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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telerehabilitation | Experimental | 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 treatment | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive treatment delivered via telerehabilitation. | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Valentina Varalta, Doctor | Contact | 045 8124956 | valentina.varalta@univr.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliera Universitaria Integrata Verona - UOC di Neuroriabilitazione | Recruiting | Verona | verona | 37134 | Italy |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| In-person cognitive treatment. | Behavioral | 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. |
|
| The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen |
| 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. | The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen |
| 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). | The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen |
| 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). | The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen |
| "Learning" subtest of the Rivermead Behavioural Memory Test-3 (RBMT-3) | "Learning" subtest of the Rivermead Behavioural Memory Test-3 (RBMT-3), used to assess the ability to learn and recall visuospatial information after a delay. The learning trial has a score range of 0 to 51 correct items, and the delayed recall trial ranges from 0 to 17 correct items, with higher scores indicating better performance. | The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen |
| Phonemic Verbal Fluency Test | The Phonemic Verbal Fluency Test is used to investigate the ability to access the semantic-lexical store (number of items, with higher scores indicating better performance). | The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen |
| Test of Attentional Performance (TAP) | The Test of Attentional Performance (TAP) is used to assess reaction times ("Alertness") and the ability to inhibit automatic responses ("Go/No-Go") (reaction times, with higher scores indicating worse performance). | The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen |
| Modified Fatigue Impact Scale (MFIS) | The Modified Fatigue Impact Scale (MFIS) is used to evaluate the degree of fatigue (range 0-84, with higher scores indicating worse performance). | The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen |
| Multiple Sclerosis Quality of Life 54 (MSQOL-54) | The Multiple Sclerosis Quality of Life 54 (MSQOL-54) is used to assess quality of life (range varies by item, with higher scores indicating better performance). | The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen |
| Depression, Anxiety, and Stress Scale (DASS) | The Depression, Anxiety, and Stress Scale (DASS) is used to evaluate psychological well-being (range 0-63, with higher scores indicating worse performance). | The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |