UMIN-CTR Clinical Trial

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

Multiple Sclerosis

Classification by specialty

Neurology

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

Performance at the Game of Dice Task and the Iowa Gambling Task

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

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

Institute

Department

Personal name

Organization

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

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2013

Year

07

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

Registered date

2013

Year

02

Month

25

Day

Last modified on

2013

Year

02

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011796