Cognitive Rehabilitation of Deficits in Patients With Multiple Sclerosis

University of Verona

Status: Enrolling

Conditions: Telerehabilitation; Multiple Sclerosis; Neurorehabilitation; Cognitive Disorders

Treatments: Behavioral: Cognitive treatment delivered via telerehabilitation.; Behavioral: In-person cognitive treatment.

Study type: Interventional

Funder types: Other

Identifiers

NCT06964581

3995CESC

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

60 participants in 2 patient groups

Telerehabilitation

Experimental group

Description:

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.

Treatment:

Behavioral: Cognitive treatment delivered via telerehabilitation.

In-person treatment

Active Comparator group

Description:

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.

Treatment:

Behavioral: In-person cognitive treatment.