MS (Multiple Sclerosis)NCT07831239
Association Between Peripheral Immune Biomarkers and Functional Performance in Multiple Sclerosis
An observational study of MS (Multiple Sclerosis), run by Halic University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this observational study is to investigate whether certain substances in the blood associated with the immune system are linked to the physical and mental abilities of individuals with multiple sclerosis. Read more about this study
- Who is it for?
- Ages 19 to 45 years
- Conditions the study is for
- MS (Multiple Sclerosis)
- What is being tested?
- Peripheral Immune Biomarkers
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2026to 30 Jul 2026
- 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 19 to 45 years
- All sexes
- No healthy volunteers
- Adult
Study population: Adults with multiple sclerosis who underwent baseline assessment of functional performance and peripheral immune biomarkers.
Who may be able to join
- MS patients aged 19-45 who have been diagnosed with Relapsing-Remitting Multiple Sclerosis (RRMS), are not receiving steroid therapy, and have an Expanded Disability Status Scale (EDSS) score of 0.5-3.5.
Who cannot join
- Those with a high level of physical activity; those experiencing an acute MS relapse or with a history of relapse within the last 3 months; those with orthopedic or systemic problems preventing participation in exercise; those with a known neuromuscular or immune disorder other than MS; those who started immunomodulatory therapy within the last 6 months; those with visual involvement or diplopia; those with severe lower-extremity spasticity (Modified Ashworth Scale score of 3 or 4); those with cardiopulmonary problems preventing participation in exercise.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Van Regional Training and Research Hospital
Van, 65100
About this study
Official title: ASSOCIATION BETWEEN PERIPHERAL IMMUNE BIOMARKERS AND FUNCTIONAL PERFORMANCE IN PATIENTS WITH MULTIPLE SCLEROSIS
The aim of this observational study is to investigate whether certain substances in the blood associated with the immune system are linked to the physical and mental abilities of individuals with multiple sclerosis. The study will examine the relationship of these substances with walking, hand coordination, cognitive skills, and functional loss resulting from the disease. Blood samples will be collected from participants, and simple tests assessing walking, hand coordination, and cognitive skills will be administered.
Read the detailed description
This is an observational, cross-sectional study investigating the relationship between peripheral immune biomarkers and functional performance in patients with multiple sclerosis (MS). The study is designed to determine whether selected peripheral immune biomarkers are associated with functional performance and disability-related measures in individuals with MS.
Participants with a diagnosis of multiple sclerosis will be evaluated using clinical, demographic, functional, and laboratory measurements. The study includes 20 patients with multiple sclerosis. Data were collected between June 1, 2026 and July 30, 2026. All assessments were performed using baseline data, and no therapeutic or exercise intervention was administered as part of this study.
Peripheral immune biomarkers evaluated in the study include tumor necrosis factor-alpha (TNF-α), interleukin-8 (IL-8/CXCL8), and adiponectin. These biomarkers will be examined in relation to measures of functional performance.
Functional performance will be assessed using the Multiple Sclerosis Functional Composite (MSFC) and its components, including the Timed 25-Foot Walk test, the Nine-Hole Peg Test, and the Paced Auditory Serial Addition Test (PASAT). The results of the individual MSFC components will also be evaluated separately. Disability status will be assessed using the Expanded Disability Status Scale (EDSS).
Demographic and clinical characteristics, including age, sex, body mass index, and disease duration, will also be recorded. These characteristics will be considered when describing the study population and evaluating the relationship between immune biomarkers and functional performance.
The primary objective of the study is to investigate the association between peripheral immune biomarker levels and functional performance in patients with multiple sclerosis. The secondary objective is to examine the associations between individual immune biomarkers and the individual components of the MSFC, as well as disability status assessed by the EDSS.
The study uses an observational correlational design. Associations between continuous variables will be evaluated using appropriate correlation analyses based on the distribution and characteristics of the data. The study does not involve assignment to an intervention group, administration of an investigational treatment, or modification of participants' usual clinical care.
- Conditions
- MS (Multiple Sclerosis)
- Being tested
- Peripheral Immune Biomarkers
- Keywords
- Multiple Sclerosis,Immune Biomarkers,Tumor Necrosis Factor-alpha,Interleukin-8,Adiponectin,Multiple Sclerosis Functional Composite
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral Immune BiomarkersOther
Peripheral immune biomarkers, including tumor necrosis factor-alpha, interleukin-8 (IL-8/CXCL8), and adiponectin, were measured in serum samples collected at baseline. No therapeutic intervention was administered as part of this observational study.
| Study group | Role | What they receive |
|---|---|---|
| Multiple sclerosis participants | Participants with multiple sclerosis who were evaluated to examine the relationship between peripheral immune biomarkers and functional performance. Receives: Other: Peripheral Immune Biomarkers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multiple Sclerosis Functional Composite (MSFC)
The Multiple Sclerosis Functional Composite (MSFC) is a standardized measure of functional performance in people with multiple sclerosis. It includes walking ability, hand coordination, and cognitive processing speed.
