Clinical trial NCT06964581: Cognitive Rehabilitation of Deficits in Patients With Multiple Sclerosis
Official title: Cognitive Rehabilitation of Deficits in Patients With Multiple Sclerosis: Proposal for an Integrated Cognitive Treatment in a Telematic Format
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Telerehabilitation
Multiple Sclerosis
Cognitive Disorders
Neurorehabilitation
Keywords: telerehabilitation
multiple sclerosis
cognitive disorders
Lead sponsor: Universita di Verona
Sponsor class: OTHER
First posted: 2025-05-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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 criteria: 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 outcomes:
measure: Paced Auditory Serial Addition Task (PASAT)
timeFrame: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen
Secondary outcomes:
measure: Trail Making Test Part A (TMT-A)
timeFrame: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen
measure: Trail Making Test Part B (TMT-B)
timeFrame: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen
measure: Symbol Digit Modalities Test
timeFrame: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen
measure: Modified Five Point Test (MFPT)
timeFrame: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen
measure: "Learning" subtest of the Rivermead Behavioural Memory Test-3 (RBMT-3)
timeFrame: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen
measure: Phonemic Verbal Fluency Test
timeFrame: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen
measure: Test of Attentional Performance (TAP)
timeFrame: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen
measure: Modified Fatigue Impact Scale (MFIS)
timeFrame: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen
measure: Multiple Sclerosis Quality of Life 54 (MSQOL-54)
timeFrame: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen
measure: Depression, Anxiety, and Stress Scale (DASS)
timeFrame: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen
Other outcomes:
Locations:
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata Verona - UOC di Neuroriabilitazione
Study officials:
References: