Targeting Subclinical Motor and Cognitive Impairment in Patients With Early Onset Multiple Sclerosis (RELIABLE)

March 8, 2024 updated by: Fondazione Don Carlo Gnocchi Onlus

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)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a multicentric no-profit pilot study, composed by two phases. The objective of the first phase is to create a multi-factorial assessment and prognostic profiling into different risk categories, integrating different techniques in a common evaluation approach. MS patients, referred to the MS Centers of Careggi University Hospital and the Sheba Medical Centre in Tel-Aviv, will be recruit and assess at baseline and 12-months follow-up using a comprehensive approach. The patients will undergo an advanced motor performance evaluation, neuropsychological assessment, and a brain MRI scan to evaluate the presence of new/enlarging T2 lesions, new gadolinium-positive lesions, and volumetric analyses (e.g., total brain volume, grey matter volume, white matter volume, T2 lesions volume, normalized thalamic and hippocampal volume). Data collected from the comprehensive baseline and 12 months assessment will be used to generate a risk score for disease worsening in the short-term, classifying the patients into low/mild, moderate, or high risk. All the variables significantly associated with disease activity will be combined in the risk score.The objectives of II Phase are to apply the previously obtained risk score on a novel cohort using the same inclusion/exclusion criteria; to evaluate the impact of a combined rehabilitation approach in reducing the proportion of patients with disease activity.The risk score obtained from follow-up data of the test cohort applied to the newly recruited patients. Only patients with moderate to high risk of worsening in this new cohort will be included in the rehabilitation program. The included patients will receive an innovative and personalized rehabilitation approach, including counselling on lifestyle habits, an aerobic moderate to high-intensity physical training and a computerized cognitive rehabilitation program.The efficacy of the rehabilitation approach will be then evaluated by comparing patients included in this cohort with patients in the same risk groups included in the phase 1 cohort. Across Phases of the study, Uppsala University partner, will conduct a surveillance and will consider Social and ethical aspects of the integrated rehabilitation approach. Personalized preventive interventions and tailored risk information may raise pressing ethical issues that need careful reflection.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
140

