Targeting Subclinical Motor and Cognitive Impairment in Patients With

Targeting Subclinical Motor and Cognitive Impairment in Patients With Early Onset Multiple Sclerosis at High Risk of disEase Acitivity Through a Preventive personaLised and InnovAtive rehaBiLitation stratEgy. (RELIABLE)

Status unknownNot a drug-phase studyRelapsing MSNCT06303024

We could not find results for this trial

What it found

No results found

We found no results in the registry or in papers.

What was tested

Treatment tested

  • personalized combined physical and cognitive intervention

What it measured

Main measures

  • Symbol Digit Modalities Test (SDMT)

    baseline and 1 year followup cohort 1; baseline, 3 months and 1 year followup cohort 2

    Thinking and memory

  • California Verbal Learning Test second edition (CVLT-II)

    baseline and 1year followup cohort 1; baseline, 3 months and 1year followup cohort 2

  • Brief Visuo-Spatial Memory Test- Revised (BVMT-R)

    baseline and 1 year followup cohort 1; baseline, 3 months and 1year followup cohort 2

    Thinking and memory

  • Word list generation (WLG)

    baseline and 1year followup cohort 1; baseline, 3 months and 1year followup cohort 2

  • Stroop test

    baseline and 1year followup cohort 1; baseline, 3 months and 1year followup cohort 2

  • Test Intelligenza Breve (TIB)

    baseline cohort 1 and baseline cohort 2

  • 9 hole peg test (9HPT)

    baseline and 1year followup cohort 1; baseline, 3 months and 1year followup cohort 2

    Disability progressionArm and hand function

  • The Hospital Anxiety and Depression Scale (HADS)

    baseline and 1year followup cohort 1; baseline, 3 months and 1 year followup cohort 2

    Mood and sleep

  • Beck Depression Inventory second edition

    baseline and 1year followup cohort 1; baseline, end 3 months and 1year followup cohort 2

    Mood and sleep

  • The Modified Fatigue Impact Scale (MFIS)

    baseline and 1year followup cohort 1; baseline, 3 months and 1year followup cohort 2

    Fatigue

  • The Multiple Sclerosis Walking Scale (MSWS-12)

    baseline and 1year followup cohort 1; baseline, 3 months and 1year followup cohort 2

    Walking and mobility

  • Multiple Sclerosis Impact Scale (MSIS-29-V2)

    baseline and 1yearfollowup cohort 1; baseline, 3 months and 1year followup cohort 2

    Quality of life (reported by participants)

  • Multiple Sclerosis Quality of Life-54 (MSQOL-54)

    baseline and 1year followup cohort 1; baseline, 3 months and 1year followup cohort 2

    Quality of life (reported by participants)

  • six minutes walking test (6MWT)

    baseline and 1year followup cohort 1; baseline, 3 months and 1year followup cohort 2

    Walking and mobility

  • Romberg test

    baseline and 1year followup cohort 1; baseline, 3 months and 1year followup cohort 2

    Walking and mobility

  • handgrip test

    baseline and 1year followup cohort 1; baseline, 3 months and 1year followup cohort 2

    Arm and hand functionPhysical function

  • cognitive-motor interference

    baseline and 1year followup cohort 1; baseline, 3 months and 1year followup cohort 2

    Thinking and memory

  • Timed 25-foot walk

    baseline and 1year followup cohort 1; baseline, 3 months and 1year followup cohort 2

    Disability progressionWalking and mobility

  • brain MRI scan

    baseline and 1 year followup cohort 1 and 2

    MRI lesions

  • International Physical Activity Questionnaire (IPAQ)

    baseline and 1 year followup cohort 1 and 2

    Physical function

Who could take part

Relapsing MS · 18 and over

Show the full criteria

Inclusion criteria

* diagnosis of RRMS based on the 2017 McDonald criteria; * age ≥ 18 years; * EDSS ≤ 2.0; * disease duration ≤ 5 years; * verification of MS subtype, * duration of disease and EDSS will be accomplished by obtaining a signed consent form for the release of medical information from the treating neurologist.

Exclusion criteria

* history of relevant psychiatric comorbidities. * Severely depressed subjects assessed through the Beck Depression Inventory (scores ≥ 29); * relapses or corticosteroid treatment in the 30 days before inclusion; * history of substance abuse; * presence of non-MS related physical or cognitive impairment that could make the patient unable to complete the study assessments.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

Our project proposal is based on an individualized rehabilitation approach in patients with early stage relapsing remission (RR) MS. This approach will be based on risk stratification obtained using several clinical and demographic parameters that are not commonly used in clinical practice. This risk score will be obtained from an extensive neuropsychological, psychosocial and physical assessment to which patients will undergo at baseline and at one-year follow-up.The risk score will allow a better stratification of patients' risk of disease worsening/progression and the application of a preventive and personalized strategy.

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History

    1. Started

      Jun 2023

    2. Main results due

      Mar 2024

    3. Finished

      Mar 2026

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