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临床试验/NCT04787497
NCT04787497进行中(未招募)不适用

The Neuropsychological Effects of Extra-Virgin Olive Oil in People With Multiple Sclerosis

University of Cyprus1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2022年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
46
试验地点
1
主要终点
Symbol Digits Modalities Test (SDMT)

研究概览

简要总结

This is an open label feasibility trial to examine the effect of a complementary treatment with High Phenolic Extra Virgin Olive Oil (HPEVOO) on the cognitive and mental health of people with Multiple Sclerosis (MS), while receiving their standard medical treatment.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of MS
  • Must be between 18 to 65 years of age
  • Both males and females are eligible for participation
  • Must have at least five years of education
  • Must be fluent in Greek language

排除标准

  • Other neurological, psychiatric or chronic condition
  • Enrollment in other trials/drug studies
  • Experiencing side effects from previous treatments
  • Inadequate visual and auditory acuity

结局指标

主要结局

Symbol Digits Modalities Test (SDMT)

时间窗: baseline, 6-months, 12-months

Change will be assessed in the SDMT score (0-100 range), over three time points. Higher score indicates better processing speed.

Wisconsin Card Sorting Test (WCST)

时间窗: baseline, 6-months, 12-months

Change will be assessed in the WCST score over three time points. WCST examines attention, working memory and intellectual flexibility (0-64 score range). Higher scores represent worse performance.

Hospital Anxiety and Depression Scale (HADS)

时间窗: baseline, 6-months, 12-months

Change will be assessed in the HADS scores over three time points. HADS examines anxiety, depression and psychological distress. Higher scores (0-42 range) indicate greater levels of anxiety and depression.

Health Status Questionnaire (SF-36)

时间窗: baseline, 6-months, 12-months

Change will be assessed in SF-36 scores over three time points. SF-36 consists of eight scales (0-100 score range each) that examine physical and mental health-related quality of life. The lower the score the more disability.

Brief Visuospatial Memory Test-Revised (BVMT-R)

时间窗: baseline, 6-months, 12-months

Change will be assessed in the BVMT-R score (0-36 range), over three time points. Higher score indicates better visuospatial memory.

The Vocabulary and Block Design from the Wechsler Adult Intelligence Scale (WAIS)

时间窗: baseline

It will provide an estimated intelligence quotient (IQ) score

Faux Pas Recognition (FPR) Test

时间窗: baseline, 6-months, 12-months

Change will be assessed in the FPR score over three time points. FPR examines social cognition. Four different vignettes will be used for every assessment (0-20 score range). Higher scores indicate better performance.

Modified Fatigue Impact Scale (MFIS)

时间窗: baseline, 6-months, 12-months

Change will be assessed in the MFIS score over three time points. MFIS examines how often fatigue interferes with daily activities. Higher scores (0-84 score range) indicate greater impact of fatigue on a person's activities.

California Verbal Learning Test-Second Edition (CVLT-II)

时间窗: baseline, 6-months, 12-months

Change will be assessed in the CVLT-II score (0-80 range), over three time points. Higher score indicates better auditory-verbal learning.

Trail Making Test (TMT)

时间窗: baseline, 6-months, 12-months

Change will be assessed in the TMT scores over three time points. TMT examines attention, intellectual flexibility and inhibition. Longer time to completion indicates worse performance.

The Digit Span Test (DST) from WAIS

时间窗: baseline, 6-months, 12-months

Change will be assessed in the DST score over three time points. DST examines working memory, 0-48 score range, higher scores indicate better working memory function.

Word List Generation (WLG) Test

时间窗: baseline, 6-months, 12-months

Change will be assessed in the WLG score over three time points. WLG examines lexical fluency. The higher the number of words generated, the better is the performance.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Maria Loizou

Clinical Psychology Doctorate Student

University of Cyprus

研究点 (1)

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