Relapsing Remitting Multiple SclerosisNCT05604092
Lesion Load and Location in Relation to Cognition, Fatigue and Physical Disability in RRMS
An observational study of Relapsing Remitting Multiple Sclerosis, run by Assiut University at 1 site in Egypt.
Trial summary
In relapsing remitting multiple sclerosis (RRMS) the relationship between cognitive impairment (CI), fatigue and physical disability with white matter lesion load (WM-LL), location among other volumetric measures using automated platforms is still unclear. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Relapsing Remitting Multiple Sclerosis
- What is being tested?
- VolBrain, a fully automated platform to generate the volumetric data (lesion count, volume and location as well as different atrophy measures) and Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS)
- How many people
- 63 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2022to 30 Sep 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with relapsing remitting multiple sclerosis
Who may be able to join
- : adult patients of both sexes diagnosed with RRMS according to 2017 McDonald diagnostic criteria
Who cannot join
- Patients with relapse or steroid administration in the past 30 days were excluded. Patients who have any medical conditions that may affect cognition, and those on psychoactive pharmacotherapy were also excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: White Matter Lesion Load and Location in Relation to Cognition, Fatigue and Physical Disability in Patients With Relapsing Remitting Multiple Sclerosis
In relapsing remitting multiple sclerosis (RRMS) the relationship between cognitive impairment (CI), fatigue and physical disability with white matter lesion load (WM-LL), location among other volumetric measures using automated platforms is still unclear.
Read the detailed description
Cognitive impairment (CI) and fatigue have been recognized as an important feature of MS, affecting up to 70% patients (1), evident since onset and increase in both prevalence and severity as the disease progresses (2). In fact, their effects on patients and even their caregivers are more pronounced than clinical disability, causing unemployment, treatment non-adherence, personality changes as well as several psychosocial dysfunctions (3-5). Therefore, beside evaluating the physical disability, it is essential for health professionals to objectively evaluate either the cognitive function or fatigue at both baseline and during routine follow up visits for early detection and management (6). Through the advances in MRI techniques and availability of a number of automated software, quantitative radiological assessments became more readily available and feasible in daily practice (7) allowing objective longitudinal monitoring of patients (8,9). Although burden and location of lesions in RRMS is thought to be associated with cognitive impairment (CI), fatigue and physical disability, some controversy results were obtained from previous studies. So, by conducting this study, we aimed at exploring the relationship between different parameters of lesion load and location with fatigue, cognitive and physical disability in RRMS patients.
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Being tested
- VolBrain, a fully automated platform to generate the volumetric data (lesion count, volume and location as well as different atrophy measures), Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS)
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VolBrain, a fully automated platform to generate the volumetric data (lesion count, volume and location as well as different atrophy measures)Diagnostic test
VolBrain, a fully automated platform that uses anonymized compressed NIFTI files to generate the volumetric data. Volbrain is increasingly recognized and compared to other volumetric tools. LesionBrain is a pipeline to automatically segment WM-L from T1 and FLAIR data. Number of lesions, absolute total lesion volume (in cubic cm), normalized lesion volume (percentage of total lesion volume to whole brain volume), lesion burden (percentage of total WM lesion volume to WM volume), and location (Periventricular, Juxtacortical, and Infratentorial) were obtained.
Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS)Other
It includes the Symbol Digit Modalities Test (SDMT) for evaluating the information processing speed, the California Verbal Learning Test (CVLT-II) for evaluating verbal learning and memory, and the Brief Visual Memory Test (BVMT) for evaluating visual learning and memory. Cut off values were calculated as 1.5 SD below mean according to a group of healthy individuals who are matched in age, sex and education as following: 22 for SDMT, 38 for CVLT, and 10 for BVMTR
What is being measured
The primary outcome is the main question the study is designed to answer.
The relation of white matter lesion load, location and parameters of cognitive function measured by BICAMS
correlation of BICAMS subtests scores to different parameters of white matter lesion load, distribution and load (volume and number of lesion) measurements (whole brain atrophy, grey matter and white matter lesion load) to identify best predictors of cognitive impairment
Measured: 6 months
The relation of white matter lesion load, location and Fatigue in patients with relapsing remitting multiple sclerosis
correlation between fatigue severity, with white matter lesion load, and distribution in order to identify predictors of fatigue
Measured: 6 months
Secondary outcomes (1)
the relation of white matter lesion load, location and atrophy parameters to physical disability in patients with relapsing remitting multiple sclerosis
correlation of EDSS scores, with white matter lesion load and distribution
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2022
- Study start1 Mar 2022
- Primary completion31 Aug 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing Remitting Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman M. Khedr, Assiut University
- Investigators
- Eman M Khedr, professor, Principal investigator, Assuit university hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05604092
- Sponsor's protocol ID
- lesion load and distribution
- Status last verified
- Oct 2022
- First submitted
- 21 Oct 2022
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- White Matter Lesion Load and Location in Relation to Cognition, Fatigue and Physical Disability in Patients With Relapsing Remitting Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05604092
- Acronym / sponsor ID
- lesion load and distribution
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 3 Nov 2022 (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.
