Multiple System AtrophyCogAMSNCT02185677
Cognitive and Behavioral Dysexecutive Syndrome in Multiple System Atrophy
An observational study of Multiple System Atrophy, run by University Hospital, Bordeaux at 1 site in France.
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 . Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Multiple System Atrophy
- What is being tested?
- Clinical evaluation, neuropsychological battery test and MRI
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 14 May 2014to 26 Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients suffering from MSA-P or MSA-C
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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 .
Read the 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.
- Conditions
- Multiple System Atrophy
- Being tested
- Clinical evaluation, neuropsychological battery test, MRI, Actigraphy
- Keywords
- dysexecutive syndrome, multiple system atrophy, imaging study
- Medical subject headings
- Multiple System Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical evaluationOther
neuropsychological battery testOther
MRIOther
ActigraphyOther
Actigraphy recording will be performed during 7 days after inclusion.
| Study group | Role | What they receive |
|---|---|---|
| MSA-P | Not described Receives: Other: Clinical evaluation; Other: neuropsychological battery test; Other: MRI; Other: Actigraphy | |
| MSA-C | Not described Receives: Other: Clinical evaluation; Other: neuropsychological battery test; Other: MRI; Other: Actigraphy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioral Dysexecutive Syndrome Inventory scores
Measured: At inclusion (day 0)
Secondary outcomes (6)
To compare the subscores of the BDSI between MSA-P patients and MSA-C patients.
Measured: At inclusion (Day 0)
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
Measured: At inclusion (Day 0)
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
Measured: 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.
Measured: At inclusion (Day 0)
To research correlations between imaging abnormalities and cognitive test performance in MSA patients.
Measured: At inclusion (day 0)
Actigraphy
Sleep analysis :
Sleep / wake cycles and sleep fragmentation
Measured: During 7 days after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2014 (estimated)
- Study start14 May 2014
- Primary completion25 Jun 2015
- Study completion26 Jun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple System AtrophyStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandra FOUBERT-SAMIER, MD, Principal investigator, University Hospital, BordeauxRodolphe THIEBAUT, MD, PhD, Study chair, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02185677
- Sponsor's protocol ID
- CHUBX 2013/07
- Acronym
- CogAMS
- Status last verified
- Feb 2019
- First submitted
- 1 Jul 2014
- Last updated
- 26 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02185677
- Acronym / sponsor ID
- CogAMS / CHUBX 2013/07
- Conditions
- Multiple System Atrophy
- Keywords
- dysexecutive syndrome, multiple system atrophy, imaging study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 14 May 2014 (actual)
- Primary completion
- 25 Jun 2015 (actual)
- Study completion
- 26 Jun 2015 (actual)
- First posted
- 9 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MSA-P | – | Other: Clinical evaluation, Other: neuropsychological battery test, Other: MRI, Other: Actigraphy |
| MSA-C | – | Other: Clinical evaluation, Other: neuropsychological battery test, Other: MRI, Other: Actigraphy |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from MSA-P or MSA-C
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical evaluation | Other | MSA-C, MSA-P |
| neuropsychological battery test | Other | MSA-C, MSA-P |
| MRI | Other | MSA-C, MSA-P |
| ActigraphyActigraphy recording will be performed during 7 days after inclusion. | Other | MSA-C, MSA-P |
Primary outcome
Behavioral Dysexecutive Syndrome Inventory scores
Time frame: At inclusion (day 0)
6 secondary outcomes
To compare the subscores of the BDSI between MSA-P patients and MSA-C patients.
Time frame: 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)
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)
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)
To research correlations between imaging abnormalities and cognitive test performance in MSA patients.
Time frame: At inclusion (day 0)
Actigraphy
Time frame: During 7 days after inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandra FOUBERT-SAMIER, MD principal investigator
University Hospital, Bordeaux
Rodolphe THIEBAUT, MD, PhD study chair
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple System Atrophy, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavioral Dysexecutive Syndrome Inventory scores (time frame: At inclusion (day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2019.