Comparative Investigation efficacy of cognitive rehabilitation and donepezil on memory, attention, quality of life and depression in patients with multiple sclerosis.
Objective: Comparative Investigation efficacy of cognitive rehabilitation and donepezil on memory, attention, quality of life and depression in patients with multiple sclerosis.
This clinical Trial with pretest-posttest plan is done in four groups and double blind for subjects and researchers. Statistical population of 80 patients with multiple sclerosis referred to MS clinics of Isfahan Kashani hospital that are available and were selected based on inclusion criteria. Allocation of subjects to four groups of 20 persons, including Group A (intervention with cognitive rehabilitation therapy), Group B (No any Intervention), Group C (Intervention with donepezil ) and group D (placebo) were random and after determining dysfunction cognitive patients by means of Autobiographical memory test, prospective and retrospective memory questionnaire, the Early Motor questionnaire, Digit span test for attention questionnaire, quality of life questionnaire and Beck for primary care questionnaire to determine the level of depression in the pre-test stage, for group A 20hours cognitive rehabilitation in 3 month period, for group C prescribed donepezil 10mg daily for 3 month and for group D placebo daily for 3 month is done. Then once again cognition status of subjects on four groups will analyze by using the above-mentioned questionnaire at post-test stage and compare the results of the intervention in groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016042227522N1
Registration date:2016-06-02, 1395/03/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-06-02, 1395/03/13
Registrant information
Name
Mohammad Mahdi Shahpouri
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3629 1050
Email address
shahpouri@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2016-05-30, 1395/03/10
Expected recruitment end date
2016-06-30, 1395/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative Investigation efficacy of cognitive rehabilitation and donepezil on memory, attention, quality of life and depression in patients with multiple sclerosis.
Public title
Comparative Investigation efficacy of cognitive rehabilitation and donepezil on memory, attention, quality of life and depression in patients with multiple sclerosis.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: definite diagnosis of MS according to the McDonald criteria by neurologist ; ability to participate in the interview and convey information and their experiences ; desire to participate in the study and necessary cooperation and motivation for interview ; absence of chronic disease other than multiple sclerosis ; age between 20 and 60 years ; having at least read and write education ; lack of renal and hepatic diseases ; non-use of anticholinergic drugs ; patients with Expanded Disability Status Scale up to 5/5 on the criteria of John Kurtzke ; patients with mild to moderate level of memory performance ; study of depression of subjects according to Beck for Primary Care questionnaire to verify the inclusion and omission of severe depression.
Exclusion criteria: loss of each conditions during the study inclusion ; lack of desire to continue this research collaboration ; inability to participate in therapy sessions regularly ; relapses of disease during the intervention period that lead to hospitalization in the hospital.
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Hezar Jerib St, Isfahan
City
Isfahan
Postal code
Approval date
2016-02-03, 1394/11/14
Ethics committee reference number
IR.MUI.REC.1395.3.1008
Health conditions studied
1
Description of health condition studied
Multiple Sclerosis
ICD-10 code
G35-G37
ICD-10 code description
Demyelinating diseases of the central nervous system
Primary outcomes
1
Description
Memory
Timepoint
Before Intervention & 3 month after Intervention
Method of measurement
Autobiographical Memory Test , The Prospective and Retrospective Memory Questionnaire , The Early Motor Questionnaire
2
Description
Attention
Timepoint
Before Intervention & 3 month after Intervention
Method of measurement
Digit Span Test
3
Description
Depression
Timepoint
Before Intervention & 3 month after Intervention
Method of measurement
Beck for Primary Care questionnaire
4
Description
Quality of Life
Timepoint
Before Intervention & 3 month after Intervention
Method of measurement
Quality of Life 54 questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1 : 20 hours Cognitive rehabilitation in 3 month period
Category
Rehabilitation
2
Description
Intervention group 2 : Tab Donepezil 10mg daily for 3 month
Category
Treatment - Drugs
3
Description
Intervention group 3 :Tab Placebo daily for 3 month
Category
Placebo
4
Description
Control group : No any Intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
MS Clinic of Isfahan Kashani Hospital
Full name of responsible person
Mohammad Mahdi Shahpouri
Street address
Kashani St, Isfahan, Iran
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor Of Rsearch, Isfahan University of Medical Sciences
Full name of responsible person
Dr Nematbakhsh
Street address
Hezar Jerib St, Isfahan University Of Medical Sciences, Isfahan, Iran
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor Of Rsearch, Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences , Neurosciences Research Center