Multiple SclerosisNCT06084182
Cognitive Function in Multiple Sclerosis
A study testing Cognitive function, cognitive reserve, functional capacity, reaction time, strength, fatigue, depression and general health assessment in people with Multiple Sclerosis, run by Inonu University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Cognitive function, cognitive reserve, functional capacity, reaction time, strength, fatigue, depression and general health assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2021to 15 Nov 2022
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Relationship Between Cognitive Function and Functional Capacity, Cognitive Reserve, Reaction Time in Patients With Multiple Sclerosis
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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Cognitive function, cognitive reserve, functional capacity, reaction time, strength, fatigue, depression and general health assessment
- Keywords
- Multiple sclerosis, cognitive function, cognitive reserve, functional capacity
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive function, cognitive reserve, functional capacity, reaction time, strength, fatigue, depression and general health assessmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patient group | Other | Patients with a definite diagnosis of MS according to McDonald diagnostic criteria Receives: Other: Cognitive function, cognitive reserve, functional capacity, reaction time, strength, fatigue, depression and general health assessment |
| Control Group | No intervention | Healthy individuals |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
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.
Measured: baseline
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.
Measured: Baseline
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.
Measured: Baseline
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".
Measured: Baseline
Secondary outcomes (5)
Hand grip strength
Handgrip was measured with the Baseline Digital Hand Dynamometer 135 KG®. The results were recorded as Kg.
Measured: Baseline
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
Measured: Baseline
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
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study start15 Nov 2021
- Primary completion15 Jul 2022
- Study completion15 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burcu Talu, Inonu University
- Investigators
- Engin Ramazanoglu, Study chair, Inonu UniversityMehmet Tecellioglu, Study chair, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06084182
- Sponsor's protocol ID
- 2021/2611
- Status last verified
- Oct 2023
- First submitted
- 18 Nov 2022
- Last updated
- 16 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Candiri B, Ramazanoglu E, Talu B, Tecellioglu M. The relationship between cognitive function and functional capacity, and cognitive reserve and reaction time in patients with multiple sclerosis. Arq Neuropsiquiatr. 2024 Sep;82(9):1-9. doi: 10.1055/s-0044-1788273. Epub 2024 Aug 26.
PubMed 39187267
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Cognitive Function and Functional Capacity, Cognitive Reserve, Reaction Time in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT06084182
- Acronym / sponsor ID
- 2021/2611
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple sclerosis, cognitive function, cognitive reserve, functional capacity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 15 Nov 2022 (actual)
- First posted
- 16 Oct 2023 (actual)
- 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 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient group | Other | Other: Cognitive function, cognitive reserve, functional capacity, reaction time, strength, fatigue, depression and general health assessmentPatients with a definite diagnosis of MS according to McDonald diagnostic criteria |
| Control Group | No intervention | –Healthy individuals |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Cognitive function, cognitive reserve, functional capacity, reaction time, strength, fatigue, depression and general health assessment6-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. | Other | Patient group |
Primary outcome
Functional capacity assessment
Time frame: Baseline
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
Time frame: baseline
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
Time frame: Baseline
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
Time frame: Baseline
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
Time frame: Baseline
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".
5 secondary outcomes
Hand grip strength
Time frame: Baseline
Nottingham Health Profile.
Time frame: Baseline
Beck Depression Inventory
Time frame: Baseline
Fatigue Severity Scale.
Time frame: Baseline
Reaction time
Time frame: Baseline
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 16 Oct 2023.
- Derived from this study: PubMed 39187267Candiri B, Ramazanoglu E, Talu B, Tecellioglu M. The relationship between cognitive function and functional capacity, and cognitive reserve and reaction time in patients with multiple sclerosis. Arq Neuropsiquiatr. 2024 Sep;82(9):1-9. doi: 10.1055/s-0044-1788273. Epub 2024 Aug 26.
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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.
Engin Ramazanoglu study chair
Inonu University
Mehmet Tecellioglu study chair
Inonu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive function, cognitive reserve, functional capacity, reaction time, strength, fatigue, depression and general health assessment in people with Multiple Sclerosis, run by Inonu University at 1 site in Turkey (Türkiye).
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 4 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 16 Oct 2023. 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 Turkey (Türkiye). 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?
Functional capacity assessment (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06084182, which also lists 1 linked publication.
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 16 Oct 2023; AzTrials last refreshed its copy on 3 Nov 2026.