Clinical trial NCT03579017: Edinburgh Cognitive and Behavioural Amyotrophic Lateral Sclerosis Screen in Norway: A Validation Study
Official title: Cognitive Impairment in ALS: Screening Tools, Experiences and Prognosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Amyotrophic Lateral Sclerosis
Cognitive Impairment
Keywords: Amyotrophic lateral sclerosis
Cognitive
Screening
Validation
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
Collaborators: name: Western Norway University of Applied Sciences
First posted: 2018-07-06
Enrollment: 31
Sex: ALL
Minimum age (years): 35
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who fulfill the inclution criteria and attending to the ALS-unit at HUH, St.Olavs Hospital, Hospital of Southern Norway or Namsos Hospital, within 4 months after being diagnosed With ALS.

Healthy People and patients with dementia will constitute Control groups

Brief summary: Cognitive impairment is present in about 30-50% of the patients with amyotrophic lateral sclerosis (ALS). Suitable screening tools are available, but none of these are evaluated in a Norwegian population.

Detailed description: Screening of cognitive and behavioral impairment is a distinct recommendation in ALS-specific health-care. Thus, a rapid screening tool valid for use in Norway is urgent. However, cognitive assessment for patients with ALS can be difficult due to the complexity of cognitive impairment, as well as motor challenges with writing, drawing and speaking. Therefore, only ALS-specific, multi domain screening instruments with integrated behavioral sections should be used. Internationally, the Edinburgh cognitive and behavioral amyotrophic lateral sclerosis screen (ECAS), is recommended for the purpose. Besides being quick and easy to administer, the ECAS is shown to be sensitive and have high specificity to ALS-specific dysfunction and behavioral changes. The introduction of ECAS has probably contributed to a more nuanced picture of cognitive impairment in ALS than previously assumed. Therefore the ECAS has been translated and culturally adapted into Norwegian (ECAS-N). Based on scores from healthy people, Norwegian age- and educational-adjusted norms for verbal fluency (n=277) and cut-off-scores (n=85) for abnormal findings are established. However, further investigation of psychometric properties of the ECAS-N is needed. The objectives of the study are: 1. To investigate if the ECAS-N reflect cognitive impairment (internal consistency), and is robust to measurement errors due to different times of testing (test-retest reliability) and different raters (interrater reliability) 2. To investigate if the ECAS-N can be used to distinguish between people with ALS-specific cognitive impairment, and those who do not have cognitive impairment, and those who have cognitive impairment due to other disorders (construct validity).

Eligibility criteria: Inclusion Criteria:

* voluntary informed consent
* native Norwegian speaker
* aged between 35 and 85 years old (only for Controls)

Exclusion Criteria:

* great difficulties in writing og Reading
* comorbid Medical history
* neurological disorders others than ALS
* psychiatric history of importance to cognitive function

Primary outcomes:
measure: Edinburgh cognitive and behavioural amyotrophic lateral sclerosis screen - Norwegian Version (ECAS-N)
timeFrame: 4 months
Secondary outcomes:
measure: Montreal cognitive assessment (MoCA) - Norwegian version
timeFrame: 4 months
measure: Change from 4 months Edinburgh cognitive and behavioural amyotrophic lateral sclerosis screen - Norwegian Version (ECAS-N) at 8 months
timeFrame: 8 months
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
Study officials:
affiliation: Haukeland University Hospital
name: Tina Taule, PhD
role: PRINCIPAL_INVESTIGATOR
References: