Clinical trial NCT05462678: 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
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Cognitive Rehabilitation
Motor Rehabilitation
Cognitive Impairment
Lead sponsor: I.R.C.C.S. Fondazione Santa Lucia
Sponsor class: OTHER
First posted: 2022-07-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Pre- and Post treatment and long term cognitive efficiency
timeFrame: 9-months
Secondary outcomes:
measure: Pre- and Post-treatment and long term motor efficiency
timeFrame: 9-months
Other outcomes:
measure: Pre- and Post-treatment and long term disability and overall quality of life
timeFrame: 9-months
Locations:
city: Roma
country: Italy
facility: Santa Lucia Foundation I.R.C.C.S.
state: Rm
city: Rome
country: Italy
facility: I.R.C.C.S. "Santa Lucia" Foundation
Study officials:
affiliation: I.R.C.C.S. "Santa Lucia" Foundation
name: Ugo Nocentini, MD
role: STUDY_DIRECTOR
References: