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

February 22, 2019 updated by: University Hospital, Bordeaux

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.

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 .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33000
        • CHU de Bordeaux

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

28 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients suffering from MSA-P or MSA-C

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Behavioral Dysexecutive Syndrome Inventory scores
Time Frame: At inclusion (day 0)
At inclusion (day 0)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To compare the subscores of the BDSI between MSA-P patients and MSA-C patients.
Time Frame: At inclusion (Day 0)
At inclusion (Day 0)
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
At inclusion (Day 0)
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
At inclusion (Day 0)
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)
At inclusion (Day 0)
To research correlations between imaging abnormalities and cognitive test performance in MSA patients.
Time Frame: At inclusion (day 0)
At inclusion (day 0)
Actigraphy
Time Frame: During 7 days after inclusion

Sleep analysis :

Sleep / wake cycles and sleep fragmentation
During 7 days after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Investigators

  • Principal Investigator: Alexandra FOUBERT-SAMIER, MD, University Hospital, Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 14, 2014

Primary Completion (Actual)

June 25, 2015

Study Completion (Actual)

June 26, 2015

Study Registration Dates

First Submitted

July 1, 2014

First Submitted That Met QC Criteria

July 3, 2014

First Posted (Estimate)

July 9, 2014

Study Record Updates

Last Update Posted (Actual)

February 26, 2019

Last Update Submitted That Met QC Criteria

February 22, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2013/07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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