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Memory Rehabilitation Strategies in Patients With Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Cognitive Rehabilitation
Combined Rehabilitation
Motor Rehabilitation
Sponsored by
I.R.C.C.S. Fondazione Santa Lucia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Cognitive Rehabilitation, Motor Rehabilitation, Cognitive Impairment

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Cognitive Rehabilitation

Combined Training

Motor Rehabilitation

Arm Description

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

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.

the third group carried out a traditional MR training.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 4, 2022
Last Updated
July 14, 2022
Sponsor
I.R.C.C.S. Fondazione Santa Lucia
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1. Study Identification

Unique Protocol Identification Number
NCT05462678
Brief Title
Memory Rehabilitation Strategies in Patients With Multiple Sclerosis
Official Title
Strategies and Techniques for the Rehabilitation of Memory Deficits in Patients With Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
April 20, 2021 (Actual)
Study Completion Date
November 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
I.R.C.C.S. Fondazione Santa Lucia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Cognitive Rehabilitation, Motor Rehabilitation, Cognitive Impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Rehabilitation
Arm Type
Experimental
Arm Description
the first group carried out a training of CR by three memory modules of the Rehacom program (http://www.emsmedical.net).
Arm Title
Combined Training
Arm Type
Experimental
Arm Description
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.
Arm Title
Motor Rehabilitation
Arm Type
Experimental
Arm Description
the third group carried out a traditional MR training.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Rehabilitation
Intervention Description
Each patient performed two weekly sessions of 45 minutes each, for 12 weeks
Intervention Type
Behavioral
Intervention Name(s)
Combined Rehabilitation
Intervention Description
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
Intervention Name(s)
Motor Rehabilitation
Intervention Description
Each patient performed two weekly sessions45 minutes each, for a total of 12 weeks.
Primary Outcome Measure Information:
Title
Pre- and Post treatment and long term cognitive efficiency
Description
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.
Time Frame
9-months
Secondary Outcome Measure Information:
Title
Pre- and Post-treatment and long term motor efficiency
Description
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.
Time Frame
9-months
Other Pre-specified Outcome Measures:
Title
Pre- and Post-treatment and long term disability and overall quality of life
Description
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.
Time Frame
9-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ugo Nocentini, MD
Organizational Affiliation
I.R.C.C.S. "Santa Lucia" Foundation
Official's Role
Study Director
Facility Information:
Facility Name
Santa Lucia Foundation I.R.C.C.S.
City
Roma
State/Province
Rm
ZIP/Postal Code
00179
Country
Italy
Facility Name
I.R.C.C.S. "Santa Lucia" Foundation
City
Rome
ZIP/Postal Code
00149
Country
Italy

12. IPD Sharing Statement

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Memory Rehabilitation Strategies in Patients With Multiple Sclerosis

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