Validating a self-administered, language-independent iPad-based test for assessment and monitoring of cognitive impairment in patients with multiple sclerosis (MS)
| ISRCTN | ISRCTN17924218 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17924218 |
| Secondary identifying numbers | CGN-1702 |
- Submission date
- 12/02/2018
- Registration date
- 16/02/2018
- Last edited
- 22/06/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English summary of protocol
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)
Contact information
Scientific
Royan Institute
Banihashem Square
Tehran
19395-4644
Iran
Study information
| Study design | Single-center observational case-control study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case-control study |
| Study setting(s) | Other |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A brief language-independent and self-administered computerized tool for cognitive assessment in multiple sclerosis (MS) |
| Study objectives | 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(s) | Research Ethics Commitee of Royan Institute, 08/08/2017, ref: IR.ACECR.ROYAN.REC.IR.ACECR.ROYAN.REC.1396.98 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/12/2017 |
| Completion date | 30/07/2018 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 160 participants in total. (80 MS; 80 healthy controls ) |
| Total final enrolment | 174 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 05/01/2018 |
| Date of final enrolment | 30/04/2018 |
Locations
Countries of recruitment
- Iran
Study participating centre
Tehran
143591537
Iran
Sponsor information
Industry
3 Waterhouse Square
138 Holborn
London
EC1N 2SW
United Kingdom
| Website | http://cognetivity.com/ |
|---|
Research organisation
Banihashem Square
Tehran
148- 6635
Iran
| Website | http://www.royaninstitute.org/cmsen/ |
|---|
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 30/09/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| 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 plan | The current data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2020 | 22/06/2020 | Yes | No |
Editorial Notes
22/06/2020: Pre-print link replaced with publication link.
13/05/2020: The following changes have been made:
1. Preprint reference added.
2. The final enrolment number has been added from the reference.
26/03/2019: Internal review.
