Cognitive Rehabilitation of Deficits in Patients With Multiple Sclerosis

NCT06964581 | Recruiting DMC

• 1 other identifier: 3995CESC
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Telerehabilitation; Multiple Sclerosis; Cognitive Disorders; Neurorehabilitation

Keywords

telerehabilitation; multiple sclerosis; cognitive disorders

Outcome Measures

Primary Outcomes (1)

• Paced Auditory Serial Addition Task (PASAT)

  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 Outcomes (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

• 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

• 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

• 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

Study Arms (2)

Telerehabilitation

EXPERIMENTAL

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.

In-person treatment

ACTIVE COMPARATOR

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.

Interventions

Cognitive treatment delivered via telerehabilitation. 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.

Telerehabilitation

In-person cognitive treatment. 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.

In-person treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Presence of other neurological conditions;
• Psychiatric disorders in medical history;
• Alcohol and/or drug abuse;
• Presence of uncorrected severe visual deficits.

Sponsors & Collaborators

• Universita di Verona: lead

Study Sites (1)

Azienda Ospedaliera Universitaria Integrata Verona - UOC di Neuroriabilitazione

Verona, verona, 37134, Italy

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Valentina Varalta, Doctor

CONTACT

045 8124956; valentina.varalta@univr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: May 9, 2025
• Study Start: February 8, 2023
• Primary Completion: April 22, 2025
• Study Completion: September 30, 2025
• Last Updated: May 9, 2025

Record last verified: 2025-04

Locations

IT (1)