Condition category
Nervous System Diseases
Date applied
12/02/2018
Date assigned
16/02/2018
Last edited
15/02/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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)

Trial website

Contact information

Type

Scientific

Primary contact

Dr Seyed-Mahdi Khaligh-Razavi

ORCID ID

Contact details

Royan Institute
Banihashem Square
Tehran
19395-4644
Iran

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CGN-1702

Study information

Scientific title

A brief language-independent and self-administered computerized tool for cognitive assessment in multiple sclerosis (MS)

Acronym

Study hypothesis

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).

Ethics approval

Research Ethics Commitee of Royan institute, 08/08/2017, ref: IR.ACECR.ROYAN.REC.IR.ACECR.ROYAN.REC.1396.98

Study design

Single-center observational case-control study

Primary study design

Observational

Secondary study design

Case-control study

Trial setting

Other

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Multiple sclerosis

Intervention

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.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

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

01/12/2017

Overall trial end date

30/07/2018

Reason abandoned (if study stopped)

Eligibility

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

Participant type

Mixed

Age group

Adult

Gender

Both

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

05/01/2018

Recruitment end date

30/04/2018

Locations

Countries of recruitment

Iran

Trial participating centre

MS Specialist Clinic Aria Medical Complex
No. 218, Mollasadra St
Tehran
143591537
Iran

Sponsor information

Organisation

Cognetivity Ltd

Sponsor details

3 Waterhouse Square
138 Holborn
London
EC1N 2SW
United Kingdom

Sponsor type

Industry

Website

http://cognetivity.com/

Organisation

Royan Institute

Sponsor details

Banihashem Square
Tehran
148- 6635
Iran

Sponsor type

Research organisation

Website

http://www.royaninstitute.org/cmsen/

Funders

Funder type

Industry

Funder name

Cognetivity Ltd

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

30/09/2018

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes