Multiple SclerosisNCT03594357
Cognitive Functions in Patients With Multiple Sclerosis
An observational study of Multiple Sclerosis, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
Approximately 65% of multiple sclerosis (MS) patients appear to have problems in their cognitive function. Long-term memory is one of the most frequently affected functions in MS patients. Many factors play a role in the deterioration of cognitive functions because of many symptoms of MS. 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
- How many people
- 137 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Sep 2018to 24 Dec 2018
- Phase
- Observational
- 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
Study population: MS patients who apply to the Neurological Rehabilitation Unit of Gazi University Faculty of Health Sciences will be invited to this study.
Who may be able to join
- Participants who 18-65 years of age
- MS patients who are ambulatory (Expanded Disability Status Scale score ≤ 5,5 ) in a stable phase of the disease, without relapses in the last 3 month.
Who cannot join
- Participants who have orthopedic, vision, hearing, or perception problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Relationship of Cognitive Functions to Physical and Personal Factors in Patients With Multiple Sclerosis
Approximately 65% of multiple sclerosis (MS) patients appear to have problems in their cognitive function. Long-term memory is one of the most frequently affected functions in MS patients. Many factors play a role in the deterioration of cognitive functions because of many symptoms of MS.
The aim of this study is to investigate the relationship of cognitive function with physical factors such as balance, functional exercise capacity and personal factors such as fatigue level, mood, sleep quality in patients with MS.
Read the detailed description
Patients with MS between 0-5,5 score according to the Extended Disability Status Scale (EDSS) and healthy individuals of similar age and sex to patients will be included in the study. The cognitive function, balance, functional exercise capacity, fatigue, mood, sleep quality will be evaluated once.
Investigators will use descriptive statistics and t-tests to compare variables between groups. Investigators will examine the correlations between variables using Pearson bivariate correlations. The significance level is set at p<0,05.
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple sclerosis, Balance, Cognition, Functional exercise capacity, Fatigue, Sleep quality
- Medical subject headings
- Multiple Sclerosis, Fatigue, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Multiple sclerosis | MS patients (EDSS: 0-5,5) | |
| Control | Healthy individuals without chronic disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
cognitive function
The Brief Repeatable Battery of Neuropsychological Tests will be used. The Brief Repeatable Battery of Neuropsychological Tests (BRB-N) consists of the selective reminding, 10/36 spatial recall, symbol digit modalities, paced auditory serial addition (PASAT) and word list generation tests.
Measured: baseline
Secondary outcomes (5)
Balance
The posturography (Biodex Balance System-BioSwayTM) will be used to assess postural sway and sensory interaction. The participants will be asked to stand on both feet for 30 seconds under altered sensory conditions. The four conditions are as follows: 1. Eyes open-firm surface, 2. Eyes closed-firm surface; 3. Eyes open-foam surface, 4. Eyes closed-foam surface. Each test was repeated 3 times and the overall score was recorded.
Measured: baseline
Functional exercise capacity.
The Six-Minute Walking Test (6-MWT) will be performed to determine the functional exercise capacity. The heart rate, blood pressure and fatigue severity of the participants are recorded before and after the test. The heart rate is assessed by a heart rate monitor and fatigue severity is assessed by the Modified Borg Scale. The participants are asked to walk as far as possible for 6 minutes in a 30-meter corridor. Finally, the walking distance will be recorded in meters.
Measured: baseline
Fatigue
Fatigue impact scale will be used to assess fatigue. There are 40 items, each of which is scored 0 (no problem) to 4 (extreme problem), providing a continuous scale of 0-160. It is composed of three subscales that describe how fatigue impacts upon cognitive (10 items), physical (10 items) and psychosocial functioning (10 items). Cognitive functioning concerns concentration, memory, thinking and organization of thoughts. Physical functioning reflects motivation, effort, stamina and coordination. Psychosocial functioning describes the impact of fatigue upon isolation, emotions, workload and coping.A higher score indicates a higher fatigue impact.
Measured: baseline
Mood
Beck's Depression Inventory will be used to assess mood. The 21-item self-administered survey is scored on a scale of 0-3 in a list of four statements arranged in increasing severity about a particular symptom of depression. The highest possible total for the whole test would be sixty-three. A higher score indicates a higher depression.
Measured: baseline
Sleep Quality
The Pittsburgh Sleep Quality Index (PSQI) is an effective instrument used to measure the quality and patterns of sleep in adults. It differentiates "poor" from "good" sleep quality by measuring seven areas (components): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction over the last month. A total score of "5" or greater is indicative of poor sleep quality.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2018
- Study start3 Sep 2018
- Primary completion21 Dec 2018
- Study completion24 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cagla Ozkul, Gazi University
- Investigators
- Cagla Ozkul, Principal investigator, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03594357
- Sponsor's protocol ID
- 437
- Status last verified
- Jan 2019
- First submitted
- 9 Jul 2018
- Last updated
- 30 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rao SM, Leo GJ, Bernardin L, Unverzagt F. Cognitive dysfunction in multiple sclerosis. I. Frequency, patterns, and prediction. Neurology. 1991 May;41(5):685-91. doi: 10.1212/wnl.41.5.685.
PubMed 2027484Rao SM, Grafman J, DiGuilio D, et al. Memory dysfunction in multiple sclerosis: its relation toworking memory, semantic encoding and implicit learning.Neuropsychology 1993; 7:364-374
Amato MP, Zipoli V, Portaccio E. Multiple sclerosis-related cognitive changes: a review of cross-sectional and longitudinal studies. J Neurol Sci. 2006 Jun 15;245(1-2):41-6. doi: 10.1016/j.jns.2005.08.019. Epub 2006 Apr 27.
