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EMRESERVA to Enhance Cognitive Reserve in Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT05546424
Recruitment Status : Recruiting
First Posted : September 19, 2022
Last Update Posted : September 19, 2022
Sponsor:
Information provided by (Responsible Party):
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Brief Summary:

Multiple Sclerosis is an immunological degenerative disease that affects the central nervous system causing cognitive impairment as one of the most disabling symptoms, in approximately 40-60% of patients. Cognitive reserve may influence the manifestation of the symptoms of cognitive impairment in MS patients and could justify interindividual differences. Cognitive reserve hypothesis raises that enriching life experiences creates a higher capacity and efficiency of neural networks and protects against cognitive decline in neurological diseases.

Scientific evidence demonstrates that older adults with a higher educational or occupational attainment or engagement in cognitively stimulating leisure activities have a reduced risk of dementia.Systematic reviews report little efficacy of pharmacological and behavioral treatments impairment in cognitive functions in MS patients . As such, the best treatment of cognitive impairment in MS may be the proactive prevention of cognitive decline in the first place Through the application of the EM-Reserva program (that contemplates activities that enhance cognitive reserve as cognitive stimulating leisure activities, social relationships and physical exercise), our goal is to evaluate if it is possible to improve cognitive skills of patients with MS without cognitive impairment versus those who undergo non-specific cognitive exercises. In the short and medium term, EM-Reserva program could improve cognitive performance and delay the appearance or modulate the severity of cognitive impairment in the course of the disease


Condition or disease Intervention/treatment
Cognitive Change Behavioral: EMRESERVA

Show Show detailed description

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Study Type : Observational
Estimated Enrollment : 58 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: EMRESERVA A Program to Enhace Cognitive Reserve in Patients With Multiple Scleorisis
Actual Study Start Date : May 19, 2022
Estimated Primary Completion Date : October 30, 2023
Estimated Study Completion Date : October 30, 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
control

Non-specific cognitive exercises included general advice from MS neuropsychologist specialists on how to manage cognitive difficulties and general cognitives exercises to improve cognitive performance elaborated at our MS Unit, using exercises like sudokus, crosswords and labyrinths.

This control group will require the completion of at least 30 minutes of cognitive exercises daily from Monday to Friday for 5 months. As a complement, patients will be instructed to read newspapers or magazines at least 15 minutes daily.

Behavioral: EMRESERVA
training program will be carried out in groups (up to 6 patients) who will meet one hour once a week for 5 months.

Intervention EMRESERVA

Specific cognitive rehabilitation program "EM-Reserva" will be provided by two specialized MS

Neuropsychologists in groups of 6 participants who will meet approximately an hour weekly, for 5 months."EM reserva" cognitive program includes the following activities:

  1. Cognitive leisure tasks
  2. Physical exercises (workout exercises)
  3. Activities that promote social relationships (social exercises)
Behavioral: EMRESERVA
training program will be carried out in groups (up to 6 patients) who will meet one hour once a week for 5 months.




Primary Outcome Measures :
  1. Change in Symbol Digit modality test [ Time Frame: at month 6 ]
    Change in mean scores. Asociate display symbol to corresponding number. Number of correct responses in 90 seconds


Secondary Outcome Measures :
  1. Change in Trail Making Test form A and B [ Time Frame: at 6 and 12 months. ]
    change in mean scores

  2. Change in BRB-N subtest [ Time Frame: at 6 and 12 months ]
    Change in mean scores

  3. Change in Wechsler Intelligence Scale Vocabulary subtest (WAIS IV) mean scores at 6 and Change in Wechsler Intelligence Scale Vocabulary subtest (WAIS IV) mean scores at 6 and Change in Wechsler Intelligence Scale Vocabulary subtest [ Time Frame: at 6 and 12 months ]
    Change in mean scores

  4. Change in Work memory index (WAIS) [ Time Frame: at 6 and 12 months ]
    Change in mean scores

  5. Change in Tower of London test [ Time Frame: at 6 and 12 months ]
    Change in mean scores

  6. Change in Phonetic and semantic fluencies [ Time Frame: at 6 and 12 months ]
    Change in mean scores

  7. Change in Multiple Sclerosis Quality of Life-54 (MSQOL-54) questionnaire [ Time Frame: at 6 and 12 months ]
    Change in mean scores

  8. Change in Beck depression/anxiety questionnaires [ Time Frame: at 6 and 12 months ]
    Change in mean scores

  9. Change in MFIS-5 [ Time Frame: at 6 and 12 months ]
    Change in mean scores

  10. Change in Perceived Deficit Questionnaire (PDQ-5) [ Time Frame: at 6 and 12 months ]
    Change in mean scores



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients under follow-up in the Multiple Sclerosis unit, diagnosed with RRMS (according to the revised McDonald 2017 criteria) and without cognitive impairment will be selected. The presence or absence of cognitive impairment will be determined according to Amato´s criteria, and defined as the absence of a failure on at least two BRB-N tests, with scores of at least 1.5 SD below the scores of healthy controls
Criteria

Inclusion Criteria:

  • Aged 18-55 years (both inclusive).
  • Relapsing-remitting Multiple Sclerosis (RRMS) according to the 2017 McDonald Revised Criteria with less than 15 years of evolution.
  • Patients with EDSS <3
  • No cognitive impairment on the Brief Neuropsychological Battery of Rao (BRB-N) (Form A) corrected for age and education performed on the last three months in the MS Unit of Hospital Virgen Macarena (UEMAC) according to Amato´s criteria
  • Able to attend group sessions.
  • Patients able to give written Informed Consent.

Exclusion Criteria:

  • Diagnosis of Secondary Progressive or Primary Progressive MS according to McDonald revised criteria (2017)
  • No evidence of relapse or corticosteroid treatment in the 3 months prior to study inclusion.
  • Had vision or hearing problems, such that they were unable to complete the cognitive assessments.
  • Had concurrent severe medical or psychiatric conditions, which prevented them from engaging in treatment and/or Beck Depression Inventory > 20.
  • Involved in other psychological intervention trials.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05546424


Contacts
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Contact: Miriam Ben-Yelun Insenser +34 630832171 miriambenyelun@hotmail.com
Contact: Fundación Pública Andaluza para la gestión de la Investigación

Locations
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Spain
Fundación Pública Andaluza para la gestión de la Investigación en Salud de Sevilla (FISEVI) Recruiting
Sevilla, Andalucía, Spain, 41013
Contact: Miriam Ben-Yelun Insenser    +34 630832171    miriambenyelun@hotmail.com   
Contact: Fundación Pública Andaluza para la gestión de la Investigación         
Sponsors and Collaborators
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Publications of Results:

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Responsible Party: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
ClinicalTrials.gov Identifier: NCT05546424    
Other Study ID Numbers: EMRESERVA
First Posted: September 19, 2022    Key Record Dates
Last Update Posted: September 19, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No