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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010118
Receipt No. R000011796
Scientific Title Decision-making impairment in patients with Multiple Sclerosis
Date of disclosure of the study information 2013/07/01
Last modified on 2013/02/25

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Basic information
Public title Decision-making impairment in patients with Multiple Sclerosis
Acronym Decision-making impairment in Multiple Sclerosis
Scientific Title Decision-making impairment in patients with Multiple Sclerosis
Scientific Title:Acronym Decision-making impairment in Multiple Sclerosis
Region
South America

Condition
Condition Multiple Sclerosis
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess decision-making under explicit risk conditions in relapsing-remitting multiple sclerosis patients and its relationship to decisions taken under conditions of ambiguity. To assess cognitive functions related to decision-making performance in MS patients.
Basic objectives2 Others
Basic objectives -Others To evaluate decision-making in multiple sclerosis patients
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Performance at the Game of Dice Task and the Iowa Gambling Task
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit
50 years-old >=
Gender Male and Female
Key inclusion criteria Diagnosis of multiple sclerosis according to McDonald criteria.
Key exclusion criteria No history of psychiatric illness, no history of substance abuse.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mauricio Farez
Organization Raul Carrea Institute for Neurological Research (FLENI), Buenos Aires, Argentina.
Division name Neuroimmunology Department
Zip code
Address Montaneses 2325, Buenos Aires (1428), Argentina.
TEL 541157773200
Email

Public contact
Name of contact person
1st name
Middle name
Last name Mauricio Farez
Organization Raul Carrea Institute for Neurological Research (FLENI), Buenos Aires, Argentina.
Division name Neuroimmunology Department
Zip code
Address Montan;eses 2325, Buenos Aires (1428), Argentina.
TEL 541157773200
Homepage URL
Email mauriciofarez@gmail.com

Sponsor
Institute Raul Carrea Institute for Neurological Research (FLENI), Buenos Aires, Argentina.
Institute
Department

Funding Source
Organization Raul Carrea Institute for Neurological Research (FLENI), Buenos Aires, Argentina.
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2013 Year 07 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2011 Year 02 Month 15 Day
Date of IRB
Anticipated trial start date
2011 Year 02 Month 16 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Objectives. To assess decision-making under explicit risk conditions in relapsing-remitting multiple sclerosis patients and its relationship to decisions taken under conditions of ambiguity. To assess cognitive functions related to decision-making performance in MS patients. Methods. Twenty-seven patients with relapsing-remitting multiple sclerosis and 27 sex-, age- and education-matched healthy controls underwent extensive neuropsychological assessment and decision-making evaluation using the Game of Dice Task and the Iowa Gambling Task. Results. MS patients showed significantly poorer performance on Game of Dice Task, choosing disadvantageous dice more often (P=0.019), as well as significantly lower overall scores in the Iowa Gambling Task (P=0.007). Block analysis showed MS patients and controls scores were comparable for blocks 1 and 2 (P=0.15 and P=0.24, respectively). Conversely, MS patients scored poorly on blocks 4 (P=0.003) and 5 (P=0.023), the last two of the test, corresponding to decision-making under conditions of risk. Finally, Game of Dice Task performance together with the last 3 blocks of the Iowa Gambling Task were correlated with visuo-spatial learning, processing speed and working memory but not with executive functioning. Conclusions. MS patients showed deficits in decision-making under risk conditions, which might be related to deficits in visuo-spatial learning, processing speed and working memory.

Management information
Registered date
2013 Year 02 Month 25 Day
Last modified on
2013 Year 02 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011796

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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