PubMed 16643953Lynch SG, Parmenter BA, Denney DR. The association between cognitive impairment and physical disability in multiple sclerosis. Mult Scler. 2005 Aug;11(4):469-76. doi: 10.1191/1352458505ms1182oa.
PubMed 16042232Sandroff BM, Pilutti LA, Benedict RH, Motl RW. Association between physical fitness and cognitive function in multiple sclerosis: does disability status matter? Neurorehabil Neural Repair. 2015 Mar-Apr;29(3):214-23. doi: 10.1177/1545968314541331. Epub 2014 Jul 8.
PubMed 25009224
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship of Cognitive Functions to Physical and Personal Factors in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT03594357
- Acronym / sponsor ID
- 437
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple sclerosis, Balance, Cognition, Functional exercise capacity, Fatigue, Sleep quality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 3 Sep 2018 (actual)
- Primary completion
- 21 Dec 2018 (actual)
- Study completion
- 24 Dec 2018 (actual)
- First posted
- 20 Jul 2018 (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.
Approximately 65% of multiple sclerosis (MS) patients appear to have problems in their cognitive function. Long-term memory is one of the most frequently affected functions in MS patients. Many factors play a role in the deterioration of cognitive functions because of many symptoms of MS.
The aim of this study is to investigate the relationship of cognitive function with physical factors such as balance, functional exercise capacity and personal factors such as fatigue level, mood, sleep quality in patients with MS.
Detailed description
Patients with MS between 0-5,5 score according to the Extended Disability Status Scale (EDSS) and healthy individuals of similar age and sex to patients will be included in the study. The cognitive function, balance, functional exercise capacity, fatigue, mood, sleep quality will be evaluated once.
Investigators will use descriptive statistics and t-tests to compare variables between groups. Investigators will examine the correlations between variables using Pearson bivariate correlations. The significance level is set at p<0,05.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multiple sclerosis | – | –MS patients (EDSS: 0-5,5) |
| Control | – | –Healthy individuals without chronic disease |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- MS patients who apply to the Neurological Rehabilitation Unit of Gazi University Faculty of Health Sciences will be invited to this study.
Key inclusion criteria (2 listed)
- Participants who 18-65 years of age
- MS patients who are ambulatory (Expanded Disability Status Scale score ≤ 5,5 ) in a stable phase of the disease, without relapses in the last 3 month.
Key exclusion criteria (1 listed)
- Participants who have orthopedic, vision, hearing, or perception problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
cognitive function
Time frame: baseline
The Brief Repeatable Battery of Neuropsychological Tests will be used. The Brief Repeatable Battery of Neuropsychological Tests (BRB-N) consists of the selective reminding, 10/36 spatial recall, symbol digit modalities, paced auditory serial addition (PASAT) and word list generation tests.
5 secondary outcomes
Balance
Time frame: baseline
Functional exercise capacity.
Time frame: baseline
Fatigue
Time frame: baseline
Mood
Time frame: baseline
Sleep Quality
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 30 Jan 2019.
- Background: PubMed 2027484Rao SM, Leo GJ, Bernardin L, Unverzagt F. Cognitive dysfunction in multiple sclerosis. I. Frequency, patterns, and prediction. Neurology. 1991 May;41(5):685-91. doi: 10.1212/wnl.41.5.685.
- BackgroundRao SM, Grafman J, DiGuilio D, et al. Memory dysfunction in multiple sclerosis: its relation toworking memory, semantic encoding and implicit learning.Neuropsychology 1993; 7:364-374
- Background: PubMed 16643953Amato MP, Zipoli V, Portaccio E. Multiple sclerosis-related cognitive changes: a review of cross-sectional and longitudinal studies. J Neurol Sci. 2006 Jun 15;245(1-2):41-6. doi: 10.1016/j.jns.2005.08.019. Epub 2006 Apr 27.
- Background: PubMed 16042232Lynch SG, Parmenter BA, Denney DR. The association between cognitive impairment and physical disability in multiple sclerosis. Mult Scler. 2005 Aug;11(4):469-76. doi: 10.1191/1352458505ms1182oa.
- Background: PubMed 25009224Sandroff BM, Pilutti LA, Benedict RH, Motl RW. Association between physical fitness and cognitive function in multiple sclerosis: does disability status matter? Neurorehabil Neural Repair. 2015 Mar-Apr;29(3):214-23. doi: 10.1177/1545968314541331. Epub 2014 Jul 8.
- Individual participant dataSharing planned: No
Related trials for Multiple Sclerosis
RecruitingPhase 1
A Study to Assess the Safety and Clinical Activity of Azer-cel in Participants With B-cell Mediated Autoimmune Disorders
B-cell Mediated Autoimmune Disorders
RecruitingPhase 2
A Study to Evaluate the Efficacy, Safety and Tolerability of BMS-986368 in Participants With Multiple Sclerosis Spasticity
Multiple Sclerosis Spasticity
RecruitingPhase 3
A Study of Orelabrutinib in Patients With Primary Progressive Multiple Sclerosis
Multiple Sclerosis (MS) Primary Progressive
Active, not recruiting
Tai Chi Training for Persons With Multiple Sclerosis.
Multiple Sclerosis (MS) - Relapsing-remitting
RecruitingPhase 3
A Study of Orelabrutinib in Patients With Secondary Progressive Multiple Sclerosis
Secondary Progressive Multiple Sclerosis
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.
Cagla Ozkul principal investigator
Gazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Gazi 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 2 inclusion and 1 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 30 Jan 2019. 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?
cognitive function (time frame: baseline). 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 NCT03594357, which also lists 5 linked publications.
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 30 Jan 2019.