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Validating a self-administered, language-independent iPad-based test for assessment and monitoring of cognitive impairment in patients with multiple sclerosis (MS)

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN17924218
Enrollment
160
Registered
2018-02-16
Start date
2018-01-05
Completion date
Unknown
Last updated
2020-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple sclerosis Nervous System Diseases Multiple sclerosis

Interventions

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 assess

Sponsors

Cognetivity Ltd
Lead Sponsor
Royan Institute
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Iran

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026