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

RecruitingNot a drug-phase studyRelapsing and progressiveNCT06964581

What it found

Still running

No result yet.

What was tested

Treatment tested

  • Cognitive treatment delivered via telerehabilitation.

Compared with

  • In-person cognitive treatment.

What it measured

Main measures

  • Paced Auditory Serial Addition Task (PASAT)

    The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen

    Thinking and memory

Other measures (10)

  • Trail Making Test Part A (TMT-A)

    The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen

    Thinking and memory
  • Trail Making Test Part B (TMT-B)

    The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen

    Thinking and memory
  • Symbol Digit Modalities Test

    The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen

    Thinking and memory
  • Modified Five Point Test (MFPT)

    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)

    The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen

    Thinking and memory
  • Phonemic Verbal Fluency Test

    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 is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen

    Thinking and memory
  • Modified Fatigue Impact Scale (MFIS)

    The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen

    Fatigue
  • Multiple Sclerosis Quality of Life 54 (MSQOL-54)

    The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen

    Quality of life (reported by participants)
  • Depression, Anxiety, and Stress Scale (DASS)

    The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen

    Mood and sleep

Who could take part

Relapsing and progressive · 18 to 65 · EDSS 3 to 5

Show the full 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.

As registered. Criteria can change, so ask the trial team or your neurologist.

Contact details on the registry

About this trial

In the sponsor's words

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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History

    1. Started

      Feb 2023

    2. Main results due

      Apr 2025

    3. Finished

      Sept 2025

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