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

NCT06303024 | Recruiting

• 1 other identifier: RELIABLE Clinical Study
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Multiple Sclerosis, Relapsing-Remitting

Outcome Measures

Primary Outcomes (20)

• 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.

  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.

  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.

  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

  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

  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

  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

  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

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

• Beck Depression Inventory second edition

  to measure depression

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

• The Modified Fatigue Impact Scale (MFIS)

  to measure fatigue

  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.

  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.

  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

  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.

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

• Romberg test

  to assess balance

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

• handgrip test

  a strength evaluation test

  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

  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.

  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

  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.

  baseline and 1 year followup cohort 1 and 2

Study Arms (1)

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.

Other: personalized combined physical and cognitive intervention

Interventions

personalized combined physical and cognitive intervention OTHER

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.

personalized combined physical and cognitive intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead
• Careggi Hospital: collaborator
• Sheba Medical Center: collaborator
• Uppsala University: collaborator

Study Sites (1)

IRCCS Fondazione Don Carlo Gnocchi ONLUS

Florence, 50143, Italy

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Maria Pia Amato, Prof

CONTACT

0557947836; mpamato@dongnocchi.it

Claudia Niccolai, PSY

CONTACT

0557947836; clniccolai@DONGNOCCHI.IT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a multicentric no-profit pilot study, composed by two phases. I phase: observational prospective study II phase: interventional study

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 12, 2024
• Study Start: June 14, 2023
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2026
• Last Updated: March 12, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)