relationship between the patient and the caregiver. In addition, few studies have correlated with cognitive imagery data. Therefore, the exact areas involved in cognitive and behavioral MSApatients remain poorly understood.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 26, 2015
• Est. primary completion date: June 25, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

Inclusion criteria:

• Patients suffering from "probable" MSA according to clinical consensus criteria (Gilman et al, 2008),

• Age >30

• Written informed consent

• Patient covered by the national health system

• The presence of an informant

• Blood negative dosage of the hormone béta-hCG for the women old enough to procreate

Exclusion criteria:

• UMSARS IV score > 4 points

• Pregnant woman (blood positive dosage of the hormone béta-hCG) or breast feeding

• Patient under tutelage

• Patient unable to give consent

• Against indication to perform an MRI

Related Conditions & MeSH terms

• Atrophy
• Multiple System Atrophy
• Shy-Drager Syndrome

Intervention

Other:
• Clinical evaluation

• neuropsychological battery test

• MRI

• Actigraphy
Actigraphy recording will be performed during 7 days after inclusion.

Locations

Country	Name	City	State
France	CHU de Bordeaux	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Behavioral Dysexecutive Syndrome Inventory scores		At inclusion (day 0)
Secondary	To compare the subscores of the BDSI between MSA-P patients and MSA-C patients.		At inclusion (Day 0)
Secondary	To compare the cognitive tests exploring the cognitive dysexecutive syndrome between MSA-P patients and MSA-C patients.	Trail making Test; Stroop Test; Modfied Card Sorting Test; Brixton Test; Verbal fluency Test; Six Elements Test	At inclusion (Day 0)
Secondary	To research correlations between scores UMSARS and cognitive and behavioral scores for MSA-P patients and MSA-C patients.	Assessment using the Behavioral Dysexecutive Syndrome Inventory	At inclusion (Day 0)
Secondary	To compare atrophied brain areas, the anatomic and functional abnormalities of neural networks between MSA-P patients and MSA-C patients.		At inclusion (Day 0)
Secondary	To research correlations between imaging abnormalities and cognitive test performance in MSA patients.		At inclusion (day 0)
Secondary	Actigraphy	Sleep analysis : Sleep / wake cycles and sleep fragmentation	During 7 days after inclusion