NCT02185677

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 .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 14, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 9, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2015

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2015

Completed
Last Updated

February 26, 2019

Status Verified

February 1, 2019

Enrollment Period

1.1 years

First QC Date

July 1, 2014

Last Update Submit

February 22, 2019

Conditions

Multiple System Atrophy

Keywords

dysexecutive syndromemultiple system atrophyimaging study

Outcome Measures

Primary Outcomes (1)

  • Behavioral Dysexecutive Syndrome Inventory scores

    At inclusion (day 0)

Secondary Outcomes (6)

  • To compare the subscores of the BDSI between MSA-P patients and MSA-C patients.

    At inclusion (Day 0)

  • To compare the cognitive tests exploring the cognitive dysexecutive syndrome between MSA-P patients and MSA-C patients.

    At inclusion (Day 0)

  • To research correlations between scores UMSARS and cognitive and behavioral scores for MSA-P patients and MSA-C patients.

    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.

    At inclusion (Day 0)

  • To research correlations between imaging abnormalities and cognitive test performance in MSA patients.

    At inclusion (day 0)

  • +1 more secondary outcomes

Study Arms (2)

MSA-P

Other: Clinical evaluationOther: neuropsychological battery testOther: MRIOther: Actigraphy

MSA-C

Other: Clinical evaluationOther: neuropsychological battery testOther: MRIOther: Actigraphy

Interventions

Clinical evaluationOTHER
MSA-CMSA-P
neuropsychological battery testOTHER
MSA-CMSA-P
MRIOTHER
MSA-CMSA-P
ActigraphyOTHER

Actigraphy recording will be performed during 7 days after inclusion.

MSA-CMSA-P

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients suffering from MSA-P or MSA-C

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Bordeaux

Bordeaux, 33000, France

Location

MeSH Terms

Conditions

Multiple System Atrophy

Interventions

Actigraphy

Condition Hierarchy (Ancestors)

Primary DysautonomiasAutonomic Nervous System DiseasesNervous System DiseasesBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Monitoring, PhysiologicDiagnostic Techniques and ProceduresDiagnosisAccelerometryInvestigative Techniques

Study Officials

  • Alexandra FOUBERT-SAMIER, MD

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

  • Rodolphe THIEBAUT, MD, PhD

    University Hospital, Bordeaux

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2014

First Posted

July 9, 2014

Study Start

May 14, 2014

Primary Completion

June 25, 2015

Study Completion

June 26, 2015

Last Updated

February 26, 2019

Record last verified: 2019-02

Locations

FR(1)