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Cognitive Function in Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Cognitive function, cognitive reserve, functional capacity, reaction time, strength, fatigue, depression and general health assessment
Sponsored by
Inonu University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Multiple Sclerosis focused on measuring Multiple sclerosis, cognitive function, cognitive reserve, functional capacity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Relapsing-remitting MS diagnosis Expanded Disability Status Scale score <5.5 Being able to use a smart phone No relapse during the last 30 days Being between the ages of 18-65 Mini-Mental State Examination score>24 Exclusion Criteria: Severe Visual Impairment Severe Psychiatric Disorder, Severe Arthritis in Knee or Hip, Pregnancy and other neurological or vestibular disorders that may prevent the patient from completing the functional examination

Sites / Locations

  • Inonu University

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

Patient group

Control Group

Arm Description

Patients with a definite diagnosis of MS according to McDonald diagnostic criteria

Healthy individuals

Outcomes

Primary Outcome Measures

Functional capacity assessment
6-minute walk test were used. The 6-minute walk test requires patients to cover as much distance as possible in a six-minute period. The walking distance is recorded.
Functional capacity assessment
The STS-5 test, on the other hand, requires patients to perform five sit-stand cycles in a standard chair (0.43-m high and 0.45-m wide) as quickly as possible, measured in seconds, and is used as an indicator of lower extremity muscle strength.
Cognitive function
A mobile application called Trail Making Test was used to evaluate visual attention and cognitive flexibility. The completion time of subsections A and B was recorded. Working memory will be evaluated using a mobile application called Digit Span test. This application gives your maximum digit memory. This score has been saved.
Visiospatial perception
The visuospatial perception was evaluated with the help of the mobile application called Corsi Block Tapping test. The highest span in this application is recorded.
Cognitive Reserve Index Questionnaire
A tool used to quantify, in a standardized model, cognitive reserve through an interview to the participant or to the caregiver. The questionnaire collects demographic information regarding the school curriculum, work and type of free-time activities. These three different indices (CRI-School, CRI-Work and CRI-Free Time) are then combined into a single "Index of Cognitive Reserve".

Secondary Outcome Measures

Hand grip strength
Handgrip was measured with the Baseline Digital Hand Dynamometer 135 KG®. The results were recorded as Kg.
Nottingham Health Profile.
Nottingham Health Profile consists of 6 sections and a total of 38 questions evaluating patients' pain, emotional reaction, sleep, social isolation, physical activity and energy. In this questionnaire, where the highest score is 600 points, a high score is associated with a deterioration in quality of life
Beck Depression Inventory
The Beck Depression Inventory is a self-report measure of depression severity that is a well-characterized scale with excellent psychometric properties and is frequently used in research studies of depression. The scale measures symptoms related to sadness, pessimism, past failure, loss of pleasure, guilty feelings, punishment feelings, self-dislike, self-criticalness, suicidal thoughts or wishes, crying, agitation, loss of interest, indecisiveness, worthlessness, loss of energy, changes in sleeping pattern, irritability, changes in appetite, concentration difficulty, tiredness or fatigue, and loss of interest in sex. We report the total score on the Beck Depression Inventory, which has a range of 0 to 63. Higher values represent greater severity of depression. The following score interpretations are provided in the scale's manual: 0-9 minimal depression 10-18 mild depression 19-29 moderate depression 30-63 severe depression
Fatigue Severity Scale.
The fatigue severity scale is a short measurement tool consisting of nine questions developed by Krupp and used to measure the degree of fatigue in patients with multiple sclerosis. The validity and reliability of the scale Armutlu et al. and Cronbach's alpha coefficient was found to be 0.94. In the scale, individuals are asked to rate the fatigue they have felt during the past week from 1 to 7. Each section is scored between 1 (strongly disagree) and 7 (strongly agree). The total score is calculated by taking the average of nine items.
Reaction time
A mobile application called "Tap fast" was used. The patient is asked to touch the maximum number of boxes by touching the screen as quickly as possible within 15 seconds. The patient's score was recorded.

Full Information

First Posted
November 18, 2022
Last Updated
October 10, 2023
Sponsor
Inonu University
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1. Study Identification

Unique Protocol Identification Number
NCT06084182
Brief Title
Cognitive Function in Multiple Sclerosis
Official Title
The Relationship Between Cognitive Function and Functional Capacity, Cognitive Reserve, Reaction Time in Patients With Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
November 15, 2021 (Actual)
Primary Completion Date
July 15, 2022 (Actual)
Study Completion Date
November 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Inonu University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of the study is to investigate the relationship between cognitive function, functional capacity, cognitive reserve and reaction time in patients with multiple sclerosis.
Detailed Description
Cognitive impairment in patients with MS is a common problem that significantly affects quality of life. It shows an association between functional capacity and physical fitness levels and cognition in non-MS populations, and especially in the elderly. Although cognitive dysfunctions are known, few studies have been found on its relationship with secondary problems caused by the disease and its correlation with other symptoms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple sclerosis, cognitive function, cognitive reserve, functional capacity

