Memory Rehabilitation Strategies in Patients With Multiple Sclerosis

NCT ID: NCT05462678

Last Updated: 2022-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2021-11-20

Brief Summary

The clinical characteristics of MS are extremely variable from one patient to another. In about 60% of cases, motor disabilities are associated with cognitive deficits. The present study aims to compare three forms of cognitive / motor rehabilitation in three groups of patients with MS: rehabilitation of verbal memory with the Rehacom program; combined rehabilitation, associating a motor rehabilitation path with the Rehacom program; only motor rehabilitation course. Aims of the study will be: to verify whether the combined cognitive / motor rehabilitation can induce a significantly greater improvement in the memory performance of patients with MS compared to rehabilitation alone; check whether any improvement is objectively verifiable by patients and the impact it may have on patients' quality of life; monitor these effects after 6 months.

For these purposes, three homogeneous groups of 20 patients each will be enrolled, diagnosed with MS according to Mc Donald's criteria revisited by Polman (2011). The study will be divided into an initial clinical, cognitive, emotional, quality of life and functional self-perception (T0) assessment. Subsequently, the patients assigned to the three conditions will be provided with the pre-established rehabilitation treatments for a total duration of 12 weeks; at the end, each patient will undergo an overall re-evaluation (T1). Finally, a further overall reassessment will be carried out after 6 months, aimed at follow-up monitoring (T2).

Statistical analyzes will be of two types:

Within Group (aimed at assessing any improvement in the cognitive performance of each group of patients by comparing the assessments at T0 with those at T1 and T2); Between Group (aimed at comparing the results obtained by each group with those of the other 2 groups at T0, T1, and T2).

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Motor Rehabilitation

the third group carried out a traditional MR training.

Group Type: EXPERIMENTAL

Motor Rehabilitation

Intervention Type: BEHAVIORAL

Each patient performed two weekly sessions45 minutes each, for a total of 12 weeks.

Cognitive Rehabilitation

the first group carried out a training of CR by three memory modules of the Rehacom program (http://www.emsmedical.net).

Group Type: EXPERIMENTAL

Cognitive Rehabilitation

Intervention Type: BEHAVIORAL

Each patient performed two weekly sessions of 45 minutes each, for 12 weeks

Combined Training

the second group followed a mixed training program with the use of the version of the verbal memory module of the Rehacom program combined with the MR training.

Group Type: EXPERIMENTAL

Combined Rehabilitation

Intervention Type: BEHAVIORAL

Each patient performed one session per week (45 minutes) of CR and one session per week of traditional MR training for 12 weeks.

Interventions

Cognitive Rehabilitation

Each patient performed two weekly sessions of 45 minutes each, for 12 weeks

Intervention Type: BEHAVIORAL

Combined Rehabilitation

Each patient performed one session per week (45 minutes) of CR and one session per week of traditional MR training for 12 weeks.

Intervention Type: BEHAVIORAL

Motor Rehabilitation

Each patient performed two weekly sessions45 minutes each, for a total of 12 weeks.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Diagnosis of MS defined according to McDonald's diagnostic criteria revised in 2011.
• RRMS or SPMS phenotype.
• Language Italian mother tongue.
• EDSS score <6.0

Exclusion Criteria

• Neurological or psychiatric pathologies other than MS that can interfere with cognitive functioning
• Clinical relapses in the three months prior to enrollment
• Severe mental illness
• Psychiatric disorders severe enough to interfere with cognitive functioning
• Medications Steroid therapy in the 3 months prior to enrollment
• Motor limitations Upper limb dysfunction (paralysis or tremor) that does not allow to hold the PC mouse
• Sensory limitations Visual acuity impaired enough to not allow reading of the instructions to the various tests

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

I.R.C.C.S. Fondazione Santa Lucia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ugo Nocentini, MD

Role: STUDY_DIRECTOR

I.R.C.C.S. "Santa Lucia" Foundation

Locations

Santa Lucia Foundation I.R.C.C.S.

Roma, Rm, Italy

I.R.C.C.S. "Santa Lucia" Foundation

Rome, , Italy

Countries

Italy

References

Argento O, Piacentini C, Bossa M, Caltagirone C, Santamato A, Saraceni V, Nocentini U. Motor, cognitive, and combined rehabilitation approaches on MS patients' cognitive impairment. Neurol Sci. 2023 Mar;44(3):1109-1118. doi: 10.1007/s10072-022-06552-4. Epub 2022 Dec 21.

Reference Type: DERIVED

PMID: 36542204 (View on PubMed)

Other Identifiers

CE/PROG.698

Identifier Type: -

Identifier Source: org_study_id