Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06629155
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-01
Brief Title:
Studying Eye Movement Deficits and Cognitive Impairment in Patients with Multiple Sclerosis Using Infrared Eye Tracking and Cognitive Tests
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Disentangling Cognitive Functioning and Visual Scanning Deficits in Cognitive Test Results in Multiple Sclerosis MS
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VisuMS
Brief Summary:
The goal of this observational study is to study the relationship between cognitive problems and problems in eye movements in Multiple Sclerosis MS
The main questions it aims to answer are
What is the correlation between INO and cognition
How often does internuclear ophthalmoplegia INO occur in MS patients
Participants will perform specific cognitive tests and eye movements will be measured through infrared oculography
The primary hypothesis for the study is participants with INO will perform worse on cognitive tests compared to those without INO
The main questions it aims to answer are
What is the correlation between INO and cognition
How often does internuclear ophthalmoplegia INO occur in MS patients
Participants will perform specific cognitive tests and eye movements will be measured through infrared oculography
The primary hypothesis for the study is participants with INO will perform worse on cognitive tests compared to those without INO
Detailed Description:
As previously described in the brief summary this clinical study aims to investigate the relationship between cognitive impairment and problems with eye movements in Multiple Sclerosis MS
Cognitive tests
Cognitive impairment is a common symptom in patients with MS The most affected cognitive domains are information processing speed and visual memory but also the domains of attention executive function working memory visuospatial processing and verbal memory can be affected There are different valid screening and evaluation tools for cognitive impairment CI described and used in the MS field This clinical study will use the tests of the Brief International Cognitive Assessment for MS BICAMS
Infrared oculography
Another common symptom in MS is problems with eye movements An eye condition commonly seen in these patients is internuclear ophthalmoplegia INO It is a specific conjugate horizontal gaze disorder characterized by slowed movement of the adducting eye relative to the abducting eye in horizontal saccades resulting from damage to the medial longitudinal fasciculus MLF This may lead to transient diplopia or blurring of vision particularly during horizontal gaze INO can be diagnosed by using infrared oculography a noninvasive method of quantifying eye movements Recent research indicates that eye movements can reflect certain aspects of brain function and provide insights into cognitive impairments Therefore this study aims to investigate the prevalence of INO in MS using infrared oculography compare the diagnosis of INO using infrared oculography with clinical examination by a physician and lastly explore the relationship between the presence of INO and cognitive decline
Investigational plan
The study will be a prospective observational multi-center cross-sectional cohort study
Patients will be recruited at the National MS Center Melsbroek NMSC in close collaboration with Prof Miguel Dhaeseleer Neurology Prof Daphne Kos Rehabilitation and research coordinator and Mieke Dhooge Neuropsychologist At any moment in time about 80 MS patients are in a short rehabilitation admission at the National MS Centre Melsbroek Additionally patients will be recruited from the MS department in the neurology wing of UZ Brussels The MS team at UZ Brussel comprises Prof Dr Ir Guy Nagels Head of Departement Prof Dr Miguel DHaeseleer Prof Dr Marie DHooghe Dr Stéphanie Hostenbach and Annick Van Merhaegen
When patients fulfill the inclusion criteria and give active informed consent they will be contacted by phone to schedule their visit If patients would like more information they can contact the investigator by phone
During their visit patients will undergo cognitive testing and infrared oculography The investigators will start with the cognitive assessments which include the BICAMS and the PASAT The BICAMS is a 15-minute-long neuropsychological evaluation battery 9 The PASAT typically lasts 15-20 minutes Altogether the cognitive testing will take around 40 minutes Following this the infrared oculography measurements will be done According to a study that provided a standardized and reproducible protocol for infrared oculography measurements the total experiment duration was 21 minutes excluding instructions Thus the oculography process will take roughly 30 minutes To ensure enough time for each patient and avoid rushing the total duration of the visit will be approximately 15 hours per patient
After their first visit there is no need for a follow-up Should any questions arise afterward they are welcome to reach out to us via phone or email
Patients may withdraw from the study at any time for any reason
Quality assurance plan data checks
After measurement the variables that are needed for analysis have to be imported into Matlab The analysis will be automated and checked for quality issues by researchers To pass quality control at least 50 of prosaccades at 15 degrees must be captured
Source data verification To ensure accuracy and completeness two researchers will evaluate and verify the source data Any discrepancies will be documented and managed in line with the Good Clinical Practice guidelines
Data dictionary
INO will be quantified through eye movement parameters Cognitive scores will be recorded
Clinical parameters that will be recorded
EDSS score a numeric value between 0 and 10
Age a numeric value between 18 and 65
Disease duration a numeric value years
Sex female or male
Standard Operating Procedures SOPs
Only the investigators will be responsible for data entry As previously described the analysis will be automated and checked for quality issues by researchers
All data will be collected encrypted analyzed and stored on a dedicated sharepoint using the One Drive cloud service provided by the VUB secured by password protection All files from this server will be removed 5 years after the end of publication of the research results
Sample size assessment