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patient group
Arm Type
Other
Arm Description
Patients with a definite diagnosis of MS according to McDonald diagnostic criteria
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Healthy individuals
Intervention Type
Other
Intervention Name(s)
Cognitive function, cognitive reserve, functional capacity, reaction time, strength, fatigue, depression and general health assessment
Intervention Description
6-minute walk test and 5-time sit-to-stand test (STS-5) were used for functional capacity assessment. For cognitive reserve assessment, the Cognitive Reserve Index questionnaire was used. Reaction time, cognitive function and visiospatial perception were evaluated with the mobile application. In addition, the Fatigue Severity Scale; Beck Depression Questionnaire and Nottingham Health Profile were used.
Primary Outcome Measure Information:
Title
Functional capacity assessment
Description
6-minute walk test were used. The 6-minute walk test requires patients to cover as much distance as possible in a six-minute period. The walking distance is recorded.
Time Frame
Baseline
Title
Functional capacity assessment
Description
The STS-5 test, on the other hand, requires patients to perform five sit-stand cycles in a standard chair (0.43-m high and 0.45-m wide) as quickly as possible, measured in seconds, and is used as an indicator of lower extremity muscle strength.
Time Frame
baseline
Title
Cognitive function
Description
A mobile application called Trail Making Test was used to evaluate visual attention and cognitive flexibility. The completion time of subsections A and B was recorded. Working memory will be evaluated using a mobile application called Digit Span test. This application gives your maximum digit memory. This score has been saved.
Time Frame
Baseline
Title
Visiospatial perception
Description
The visuospatial perception was evaluated with the help of the mobile application called Corsi Block Tapping test. The highest span in this application is recorded.
Time Frame
Baseline
Title
Cognitive Reserve Index Questionnaire
Description
A tool used to quantify, in a standardized model, cognitive reserve through an interview to the participant or to the caregiver. The questionnaire collects demographic information regarding the school curriculum, work and type of free-time activities. These three different indices (CRI-School, CRI-Work and CRI-Free Time) are then combined into a single "Index of Cognitive Reserve".
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Hand grip strength
Description
Handgrip was measured with the Baseline Digital Hand Dynamometer 135 KG®. The results were recorded as Kg.
Time Frame
Baseline
Title
Nottingham Health Profile.
Description
Nottingham Health Profile consists of 6 sections and a total of 38 questions evaluating patients' pain, emotional reaction, sleep, social isolation, physical activity and energy. In this questionnaire, where the highest score is 600 points, a high score is associated with a deterioration in quality of life
Time Frame
Baseline
Title
Beck Depression Inventory
Description
The Beck Depression Inventory is a self-report measure of depression severity that is a well-characterized scale with excellent psychometric properties and is frequently used in research studies of depression. The scale measures symptoms related to sadness, pessimism, past failure, loss of pleasure, guilty feelings, punishment feelings, self-dislike, self-criticalness, suicidal thoughts or wishes, crying, agitation, loss of interest, indecisiveness, worthlessness, loss of energy, changes in sleeping pattern, irritability, changes in appetite, concentration difficulty, tiredness or fatigue, and loss of interest in sex. We report the total score on the Beck Depression Inventory, which has a range of 0 to 63. Higher values represent greater severity of depression. The following score interpretations are provided in the scale's manual: 0-9 minimal depression 10-18 mild depression 19-29 moderate depression 30-63 severe depression
Time Frame
Baseline
Title
Fatigue Severity Scale.
Description
The fatigue severity scale is a short measurement tool consisting of nine questions developed by Krupp and used to measure the degree of fatigue in patients with multiple sclerosis. The validity and reliability of the scale Armutlu et al. and Cronbach's alpha coefficient was found to be 0.94. In the scale, individuals are asked to rate the fatigue they have felt during the past week from 1 to 7. Each section is scored between 1 (strongly disagree) and 7 (strongly agree). The total score is calculated by taking the average of nine items.
Time Frame
Baseline
Title
Reaction time
Description
A mobile application called "Tap fast" was used. The patient is asked to touch the maximum number of boxes by touching the screen as quickly as possible within 15 seconds. The patient's score was recorded.
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Relapsing-remitting MS diagnosis Expanded Disability Status Scale score <5.5 Being able to use a smart phone No relapse during the last 30 days Being between the ages of 18-65 Mini-Mental State Examination score>24 Exclusion Criteria: Severe Visual Impairment Severe Psychiatric Disorder, Severe Arthritis in Knee or Hip, Pregnancy and other neurological or vestibular disorders that may prevent the patient from completing the functional examination
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Engin Ramazanoglu
Organizational Affiliation
Inonu University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mehmet Tecellioglu
Organizational Affiliation
Inonu University
Official's Role
Study Chair
Facility Information:
Facility Name
Inonu University
City
Malatya
Country
Turkey

12. IPD Sharing Statement

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Cognitive Function in Multiple Sclerosis

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