RECRUITINGINTERVENTIONAL

Cognitive Rehabilitation of Deficits in Patients With Multiple Sclerosis

Cognitive Rehabilitation of Deficits in Patients With Multiple Sclerosis: Proposal for an Integrated Cognitive Treatment in a Telematic Format

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - Presence of other neurological conditions; - Psychiatric disorders in medical history; - Alcohol and/or drug abuse; - Presence of uncorrected severe visual deficits. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

BEHAVIORAL

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.

BEHAVIORAL

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.

Locations (1)

Azienda Ospedaliera Universitaria Integrata Verona - UOC di Neuroriabilitazione

Verona, verona, Italy