Assessment of Attentional and Executive Disorders in Multiple Sclerosis Using Techniques of Virtual Reality
概览
- 阶段
- 不适用
- 干预措施
- Assessment of attentional functions by traditional tests
- 疾病 / 适应症
- Relapsing-Remitting Multiple Sclerosis
- 发起方
- University Hospital, Caen
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Scores for traditional tests
- 状态
- 已完成
- 最后更新
- 2个月前
概览
简要总结
Since many years cognitive disorders are a main topic of clinical research in Multiple Sclerosis (MS) as there could be observed early on in the disease and could induce with time in patients significant socio-professional burden. Today assessment of cognitive dysfunction in MS is still based on traditional pencil-paper task tests which are not able to give a true representation of functional burden observed in patients in real life situations. The development of new tools close to these "life situations", i.e. more ecological, are needed to better assess and take in charge cognitive impairment in MS patients. One way to reach this goal is Virtual Reality (VR). VR offers a new human-computer interface paradigm that simulates a realistic 3D environment where the user become immersed and interacts with it. These last ten years VR has known a rapid development in the health domain and has been applied with success to motor rehabilitation, psychiatry and neuropsychology. In this last domain, virtual environment (VE) reproducing activities of daily living have been used to evaluate executive and memory functions as well as attentional or visuospatial processes. Among main VE developed, driving assessment system, navigation skills, cooking behaviors, virtual supermarket have shown better sensitivity to detect functional consequences of cognitive impairment in various neurological and psychiatric disorders than traditional evaluations. In Caen University Hospital, investigators used VE driving system and developed the use of the Virtual Action Planning in a supermarket (VAP-S ; Klinger et al 2004) where a user move to select and buy groceries and other things inside an interactive virtual supermarket using a shopping cart. In a preliminary study investigators have used this virtual interactive tool to evaluate executive functioning in small group of Parkinson's disease and MS patients. Analysis of initial data shows the feasibility of the VAP-S for use with these two kinds of diseases. According to these results investigators planned a new study in Relapsing-Remitting(RR)- MS patients where they compare the use of VE (driving system and the VAP-S) to traditional attentional and executive evaluation for estimate their respective sensitivity to detect cognitive/functional impairment in MS patients. Investigators hope to shown that VR will demonstrate its interest to assess cognitive functions in MS and to develop cognitive rehabilitation.
研究者
入排标准
入选标准
- •Patients only :
- •Diagnosis of RR-MS in accordance with the Polman et al. criteria (2011)
- •Expanded Disability Status Scale (EDSS) \< 6
- •Any disease duration
- •Patients and healthy subjects :
- •Men and women
- •Ages 30-60 years inclusive
- •Score of \> 130 on the Mattis Dementia Rating Scale (DRS)
- •Score of \< 15 on the Montgomery and Asberg Depression Rating Scale (MADRS)
- •French native language
排除标准
- •Patients only :
- •Any relapse or corticosteroids therapy within 30 days
- •Under guardianship
- •Patients and healthy subjects
- •Other neurological, psychiatric or developmental disease
- •Serious systemic disease
- •Sequelae of brain injury
- •Antidepressants or anxiolytics treatment within 4 weeks
- •Treatment known to interfere with cognition (e.g. psychostimulant) within 3 months
- •Alcohol \> 28 units / week
研究组 & 干预措施
Arm A
Inclusion : cognitive complaint,fatigue, anxiety an depression questionnaires. Assessment 1 : attentional function by traditional tests + executive function by virtual reality tests. One week later, Assessment 2 : attentional function by virtual reality tests + executive function by traditional tests.
干预措施: Assessment of attentional functions by traditional tests
Arm A
Inclusion : cognitive complaint,fatigue, anxiety an depression questionnaires. Assessment 1 : attentional function by traditional tests + executive function by virtual reality tests. One week later, Assessment 2 : attentional function by virtual reality tests + executive function by traditional tests.
干预措施: Assessment of attentional functions by virtual reality tests
Arm A
Inclusion : cognitive complaint,fatigue, anxiety an depression questionnaires. Assessment 1 : attentional function by traditional tests + executive function by virtual reality tests. One week later, Assessment 2 : attentional function by virtual reality tests + executive function by traditional tests.
干预措施: Assessment of executive functions by traditional tests
Arm A
Inclusion : cognitive complaint,fatigue, anxiety an depression questionnaires. Assessment 1 : attentional function by traditional tests + executive function by virtual reality tests. One week later, Assessment 2 : attentional function by virtual reality tests + executive function by traditional tests.
干预措施: Assessment of executive functions by virtual reality test
Arm A
Inclusion : cognitive complaint,fatigue, anxiety an depression questionnaires. Assessment 1 : attentional function by traditional tests + executive function by virtual reality tests. One week later, Assessment 2 : attentional function by virtual reality tests + executive function by traditional tests.
干预措施: Evaluation of cognitive complaint, fatigue, anxiety and depression
Arm B
Inclusion : cognitive complaint,fatigue, anxiety an depression questionnaires. Assessment 1 : attentional function by virtual reality tests + executive function by traditional tests. One week later, Assessment 2 : attentional function by traditional tests + executive function by virtual reality tests.
干预措施: Assessment of attentional functions by traditional tests
Arm B
Inclusion : cognitive complaint,fatigue, anxiety an depression questionnaires. Assessment 1 : attentional function by virtual reality tests + executive function by traditional tests. One week later, Assessment 2 : attentional function by traditional tests + executive function by virtual reality tests.
干预措施: Assessment of attentional functions by virtual reality tests
Arm B
Inclusion : cognitive complaint,fatigue, anxiety an depression questionnaires. Assessment 1 : attentional function by virtual reality tests + executive function by traditional tests. One week later, Assessment 2 : attentional function by traditional tests + executive function by virtual reality tests.
干预措施: Assessment of executive functions by traditional tests
Arm B
Inclusion : cognitive complaint,fatigue, anxiety an depression questionnaires. Assessment 1 : attentional function by virtual reality tests + executive function by traditional tests. One week later, Assessment 2 : attentional function by traditional tests + executive function by virtual reality tests.
干预措施: Assessment of executive functions by virtual reality test
Arm B
Inclusion : cognitive complaint,fatigue, anxiety an depression questionnaires. Assessment 1 : attentional function by virtual reality tests + executive function by traditional tests. One week later, Assessment 2 : attentional function by traditional tests + executive function by virtual reality tests.
干预措施: Evaluation of cognitive complaint, fatigue, anxiety and depression
结局指标
主要结局
Scores for traditional tests
时间窗: 2 visits over 1 week
For each test, scores will be compared between patients and healthy subjects.
Scores for virtual reality tests
时间窗: 2 visits over 1 week
For each test, scores will be compared between patients and healthy subjects.
Correlation between traditional and virtual reality tests
时间窗: 2 visits over 1 week
Links between scores for traditional tests and scores for virtual reality tests will assessed by calculating Pearson or Spearman correlation coefficents, among all participants.
Z-scores for traditional and virtual reality tests
时间窗: 2 visits over 1 week
For each patient and each score, z-score will be calculated. For traditional and virtual reality tests for which a correlation will be observed, the z-scores will be compared.
次要结局
- Score for cognitive complaint questionnaire(Inclusion visit)
- Scores for fatigue, anxiety and depression questionnaires(inclusion visit)