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NCT05546424Completed

EMRESERVA to Enhance Cognitive Reserve in Multiple Sclerosis

EMRESERVA A Program to Enhace Cognitive Reserve in Patients With Multiple Scleorisis

Source: ClinicalTrials.gov · Last updated 7 Feb 2024

Brief summary (registry, in English)

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

Status (registry)
Completed
Study type
Observational
Enrollment
58 (actual)
First submitted
12 May 2022
Start date
19 May 2022
Primary completion date
30 Nov 2023
Lead sponsor
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
NCT number
NCT05546424

What you commit to

  • Study type: Observational
  • Participants enrolled: 58
  • From 19 May 2022 to the primary completion date, 30 Nov 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • No evidence of relapse or corticosteroid treatment in the 3 months prior to study inclusion.
  • Had concurrent severe medical or psychiatric conditions, which prevented them from engaging in treatment and/or Beck Depression Inventory \> 20.

Other

  • 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.
  • Involved in other psychological intervention trials.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 55 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Fundación Pública Andaluza para la gestión de la Investigación en Salud de Sevilla (FISEVI)
Coordinator of this site? Confirm its status
SevilleSpainUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.