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Completed

NCT Number: NCT05462678

Memory Rehabilitation Strategies 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).

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Santa Lucia Foundation I.R.C.C.S., Roma, Rm, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive Rehabilitation

Behavioral

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

Combined Rehabilitation

Behavioral

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

Motor rehabilitation

Behavioral

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

Primary outcomes

  1. Pre- and Post treatment and long term cognitive efficiency

    Time frame: 9-months

    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 outcomes

  1. Pre- and Post-treatment and long term motor efficiency

    Time frame: 9-months

    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.

Other outcomes

  1. Pre- and Post-treatment and long term disability and overall quality of life

    Time frame: 9-months

    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.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jul 18, 2022
Registry last updated
Jul 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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