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Italy
      • Firenze, Italy, 50143
        • Recruiting
        • IRCCS Fondazione Don Carlo Gnocchi ONLUS
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: personalized combined physical and cognitive intervention
The exercise intervention will be aerobic and performed on a stationary bicycle and will comply with the basic principle of progressive overload, combined with a computer based cognitive rehabilitation program carried out twice a week for 12 weeks, using the Rehacom software.
Other: personalized combined physical and cognitive intervention
The exercise intervention will be aerobic and performed on a stationary bicycle and will comply with the basic principle of progressive overload. An incremental exercise test until exhaustion on a bicycle ergometer will be applied to determine directly measured VO2-max in order to customize and personalize the training on each patient. The progressive aerobic exercise (PAE) will last 12 weeks with two sessions per week. Continuous training will be alternated with interval training during the program. The intervention included two weekly training sessions. One session will involve continuous exercise initially commencing at 10 min and progressing towards 30 min/session. Ultimately, a computer based cognitive rehabilitation program will be carried out twice a week for 12 weeks, using the Rehacom software. Participants will begin at level 1 on each RehaCom module and advance through the program as dictated by their performance. Each session will be programmed to last 60 minutes.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Symbol Digit Modalities Test (SDMT)
Time Frame: baseline and 1 year followup cohort 1; baseline, 3 months and 1 year followup cohort 2
The SDMT is a simple matching task that requires the participant to refer to a reference key, in order to correctly match a geometric symbol with the corresponding number. Participant will be under a 90 second time constraint to quickly and correctly match each pair.
baseline and 1 year followup cohort 1; baseline, 3 months and 1 year followup cohort 2
California Verbal Learning Test second edition (CVLT-II)
Time Frame: baseline and 1year followup cohort 1; baseline, 3 months and 1year followup cohort 2
The CVLT test begins with the examiner reading a list of 16 words, participants are then instructed to report as many of the words as they can remember. After recall is recorded, the entire list is read again, altogether, there are five learning trials.
baseline and 1year followup cohort 1; baseline, 3 months and 1year followup cohort 2
Brief Visuo-Spatial Memory Test- Revised (BVMT-R)
Time Frame: baseline and 1 year followup cohort 1; baseline, 3 months and 1year followup cohort 2
Participants are presented with six abstract designs for 10 seconds, the display is then removed from view and participant are instructed to draw the designs from memory via pencil on paper. Each design is scored from 0 to 2 points representing accuracy and location. There are three learning trials.
baseline and 1 year followup cohort 1; baseline, 3 months and 1year followup cohort 2
Word list generation (WLG)
Time Frame: baseline and 1year followup cohort 1; baseline, 3 months and 1year followup cohort 2
the subject has to say as many words from the fruit and vegetable categories as they can think of in one and a half minutes
baseline and 1year followup cohort 1; baseline, 3 months and 1year followup cohort 2
Stroop test
Time Frame: baseline and 1year followup cohort 1; baseline, 3 months and 1year followup cohort 2
the reading time of the stimuli in the interference condition is assessed: there are colours written but the colour of the ink is different from the written word, the subject has to say the colour of the ink in which the word is written
baseline and 1year followup cohort 1; baseline, 3 months and 1year followup cohort 2
Test Intelligenza Breve (TIB)
Time Frame: baseline cohort 1 and baseline cohort 2
evaluation of the IQ estimation, the subject reads words with regular and irregular accents and takes the number of errors of words with irregular accents
baseline cohort 1 and baseline cohort 2
9 hole peg test (9HPT)
Time Frame: baseline and 1year followup cohort 1; baseline, 3 months and 1year followup cohort 2
to measure finger dexterity, the subject must take the pegs one at a time with the dominant hand and then with the other hand and insert them as quickly as possible into the holes and remove them
baseline and 1year followup cohort 1; baseline, 3 months and 1year followup cohort 2
The Hospital Anxiety and Depression Scale (HADS)
Time Frame: baseline and 1year followup cohort 1; baseline, 3 months and 1 year followup cohort 2
to measure anxiety and depression
baseline and 1year followup cohort 1; baseline, 3 months and 1 year followup cohort 2
Beck Depression Inventory second edition
Time Frame: baseline and 1year followup cohort 1; baseline, end 3 months and 1year followup cohort 2
to measure depression
baseline and 1year followup cohort 1; baseline, end 3 months and 1year followup cohort 2
The Modified Fatigue Impact Scale (MFIS)
Time Frame: baseline and 1year followup cohort 1; baseline, 3 months and 1year followup cohort 2
to measure fatigue
baseline and 1year followup cohort 1; baseline, 3 months and 1year followup cohort 2
The Multiple Sclerosis Walking Scale (MSWS-12)
Time Frame: baseline and 1year followup cohort 1; baseline, 3 months and 1year followup cohort 2
evaluate the participants subjective impact of walking.
baseline and 1year followup cohort 1; baseline, 3 months and 1year followup cohort 2
Multiple Sclerosis Impact Scale (MSIS-29-V2)
Time Frame: baseline and 1yearfollowup cohort 1; baseline, 3 months and 1year followup cohort 2
to evaluate the participants impact of Multiple Sclerosis.
baseline and 1yearfollowup cohort 1; baseline, 3 months and 1year followup cohort 2
Multiple Sclerosis Quality of Life-54 (MSQOL-54)
Time Frame: baseline and 1year followup cohort 1; baseline, 3 months and 1year followup cohort 2
to evaluate quality of life
baseline and 1year followup cohort 1; baseline, 3 months and 1year followup cohort 2
six minutes walking test (6MWT)
Time Frame: baseline and 1year followup cohort 1; baseline, 3 months and 1year followup cohort 2
to measure the distance a subject can travel by walking as fast as possible on a flat surface in six minutes.
baseline and 1year followup cohort 1; baseline, 3 months and 1year followup cohort 2
Romberg test
Time Frame: baseline and 1year followup cohort 1; baseline, 3 months and 1year followup cohort 2
to assess balance
baseline and 1year followup cohort 1; baseline, 3 months and 1year followup cohort 2
handgrip test
Time Frame: baseline and 1year followup cohort 1; baseline, 3 months and 1year followup cohort 2
a strength evaluation test
baseline and 1year followup cohort 1; baseline, 3 months and 1year followup cohort 2
cognitive-motor interference
Time Frame: baseline and 1year followup cohort 1; baseline, 3 months and 1year followup cohort 2
impact of a simple cognitive test - verbal fluency on a randomly extracted letter - on motor performances
baseline and 1year followup cohort 1; baseline, 3 months and 1year followup cohort 2
Timed 25-foot walk
Time Frame: baseline and 1year followup cohort 1; baseline, 3 months and 1year followup cohort 2
is a quantitative mobility and leg function performance test based on a timed 25-walk.
baseline and 1year followup cohort 1; baseline, 3 months and 1year followup cohort 2
brain MRI scan
Time Frame: baseline and 1 year followup cohort 1 and 2
to evaluate the presence of new/enlarging T2 lesions, new gadolinium-positive lesions, and volumetric analyses
baseline and 1 year followup cohort 1 and 2
International Physical Activity Questionnaire (IPAQ)
Time Frame: baseline and 1 year followup cohort 1 and 2
to assess the types of intensity of physical activity and sitting time that people do as part of their daily lives are considered to estimate total physical activity in MET-min/week and time spent sitting.
baseline and 1 year followup cohort 1 and 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fondazione Don Carlo Gnocchi Onlus

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Uppsala University
Sheba Medical Center
Careggi Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 14, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 4, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 12, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 12, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RELIABLE Clinical Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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