Plain English Summary
Background and study aims
Multiple sclerosis (MS) is a condition that affects the brain and spinal cord. Cognitive impairment is common in patients with MS however it is not routinely assessed in the clinic setting. Cognitive impairment causes a decline in memory and thinking skills. The currently available reference tests for assessing cognitive impairment in MS are typically long and need an expert to administer the test. Researches have developed a 5-minute iPad based test that is self-administered and language independent to measure cognitive dysfunction in patients with MS. This test is called an Integrated Cognitive Assessment tool (or ICA). The aim of this study is to validate an iPad-based test in assessing cognitive dysfunction in patients with MS to show that the test outcome has construct validity with BICAMS (Brief International Cognitive Assessment for MS).
Who can participate?
MS patients and healthy controls that are within the same age-range.
What does the study involve?
All participants are randomly allocated to the order in which they undergo two difference types of cognitive assessment. Participants take the recently developed integrated cognitive assessment (ICA) test on an iPad that takes about five minutes. Each participant also takes the BICAMS test that lasts about 20 minutes. BICAMS is a battery of three pen and paper test. This includes the Symbol Digit Modalities Test (SDMT) which measures cognitive processing speed, the California Verbal Learning Test and the Brief Visuospatial Memory Test. In the follow-up session, each participant takes the SDMT test, and the ICA iPad test.
What are the possible benefits and risks of participating?
Participants will benefit from a comprehensive cognitive assessment, and a follow-up after about four month. There are no risks associated with participating in the study, particularly because the study only contains behavioral cognitive assessments (i.e. pen and paper tests, and a computerized test).
Where is the study run from?
MS specialist clinic, Aria Medical Complex (Iran)
When is the study starting and how long is it expected to run for?
December 2017 to July 2018
Who is funding the study?
Cognetivity Ltd (UK)
Who is the main contact?
Dr Seyed-Mahdi Khaligh-Razavi (Scientific)
A brief language-independent and self-administered computerized tool for cognitive assessment in multiple sclerosis (MS)
The aim of this study is to validate an iPad-based test in assessing cognitive dysfunction in patients with MS. We will show that the test outcome has construct validity with BICAMS (Brief International Cognitive Assessment for MS).
Research Ethics Commitee of Royan institute, 08/08/2017, ref: IR.ACECR.ROYAN.REC.IR.ACECR.ROYAN.REC.1396.98
Single-center observational case-control study
Primary study design
Secondary study design
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
After enrollment in the study, both MS and healthy participants go through two types of cognitive assessment in a randomized order. Participants take the recently developed integrated cognitive assessment (ICA) test on an iPad that takes about five minutes. Each participant also take the BICAMS test that lasts about 20 minutes. BICAMS is a battery of three pen and paper tests:
1. Symbol Digit Modalities Test (SDMT) which is a measure of cognitive processing speed and takes about 5 minute
2. The initial learning trials of the California Verbal Learning Test 2nd Edition (CVLT-II), which takes 10 minutes to complete
3. The Brief Visuospatial Memory Test-Revised (BVMT-R), which takes 5 minutes
In the follow-up session, each participant takes the SDMT test (~5 min duration), and the ICA iPad test (~5min) in a randomized order.
Primary outcome measures
1. Cognitive dysfunction is measured using the BICAMS score at baseline, and four months
2. Cognitive dysfunction is measured using the Integrated Congitive Assessmnet (ICA) score at baseline and four months
Secondary outcome measures
1. Reliability for SDMT is measured by correlating SDMT categorizations (i.e. cognitively intact, mildly impaired, severely impaired) made on the first visit and the second visit
2. Reliability for ICA is measured by correlating ICA categorizations (i.e. cognitively intact, mildly impaired, severely impaired) made on the first visit and the second visit
Overall trial start date
Overall trial end date
Participant inclusion criteria
1. Definite diagnosis of MS in all the following categories, regardless of age, sex and education level:
1.1. RR: relapsing remitting
1.2. PP: primary progressive
1.3. SP: secondary progressive
2. Healthy controls within an age-range similar to the MS patients
Target number of participants
160 participants in total. (80 MS; 80 healthy controls )
Participant exclusion criteria
1. Moderate to Severe Depression as measured by Beck’s Score
2. Interfering motor problems (e.g. upper limb motor dysfunction)
3. Vision problems that cannot be corrected with eye-glasses such that it prevents participant from reading
4. Presence of other neurological disorders medical illnesses that affect brain function and cognition
5. History of seizures
6. History of drug or alcohol abuse
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
MS Specialist Clinic Aria Medical Complex
No. 218, Mollasadra St
3 Waterhouse Square
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Planned publication in Multiple Sclerosis Journal ( MSJ) or other similarly prestigious peer-reviewed journals. No such additional documents are currently available for publication/pre-print.
IPD sharing statement:
The current data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
Participant level data
To be made available at a later date
Results - basic reporting