EMRESERVA to Enhance Cognitive Reserve in Multiple Sclerosis

NCT05546424 | Completed DMC

• 1 other identifier: EMRESERVA
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

Multiple Sclerosis(MS) is an immunological degenerative disease that affects central nervous system causing cognitive impairment, which is one of the most disabling symptoms in MS. Cognitive reserve may influence manifestations of 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,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, best treatment of cognitive impairment in MS may be a proactive prevention of cognitive decline in first place Through the application of the EM-Reserva program 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

Conditions

Cognitive Change

Outcome Measures

Primary Outcomes (1)

• Change in Symbol Digit modality test

  Change in mean scores. Asociate display symbol to corresponding number. Number of correct responses in 90 seconds

  at month 6

Secondary Outcomes (10)

• Change in Trail Making Test form A and B

  at 6 and 12 months.

• Change in BRB-N subtest

  at 6 and 12 months

• 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

  at 6 and 12 months

• Change in Work memory index (WAIS)

  at 6 and 12 months

• Change in Tower of London test

  at 6 and 12 months

Study Arms (2)

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

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

Interventions

EMRESERVA BEHAVIORAL

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; control

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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.

You may not qualify if:

• Diagnosis of Secondary Progressive or Primary Progressive MS according to McDonald revised criteria (2017)
• 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.

Sponsors & Collaborators

• Fundación Pública Andaluza para la gestión de la Investigación en Sevilla: lead

Study Sites (1)

Fundación Pública Andaluza para la gestión de la Investigación en Salud de Sevilla (FISEVI)

Seville, Andalusia, 41013, Spain

Location

Related Publications (45)

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Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: September 19, 2022
• Study Start: May 19, 2022
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: February 7, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)