Status:
RECRUITING
Cognitive Rehabilitation of Deficits in Patients With Multiple Sclerosis
Lead Sponsor:
Universita di Verona
Conditions:
Telerehabilitation
Multiple Sclerosis
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Non-Inferiority Study, Post-Market Clinical Investigation with a Device, Single-Blind Randomized Controlled Trial in a Cohort of Patients Diagnosed with Multiple Sclerosis (MS). The aim of the study ...
Eligibility Criteria
Inclusion
- Diagnosis of relapsing-remitting multiple sclerosis (RRMS), or primary progressive (PPMS) or secondary progressive (SPMS), defined by at least 3-6 months.
- Age between 18 and 65 years.
- Expanded Disability Status Scale (EDSS) between 3 and 5 to include patients with overall neurological disability from mild to moderate.
- Presence of one or more of the following cognitive disorders (reported by the patient and subsequently confirmed through the Oxford Cognitive Screen-OCS):
- Memory disorders
- Attention disorders
- Executive function disorders
- Availability of internet at the patient's home necessary for the tele-rehabilitation procedures.
- Adequate visual and auditory abilities to use the rehabilitation device.
Exclusion
- Presence of other neurological conditions;
- Psychiatric disorders in medical history;
- Alcohol and/or drug abuse;
- Presence of uncorrected severe visual deficits.
Key Trial Info
Start Date :
February 8 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06964581
Start Date
February 8 2023
End Date
September 30 2025
Last Update
May 9 2025
Active Locations (1)
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1
Azienda Ospedaliera Universitaria Integrata Verona - UOC di Neuroriabilitazione
Verona, verona, Italy, 37134