Cognitive treatment delivered via telerehabilitation.In-person cognitive treatment.
Cognitive treatment delivered via telerehabilitation.: Three hours of cognitive rehabilitation per week, carried out independently and remotely using a computerized device, which is pre-programmed according to the patient's specific needs.
In-person cognitive treatment.: Three hours of in-person cognitive rehabilitation per week using a computerized device. The participant will perform cognitive exercises on the computerized device in the presence of the therapist, who will activate the device (using credentials specifically created for them) and select the appropriate activity to administer at each session.
Study 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 is to assess whether a computer-based cognitive treatment delivered via telerehabilitation produces effects from T0 to T1 that are not inferior to those of an in-person treatment on sustained attention in a cohort of patients with MS.
The secondary objective is to evaluate the effects of telerehabilitation compared to the same treatment delivered in person on attentional shifting, memory, executive functions, and daily functioning (including cognitive fatigue, quality of life, and mood) in patients with MS.
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria:
* 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 Criteria:
* Presence of other neurological conditions;
* Psychiatric disorders in medical history;
* Alcohol and/or drug abuse;
* Presence of uncorrected severe visual deficits.
Primary outcome measure(s)
Paced Auditory Serial Addition Task (PASAT) — The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen In the Paced Auditory Serial Addition Task (PASAT), the patient listens to a recorded voice reading a series of numbers at regular intervals. They must mentally add each number to the one immediately preceding it and respond orally. The test assesses sustained attention, working memory, and processing speed. The maximum score, usually 60, corresponds to the number of correct responses, with higher scores indicating better cognitive performance.
Trial sites (1)
Facility
City
Region
Status
Azienda Ospedaliera Universitaria Integrata Verona - UOC di Neuroriabilitazione
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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