The investigators will use a one-tailed alpha of 005 as the hypothesis is that worse visual scanning will relate to worse cognitive scores a power of 08 02 Type II error rate and a correlation coefficient of 04 - corresponding to 16 of the variance of the SDMT being explained by eyesight - which leads to a sample size of 37 To be on the safe side and to account for possible data quality issues the investigators will recruit N 50 patients in this study
Plan for missing data
In the exceptional case that some parameters are missing for some patients those patients will be excluded from the specific analyses for which these datapoints are needed
Statistical analyses plan
The investigators will use a multilinear model and transform different independent variables into a normal distribution if needed
Cognitive tests
Cognitive impairment is a common symptom in patients with MS The most affected cognitive domains are information processing speed and visual memory but also the domains of attention executive function working memory visuospatial processing and verbal memory can be affected There are different valid screening and evaluation tools for cognitive impairment CI described and used in the MS field This clinical study will use the tests of the Brief International Cognitive Assessment for MS BICAMS
Infrared oculography
Another common symptom in MS is problems with eye movements An eye condition commonly seen in these patients is internuclear ophthalmoplegia INO It is a specific conjugate horizontal gaze disorder characterized by slowed movement of the adducting eye relative to the abducting eye in horizontal saccades resulting from damage to the medial longitudinal fasciculus MLF This may lead to transient diplopia or blurring of vision particularly during horizontal gaze INO can be diagnosed by using infrared oculography a noninvasive method of quantifying eye movements Recent research indicates that eye movements can reflect certain aspects of brain function and provide insights into cognitive impairments Therefore this study aims to investigate the prevalence of INO in MS using infrared oculography compare the diagnosis of INO using infrared oculography with clinical examination by a physician and lastly explore the relationship between the presence of INO and cognitive decline
Investigational plan
The study will be a prospective observational multi-center cross-sectional cohort study
Patients will be recruited at the National MS Center Melsbroek NMSC in close collaboration with Prof Miguel Dhaeseleer Neurology Prof Daphne Kos Rehabilitation and research coordinator and Mieke Dhooge Neuropsychologist At any moment in time about 80 MS patients are in a short rehabilitation admission at the National MS Centre Melsbroek Additionally patients will be recruited from the MS department in the neurology wing of UZ Brussels The MS team at UZ Brussel comprises Prof Dr Ir Guy Nagels Head of Departement Prof Dr Miguel DHaeseleer Prof Dr Marie DHooghe Dr Stéphanie Hostenbach and Annick Van Merhaegen
When patients fulfill the inclusion criteria and give active informed consent they will be contacted by phone to schedule their visit If patients would like more information they can contact the investigator by phone
During their visit patients will undergo cognitive testing and infrared oculography The investigators will start with the cognitive assessments which include the BICAMS and the PASAT The BICAMS is a 15-minute-long neuropsychological evaluation battery 9 The PASAT typically lasts 15-20 minutes Altogether the cognitive testing will take around 40 minutes Following this the infrared oculography measurements will be done According to a study that provided a standardized and reproducible protocol for infrared oculography measurements the total experiment duration was 21 minutes excluding instructions Thus the oculography process will take roughly 30 minutes To ensure enough time for each patient and avoid rushing the total duration of the visit will be approximately 15 hours per patient
After their first visit there is no need for a follow-up Should any questions arise afterward they are welcome to reach out to us via phone or email
Patients may withdraw from the study at any time for any reason
Quality assurance plan data checks
After measurement the variables that are needed for analysis have to be imported into Matlab The analysis will be automated and checked for quality issues by researchers To pass quality control at least 50 of prosaccades at 15 degrees must be captured
Source data verification To ensure accuracy and completeness two researchers will evaluate and verify the source data Any discrepancies will be documented and managed in line with the Good Clinical Practice guidelines
Data dictionary
INO will be quantified through eye movement parameters Cognitive scores will be recorded
Clinical parameters that will be recorded
EDSS score a numeric value between 0 and 10
Age a numeric value between 18 and 65
Disease duration a numeric value years
Sex female or male
Standard Operating Procedures SOPs
Only the investigators will be responsible for data entry As previously described the analysis will be automated and checked for quality issues by researchers
All data will be collected encrypted analyzed and stored on a dedicated sharepoint using the One Drive cloud service provided by the VUB secured by password protection All files from this server will be removed 5 years after the end of publication of the research results
Sample size assessment
The investigators will use a one-tailed alpha of 005 as the hypothesis is that worse visual scanning will relate to worse cognitive scores a power of 08 02 Type II error rate and a correlation coefficient of 04 - corresponding to 16 of the variance of the SDMT being explained by eyesight - which leads to a sample size of 37 To be on the safe side and to account for possible data quality issues the investigators will recruit N 50 patients in this study
Plan for missing data
In the exceptional case that some parameters are missing for some patients those patients will be excluded from the specific analyses for which these datapoints are needed
Statistical analyses plan
The investigators will use a multilinear model and transform different independent variables into a normal distribution if needed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None