Multiple Sclerosis, Relapsing-RemittingRELIABLENCT06303024
Targeting Subclinical Motor and Cognitive Impairment in Patients With Early Onset Multiple Sclerosis
A study testing personalized combined physical and cognitive intervention in people with Multiple Sclerosis, Relapsing-Remitting, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting
- What is being tested?
- personalized combined physical and cognitive intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteItaly
- Study dates
- 14 Jun 2023to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Fondazione Don Carlo Gnocchi ONLUS
Florence, 50143
Maria Pia Amato, Prof, 0557947836, mpamato@dongnocchi.it
About this study
Official title: 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.
Read the 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.
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Being tested
- personalized combined physical and cognitive intervention
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
personalized combined physical and cognitive interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| personalized combined physical and cognitive intervention | Experimental | 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. Receives: Other: personalized combined physical and cognitive intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symbol Digit Modalities Test (SDMT)
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.
Measured: baseline and 1 year followup cohort 1; baseline, 3 months and 1 year followup cohort 2
California Verbal Learning Test second edition (CVLT-II)
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.
Measured: baseline and 1year followup cohort 1; baseline, 3 months and 1year followup cohort 2
Brief Visuo-Spatial Memory Test- Revised (BVMT-R)
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.
Measured: baseline and 1 year followup cohort 1; baseline, 3 months and 1year followup cohort 2
Word list generation (WLG)
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
Measured: baseline and 1year followup cohort 1; baseline, 3 months and 1year followup cohort 2
Stroop test
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
Measured: baseline and 1year followup cohort 1; baseline, 3 months and 1year followup cohort 2
Test Intelligenza Breve (TIB)
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
Measured: baseline cohort 1 and baseline cohort 2
9 hole peg test (9HPT)
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
Measured: baseline and 1year followup cohort 1; baseline, 3 months and 1year followup cohort 2
The Hospital Anxiety and Depression Scale (HADS)
to measure anxiety and depression
Measured: baseline and 1year followup cohort 1; baseline, 3 months and 1 year followup cohort 2
Beck Depression Inventory second edition
to measure depression
Measured: baseline and 1year followup cohort 1; baseline, end 3 months and 1year followup cohort 2
The Modified Fatigue Impact Scale (MFIS)
to measure fatigue
Measured: baseline and 1year followup cohort 1; baseline, 3 months and 1year followup cohort 2
The Multiple Sclerosis Walking Scale (MSWS-12)
evaluate the participants subjective impact of walking.
Measured: baseline and 1year followup cohort 1; baseline, 3 months and 1year followup cohort 2
Multiple Sclerosis Impact Scale (MSIS-29-V2)
to evaluate the participants impact of Multiple Sclerosis.
Measured: baseline and 1yearfollowup cohort 1; baseline, 3 months and 1year followup cohort 2
Multiple Sclerosis Quality of Life-54 (MSQOL-54)
to evaluate quality of life
Measured: baseline and 1year followup cohort 1; baseline, 3 months and 1year followup cohort 2
six minutes walking test (6MWT)
to measure the distance a subject can travel by walking as fast as possible on a flat surface in six minutes.
Measured: baseline and 1year followup cohort 1; baseline, 3 months and 1year followup cohort 2
Romberg test
to assess balance
Measured: baseline and 1year followup cohort 1; baseline, 3 months and 1year followup cohort 2
handgrip test
a strength evaluation test
Measured: baseline and 1year followup cohort 1; baseline, 3 months and 1year followup cohort 2
cognitive-motor interference
impact of a simple cognitive test - verbal fluency on a randomly extracted letter - on motor performances
Measured: baseline and 1year followup cohort 1; baseline, 3 months and 1year followup cohort 2
Timed 25-foot walk
is a quantitative mobility and leg function performance test based on a timed 25-walk.
Measured: baseline and 1year followup cohort 1; baseline, 3 months and 1year followup cohort 2
brain MRI scan
to evaluate the presence of new/enlarging T2 lesions, new gadolinium-positive lesions, and volumetric analyses
Measured: baseline and 1 year followup cohort 1 and 2
International Physical Activity Questionnaire (IPAQ)
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.
Measured: baseline and 1 year followup cohort 1 and 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start14 Jun 2023
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis, Relapsing-RemittingStudies of the same condition, open and under way.
- More trials run by Fondazione Don Carlo Gnocchi ETSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- This is a multicentric no-profit pilot study, composed by two phases. I phase: observational prospective study II phase: interventional study
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Collaborators
- Careggi Hospital, Sheba Medical Center, Uppsala University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06303024
- Sponsor's protocol ID
- RELIABLE Clinical Study
- Acronym
- RELIABLE
- Status last verified
- Feb 2024
- First submitted
- 4 Mar 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06303024
- Acronym / sponsor ID
- RELIABLE / RELIABLE Clinical Study
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Collaborators
- Careggi Hospital, Sheba Medical Center, Uppsala University
- Study start
- 14 Jun 2023 (actual)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a multicentric no-profit pilot study, composed by two phases. I phase: observational prospective study II phase: interventional study
| Arm | Type | Receives |
|---|---|---|
| personalized combined physical and cognitive intervention | Experimental | Other: personalized combined physical and cognitive interventionThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- diagnosis of RRMS based on the 2017 McDonald criteria;
- age ≥ 18 years;
- EDSS ≤ 2.0;
- disease duration ≤ 5 years;
- verification of MS subtype,
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| personalized combined physical and cognitive interventionThe 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. | Other | personalized combined physical and cognitive intervention |
Primary outcome
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.
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.
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.
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
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
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
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
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
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
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
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.
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.
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
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.
Romberg test
Time frame: baseline and 1year followup cohort 1; baseline, 3 months and 1year followup cohort 2
to assess balance
handgrip test
Time frame: baseline and 1year followup cohort 1; baseline, 3 months and 1year followup cohort 2
a strength evaluation test
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
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.
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
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing personalized combined physical and cognitive intervention in people with Multiple Sclerosis, Relapsing-Remitting, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Pia Amato, Prof (0557947836, mpamato@dongnocchi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symbol Digit Modalities Test (SDMT) (time frame: baseline and 1 year followup cohort 1; baseline, 3 months and 1 year followup cohort 2). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.