Cognitive Rehabilitation of Deficits in Patients With Multiple Sclerosis

NCT ID: NCT06964581

Last Updated: 2025-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-08

Study Completion Date

2025-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Telerehabilitation Multiple Sclerosis Cognitive Disorders Neurorehabilitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Cognitive treatment delivered via telerehabilitation.

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

In-person cognitive treatment.

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universita di Verona

OTHER

Sponsor Role lead

Responsible Party

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Valentina Varalta

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Azienda Ospedaliera Universitaria Integrata Verona - UOC di Neuroriabilitazione

Verona, verona, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Valentina Varalta, Doctor

Role: CONTACT

045 8124956

Facility Contacts

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Valentina Varalta, Doctor

Role: primary

045 8124956

Other Identifiers

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3995CESC

Identifier Type: -

Identifier Source: org_study_id

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