Memory Rehabilitation Strategies in Patients With Multiple Sclerosis
Strategies and Techniques for the Rehabilitation of Memory Deficits in Patients With Multiple Sclerosis
1 other identifier
interventional
60
1 country
2
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable multiple-sclerosis
Started Sep 2018
Longer than P75 for not_applicable multiple-sclerosis
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 20, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 20, 2021
CompletedFirst Submitted
Initial submission to the registry
July 4, 2022
CompletedFirst Posted
Study publicly available on registry
July 18, 2022
CompletedJuly 18, 2022
July 1, 2022
2.6 years
July 4, 2022
July 14, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Pre- and Post-treatment and long term motor efficiency
9-months
Other Outcomes (1)
Pre- and Post-treatment and long term disability and overall quality of life
9-months
Study Arms (3)
Cognitive Rehabilitation
EXPERIMENTALthe first group carried out a training of CR by three memory modules of the Rehacom program (http://www.emsmedical.net).
Combined Training
EXPERIMENTALthe 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.
Motor Rehabilitation
EXPERIMENTALthe third group carried out a traditional MR training.
Interventions
Each patient performed two weekly sessions of 45 minutes each, for 12 weeks
Each patient performed one session per week (45 minutes) of CR and one session per week of traditional MR training for 12 weeks.
Each patient performed two weekly sessions45 minutes each, for a total of 12 weeks.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Santa Lucia Foundation I.R.C.C.S.
Roma, Rm, 00179, Italy
I.R.C.C.S. "Santa Lucia" Foundation
Rome, 00149, Italy
Related Publications (1)
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.
PMID: 36542204DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ugo Nocentini, MD
I.R.C.C.S. "Santa Lucia" Foundation
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 4, 2022
First Posted
July 18, 2022
Study Start
September 1, 2018
Primary Completion
April 20, 2021
Study Completion
November 20, 2021
Last Updated
July 18, 2022
Record last verified: 2022-07