Cognitive Rehabilitation of Deficits in Patients With Multiple Sclerosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversita di Verona
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Memory disorders
Disqualifiers
Presence of other neurological conditions;
Psychiatric disorders in medical history;
Alcohol and/or drug abuse;
Presence of uncorrected severe visual deficits.
Trial design
Design model
Parallel
Treatments tested in this trial
Cognitive treatment delivered via telerehabilitation.
BehavioralThree 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.
BehavioralThree 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: TelerehabilitationExperimental treatment 1 intervention
Group B: In-person treatmentActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Paced Auditory Serial Addition Task (PASAT)
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.
Time frame
The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmenSecondary outcomes
1
Trail Making Test Part A (TMT-A)
The Trail Making Test Part A (TMT-A) is a neuropsychological assessment that measures selective attention and processing speed. Participants connect a series of numbered circles in sequential order as quickly as possible. The score is determined by the time taken to complete the task, with shorter times indicating better performance. Errors may negatively impact the score.
Time frame
The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen2
Trail Making Test Part B (TMT-B)
The Trail Making Test Part B (TMT-B) is a neuropsychological test that measures Divided attention. Participants must connect numbered and lettered circles in alternating order as quickly as possible. The score is based on the time taken to complete the test, with shorter times indicating better performance. Any errors may negatively impact the score.
Time frame
The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen3
Symbol Digit Modalities Test
This test evaluates the visual information processing speed and attention; the number of correct answers in 90 seconds is registered (higher scores indicate better performance).
Time frame
The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen4
Modified Five Point Test (MFPT)
The Modified Five Point Test (MFPT), which is a measure of figural fluency assessing the ability to initiate mental productivity and self-monitoring during a visual-spatial task. Performance is assessed by scoring the total number of correct and unique designs generated in 3 min (UDs), and the total number of UDs produced into strategies (CSs).
Time frame
The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmenSponsors and contacts
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Source ClinicalTrials.gov