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Trial record 2 of 90 for:    "Brain Diseases" AND "Multiple System Atrophy"

Cognitive and Behavioral Dysexecutive Syndrome in Multiple System Atrophy (CogAMS)

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ClinicalTrials.gov Identifier: NCT02185677
Recruitment Status : Completed
First Posted : July 9, 2014
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

Brief 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 .

Condition or disease Intervention/treatment
Multiple System Atrophy Other: Clinical evaluation Other: neuropsychological battery test Other: MRI Other: Actigraphy

Detailed 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.


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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
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.
Actual Study Start Date : May 14, 2014
Actual Primary Completion Date : June 25, 2015
Actual Study Completion Date : June 26, 2015

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
MSA-P Other: Clinical evaluation
Other: neuropsychological battery test
Other: MRI
Other: Actigraphy
Actigraphy recording will be performed during 7 days after inclusion.

MSA-C Other: Clinical evaluation
Other: neuropsychological battery test
Other: MRI
Other: Actigraphy
Actigraphy recording will be performed during 7 days after inclusion.




Primary Outcome Measures :
  1. Behavioral Dysexecutive Syndrome Inventory scores [ Time Frame: At inclusion (day 0) ]

Secondary Outcome Measures :
  1. To compare the subscores of the BDSI between MSA-P patients and MSA-C patients. [ Time Frame: At inclusion (Day 0) ]
  2. To compare the cognitive tests exploring the cognitive dysexecutive syndrome between MSA-P patients and MSA-C patients. [ Time Frame: At inclusion (Day 0) ]
    • Trail making Test
    • Stroop Test
    • Modfied Card Sorting Test
    • Brixton Test
    • Verbal fluency Test
    • Six Elements Test

  3. To research correlations between scores UMSARS and cognitive and behavioral scores for MSA-P patients and MSA-C patients. [ Time Frame: At inclusion (Day 0) ]
    Assessment using the Behavioral Dysexecutive Syndrome Inventory

  4. To compare atrophied brain areas, the anatomic and functional abnormalities of neural networks between MSA-P patients and MSA-C patients. [ Time Frame: At inclusion (Day 0) ]
  5. To research correlations between imaging abnormalities and cognitive test performance in MSA patients. [ Time Frame: At inclusion (day 0) ]
  6. Actigraphy [ Time Frame: During 7 days after inclusion ]

    Sleep analysis :

    Sleep / wake cycles and sleep fragmentation




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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients suffering from MSA-P or MSA-C
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02185677


Locations
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France
CHU de Bordeaux
Bordeaux, France, 33000
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
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Principal Investigator: Alexandra FOUBERT-SAMIER, MD University Hospital, Bordeaux
Study Chair: Rodolphe THIEBAUT, MD, PhD University Hospital, Bordeaux

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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT02185677     History of Changes
Other Study ID Numbers: CHUBX 2013/07
First Posted: July 9, 2014    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019

Keywords provided by University Hospital, Bordeaux:
dysexecutive syndrome
multiple system atrophy
imaging study

Additional relevant MeSH terms:
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Multiple System Atrophy
Shy-Drager Syndrome
Brain Diseases
Atrophy
Pathological Conditions, Anatomical
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases
Basal Ganglia Diseases
Central Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Hypotension
Vascular Diseases
Cardiovascular Diseases