Memory Rehabilitation Strategies in Patients With Multiple Sclerosis

Strategies and Techniques for the Rehabilitation of Memory Deficits in Patients With Multiple Sclerosis

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).

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Behavioral: Cognitive Rehabilitation; Behavioral: Combined Rehabilitation; Behavioral: Motor Rehabilitation

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy, 00149
    • I.R.C.C.S. "Santa Lucia" Foundation
  • Rm
    • Roma, Rm, Italy, 00179
      • Santa Lucia Foundation I.R.C.C.S.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive Rehabilitation; the first group carried out a training of CR by three memory modules of the Rehacom program (http://www.emsmedical.net).	Behavioral: Cognitive Rehabilitation; Each patient performed two weekly sessions of 45 minutes each, for 12 weeks
Experimental: 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.	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.
Experimental: Motor Rehabilitation; the third group carried out a traditional MR training.	Behavioral: Motor Rehabilitation; Each patient performed two weekly sessions45 minutes each, for a total of 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pre- and Post treatment and long term cognitive efficiency	The primary outcome of this study is the scores on the cognitive tasks (Minimal Assessment of Cognitive Functioning in Multiple Sclerosis -MACFIMS). For MACFIMS score ranges from 1 to 3 with higher scores corresponding to higher cognitive impairment.	9-months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pre- and Post-treatment and long term motor efficiency	The secondary outcome of this study is the scores on the gait and balance efficiency scales (Tinetti Scale -TS); For TS the score ranges from 0 to 28 with higher scores corresponding to higher efficiency.	9-months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pre- and Post-treatment and long term disability and overall quality of life	Tertiary outcome is the scores on the self-perceived quality of life assessed with World Health Organization Disability Assessment Schedule- WHO-DAS 2. For WHO-DAS 2 total score ranges from 0 to 100, with lower scores indicate lower levels of disability e better quality of life.	9-months

Collaborators and Investigators

• Sponsor: I.R.C.C.S. Fondazione Santa Lucia
• Investigators: Study Director: Ugo Nocentini, MD, I.R.C.C.S. "Santa Lucia" Foundation

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Actual): April 20, 2021
• Study Completion (Actual): November 20, 2021

Study Registration Dates

• First Submitted: July 4, 2022
• First Submitted That Met QC Criteria: July 14, 2022
• First Posted (Actual): July 18, 2022

Study Record Updates

• Last Update Posted (Actual): July 18, 2022
• Last Update Submitted That Met QC Criteria: July 14, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Cognitive Impairment; Cognitive Rehabilitation; Motor Rehabilitation
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: CE/PROG.698

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No