Cognitive Rehabilitation of Deficits in Patients With Multiple Sclerosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cognitive treatment delivered via telerehabilitation., In-person cognitive treatment..
- Who it may be relevant to
- Registry conditions: Telerehabilitation, Multiple Sclerosis, Cognitive Disorders, Neurorehabilitation. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Cognitive Rehabilitation of Deficits in Patients With Multiple Sclerosis: Proposal for an Integrated Cognitive Treatment in a Telematic Format
Overview
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.
Interventions
- 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.
Primary outcome measures
- Paced Auditory Serial Addition Task (PASAT) [Time frame: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen]
Secondary outcome measures (10)
- Trail Making Test Part A (TMT-A) [Time frame: 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) [Time frame: 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 [Time frame: 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) [Time frame: 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) [Time frame: 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 [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Italy · 1 center
- Azienda Ospedaliera Universitaria Integrata Verona - UOC di Neuroriabilitazione — Verona
Identifiers
NCT: NCT06964581 · 3995CESC