跳至主要内容
临床试验/NCT03578796
NCT03578796进行中(未招募)不适用

Cognitive Impairment in ALS: Screening Tools, Experiences and Prognosis

Haukeland University Hospital1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2017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)
发起方
入组人数
31
试验地点
1
主要终点
Clinical Dementia Rating (CDR)

研究概览

简要总结

This study evaluate use of a translated Norwegian version of the Edinburgh cognitive and behavioral amyotrophic lateral sclerosis screen (ECAS-N) as an early predictor in car-driving, working and use of advanced life-prolonging therapy.

详细描述

Cognitive impairment is present in about 30-50% of the patients with amyotrophic lateral sclerosis (ALS). Screening of cognitive and behavioral impairment is a distinct recommendation in ALS-specific health care. However, knowledge in how cognitive impairment shall influence health-care professionals' information given to patients and in decision making is lacking.

One of the major challenges in ALS management is the decision-making on advanced therapy. There is a lack of knowledge in how cognitive impairment in ALS shall be interfere on complex medical treatment that will affect quality of life or life itself. This means significant implications not only to the ALS patient and the community, but also the family and especially the spouse. Thus, further investigation of the ECAS-N and its potential in clinical use is needed. The scale may contribute a more proactive treatment better tailored to individual needs. The objective is to evaluate if the ECAS-N can be applied as an early predictor in car-driving, working and use of advanced life-prolonging therapy

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Voluntary informed consent
  • Native Norwegian speaker

排除标准

  • Great difficulties in writing or reading
  • Comorbid medical history
  • Neurological disorders others than ALS
  • Psychiatric history of importance to cognitive function

结局指标

主要结局

Clinical Dementia Rating (CDR)

时间窗: 8 months

We will use the total CDR score (minimum score = 0, maximum score = 18). Low scores indicate less problems than high scores.

次要结局

  • Ability in car-driving(3 years or until death)
  • Use of Advanced life-prolonging therapy(3 years or until death)
  • Clinical Dementia Rating (CDR)(3 years or until death)
  • Working ability(3 years or until death)

研究者

发起方
Haukeland University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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