EMRESERVA A Program to Enhace Cognitive Reserve in Patients With Multiple Scleorisis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Change in Symbol Digit modality test
研究概览
简要总结
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
详细描述
The cognitive profile is homogeneous in MS. This neuropsychological profile is characterised by impairment of memory ,speed of information processing, attention and executive functions. Periodic cognitive explorations are necessary to assess evolution of patients with MS. This evaluation helps to establish a neuropsychological profile which could help to study cognitive and emotional symptoms of MS. Therefore, using reliable cognitive tests could enable to study neuropsychological disorders associated with MS.
Impact of cognitive impairment on daily routine of people with MS can be diverse and is one of major causes of disability in MS. Therefore is vital to stablished which is the role of cognitive and brain reserve and if they could explain inconsistency between structural damage and cognitive functions in MS.
Attention, information processing speed, working memory, and verbal fluency have a positive impact in cognitive reserve. Therefore, our goal is to assess whether EM-Reserva specific cognitive program have a positive impact in these cognitive functions and maybe could prevent onset of cognitive impairment.
According to Sumowski and Leavitt three activities have a strong association with enhancement of cognitive reserve.
- Cognitive leisure tasks These activities are 1) reading books, 2) reading magazines or newspapers, 3) producing art (for example, painting, poetry or sculpture), 4) writing non-art productions (for example, a newspaper or a blog), 5) playing a musical instrument, 6) playing structured games (for example, cards, board games, crossword puzzles) and 7) engaging in hobbies (for example, gardening, model building and web design).
- Aerobical physical exercises
- Activities that promote social relationships.Gatz and Sumowskihighlighted that the establishment of complex cognitive activities in daily life may be relevant in order to achieve a positive impact in cognitive reserve and delay the onset of cognitive symptoms.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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 >
- •Involved in other psychological intervention trials.
结局指标
主要结局
Change in Symbol Digit modality test
时间窗: at month 6
Change in mean scores. Asociate display symbol to corresponding number. Number of correct responses in 90 seconds
次要结局
- 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 Multiple Sclerosis Quality of Life-54 (MSQOL-54) questionnaire(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)
- Change in Beck depression/anxiety questionnaires(at 6 and 12 months)
- Change in Phonetic and semantic fluencies(at 6 and 12 months)
- Change in MFIS-5(at 6 and 12 months)
- Change in Perceived Deficit Questionnaire (PDQ-5)(at 6 and 12 months)