Идёт набор NCT06964581

Cognitive Rehabilitation of Deficits in Patients With Multiple Sclerosis

Без фазы С лечением Telerehabilitation Multiple Sclerosis Cognitive Disorders Neurorehabilitation

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Cognitive treatment delivered via telerehabilitation., In-person cognitive treatment..
Кому может быть актуально: Состояния в реестре: Telerehabilitation, Multiple Sclerosis, Cognitive Disorders, Neurorehabilitation. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Италия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Вмешательства

Поведенческое 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.
Поведенческое 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.

Первичные конечные точки

Paced Auditory Serial Addition Task (PASAT) [Срок оценки: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen]

Вторичные конечные точки (10)

Trail Making Test Part A (TMT-A) [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen]

Критерии участия

Критерии включения

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.