In relapsing remitting multiple sclerosis (RRMS) the relationship between cognitive impairment (CI), fatigue and physical disability with white matter lesion load (WM-LL), location among other volumetric measures using automated platforms is still unclear.
Detailed description
Cognitive impairment (CI) and fatigue have been recognized as an important feature of MS, affecting up to 70% patients (1), evident since onset and increase in both prevalence and severity as the disease progresses (2). In fact, their effects on patients and even their caregivers are more pronounced than clinical disability, causing unemployment, treatment non-adherence, personality changes as well as several psychosocial dysfunctions (3-5). Therefore, beside evaluating the physical disability, it is essential for health professionals to objectively evaluate either the cognitive function or fatigue at both baseline and during routine follow up visits for early detection and management (6). Through the advances in MRI techniques and availability of a number of automated software, quantitative radiological assessments became more readily available and feasible in daily practice (7) allowing objective longitudinal monitoring of patients (8,9). Although burden and location of lesions in RRMS is thought to be associated with cognitive impairment (CI), fatigue and physical disability, some controversy results were obtained from previous studies. So, by conducting this study, we aimed at exploring the relationship between different parameters of lesion load and location with fatigue, cognitive and physical disability in RRMS patients.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with relapsing remitting multiple sclerosis
Key inclusion criteria (1 listed)
- : adult patients of both sexes diagnosed with RRMS according to 2017 McDonald diagnostic criteria
Key exclusion criteria (1 listed)
- Patients with relapse or steroid administration in the past 30 days were excluded. Patients who have any medical conditions that may affect cognition, and those on psychoactive pharmacotherapy were also excluded.
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 |
|---|---|---|
| VolBrain, a fully automated platform to generate the volumetric data (lesion count, volume and location as well as different atrophy measures)VolBrain, a fully automated platform that uses anonymized compressed NIFTI files to generate the volumetric data. Volbrain is increasingly recognized and compared to other volumetric tools. LesionBrain is a pipeline to automatically segment WM-L from T1 and FLAIR data. Number of lesions, absolute total lesion volume (in cubic cm), normalized lesion volume (percentage of total lesion volume to whole brain volume), lesion burden (percentage of total WM lesion volume to WM volume), and location (Periventricular, Juxtacortical, and Infratentorial) were obtained. | Diagnostic test | – |
| Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS)It includes the Symbol Digit Modalities Test (SDMT) for evaluating the information processing speed, the California Verbal Learning Test (CVLT-II) for evaluating verbal learning and memory, and the Brief Visual Memory Test (BVMT) for evaluating visual learning and memory. Cut off values were calculated as 1.5 SD below mean according to a group of healthy individuals who are matched in age, sex and education as following: 22 for SDMT, 38 for CVLT, and 10 for BVMTR | Other | – |
Primary outcome
The relation of white matter lesion load, location and parameters of cognitive function measured by BICAMS
Time frame: 6 months
correlation of BICAMS subtests scores to different parameters of white matter lesion load, distribution and load (volume and number of lesion) measurements (whole brain atrophy, grey matter and white matter lesion load) to identify best predictors of cognitive impairment
The relation of white matter lesion load, location and Fatigue in patients with relapsing remitting multiple sclerosis
Time frame: 6 months
correlation between fatigue severity, with white matter lesion load, and distribution in order to identify predictors of fatigue
1 secondary outcome
the relation of white matter lesion load, location and atrophy parameters to physical disability in patients with relapsing remitting multiple sclerosis
Time frame: 6 months
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 3 Nov 2022.
- Individual participant dataSharing planned: No
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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.
Eman M Khedr, professor principal investigator
Assuit university hospital
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 Relapsing Remitting Multiple Sclerosis, run by Assiut University at 1 site in Egypt.
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 3 Nov 2022. 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 Egypt. 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?
The relation of white matter lesion load, location and parameters of cognitive function measured by BICAMS (time frame: 6 months). The study lists 2 primary outcomes in all. 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 3 Nov 2022.