Cognitive Rehabilitation of Deficits in Patients With Multiple Sclerosis

April 30, 2025 updated by: Valentina Varalta, Universita di Verona

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Verona, Italy, 37134
        • Recruiting
        • Azienda Ospedaliera Universitaria Integrata Verona - UOC di Neuroriabilitazione
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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: 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.
Active Comparator: In-person 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
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
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
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
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)
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
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)
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), 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
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
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)
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
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)
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
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)
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
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)
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universita di Verona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 8, 2023

Primary Completion (Actual)

April 22, 2025

Study Completion (Estimated)

September 30, 2025

Study Registration Dates

First Submitted

April 30, 2025

First Submitted That Met QC Criteria

April 30, 2025

First Posted (Actual)

May 9, 2025

Study Record Updates

Last Update Posted (Actual)

May 9, 2025

Last Update Submitted That Met QC Criteria

April 30, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3995CESC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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