Measured: At baseline (study enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start1 Jun 2026
- Primary completion30 Jul 2026
- Study completion30 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MS (Multiple Sclerosis)Studies 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Halic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berna Calp, Halic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07831239
- Sponsor's protocol ID
- KAD-FR-43
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers because the data contain potentially identifiable participant information and are subject to ethical and privacy considerations.
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASSOCIATION BETWEEN PERIPHERAL IMMUNE BIOMARKERS AND FUNCTIONAL PERFORMANCE IN PATIENTS WITH MULTIPLE SCLEROSIS
- ClinicalTrials.gov ID
- NCT07831239
- Acronym / sponsor ID
- KAD-FR-43
- Conditions
- MS (Multiple Sclerosis)
- Keywords
- Multiple Sclerosis,Immune Biomarkers,Tumor Necrosis Factor-alpha,Interleukin-8,Adiponectin,Multiple Sclerosis Functional Composite
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Halic UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 30 Jul 2026 (actual)
- Study completion
- 30 Jul 2026 (actual)
- First posted
- 21 Sep 2026 (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 this observational study is to investigate whether certain substances in the blood associated with the immune system are linked to the physical and mental abilities of individuals with multiple sclerosis. The study will examine the relationship of these substances with walking, hand coordination, cognitive skills, and functional loss resulting from the disease. Blood samples will be collected from participants, and simple tests assessing walking, hand coordination, and cognitive skills will be administered.
Detailed description
This is an observational, cross-sectional study investigating the relationship between peripheral immune biomarkers and functional performance in patients with multiple sclerosis (MS). The study is designed to determine whether selected peripheral immune biomarkers are associated with functional performance and disability-related measures in individuals with MS.
Participants with a diagnosis of multiple sclerosis will be evaluated using clinical, demographic, functional, and laboratory measurements. The study includes 20 patients with multiple sclerosis. Data were collected between June 1, 2026 and July 30, 2026. All assessments were performed using baseline data, and no therapeutic or exercise intervention was administered as part of this study.
Peripheral immune biomarkers evaluated in the study include tumor necrosis factor-alpha (TNF-α), interleukin-8 (IL-8/CXCL8), and adiponectin. These biomarkers will be examined in relation to measures of functional performance.
Functional performance will be assessed using the Multiple Sclerosis Functional Composite (MSFC) and its components, including the Timed 25-Foot Walk test, the Nine-Hole Peg Test, and the Paced Auditory Serial Addition Test (PASAT). The results of the individual MSFC components will also be evaluated separately. Disability status will be assessed using the Expanded Disability Status Scale (EDSS).
Demographic and clinical characteristics, including age, sex, body mass index, and disease duration, will also be recorded. These characteristics will be considered when describing the study population and evaluating the relationship between immune biomarkers and functional performance.
The primary objective of the study is to investigate the association between peripheral immune biomarker levels and functional performance in patients with multiple sclerosis. The secondary objective is to examine the associations between individual immune biomarkers and the individual components of the MSFC, as well as disability status assessed by the EDSS.
The study uses an observational correlational design. Associations between continuous variables will be evaluated using appropriate correlation analyses based on the distribution and characteristics of the data. The study does not involve assignment to an intervention group, administration of an investigational treatment, or modification of participants' usual clinical care.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multiple sclerosis participants | – | Other: Peripheral Immune BiomarkersParticipants with multiple sclerosis who were evaluated to examine the relationship between peripheral immune biomarkers and functional performance. |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Adults with multiple sclerosis who underwent baseline assessment of functional performance and peripheral immune biomarkers.
Key inclusion criteria (1 listed)
- MS patients aged 19-45 who have been diagnosed with Relapsing-Remitting Multiple Sclerosis (RRMS), are not receiving steroid therapy, and have an Expanded Disability Status Scale (EDSS) score of 0.5-3.5.
Key exclusion criteria (1 listed)
- Those with a high level of physical activity; those experiencing an acute MS relapse or with a history of relapse within the last 3 months; those with orthopedic or systemic problems preventing participation in exercise; those with a known neuromuscular or immune disorder other than MS; those who started immunomodulatory therapy within the last 6 months; those with visual involvement or diplopia; those with severe lower-extremity spasticity (Modified Ashworth Scale score of 3 or 4); those with cardiopulmonary problems preventing participation in exercise.
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 |
|---|---|---|
| Peripheral Immune BiomarkersPeripheral immune biomarkers, including tumor necrosis factor-alpha, interleukin-8 (IL-8/CXCL8), and adiponectin, were measured in serum samples collected at baseline. No therapeutic intervention was administered as part of this observational study. | Other | Multiple sclerosis participants |
Primary outcome
Multiple Sclerosis Functional Composite (MSFC)
Time frame: At baseline (study enrollment)
The Multiple Sclerosis Functional Composite (MSFC) is a standardized measure of functional performance in people with multiple sclerosis. It includes walking ability, hand coordination, and cognitive processing speed.
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 21 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers because the data contain potentially identifiable participant information and are subject to ethical and privacy considerations.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 MS (Multiple Sclerosis), run by Halic 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 1 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 21 Sep 2026. 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?
Multiple Sclerosis Functional Composite (MSFC) (time frame: At baseline (study enrollment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Sep 2026.