Edinburgh Cognitive and Behavioural Amyotrophic Lateral Sclerosis Screen in Norway: A Validation Study

Haukeland University Hospital

Status: Completed

Conditions: Cognitive Impairment; Amyotrophic Lateral Sclerosis

Treatments: Diagnostic Test: MoCA; Diagnostic Test: ECAS-N

Study type: Observational

Funder types: Other

Identifiers

NCT03579017

2016/3166

Details and patient eligibility

About

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.

Full 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).

Enrollment: 31 patients

Sex: All

Ages: 35 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

31 participants in 3 patient groups

Patients with ALS

Description:

Patients with ALS will be tested by two independent testers with the ECAS-N at 4 months (baseline) and 8 months (follow-up), and the MoCA at 4 months (baseline) by one tester

Treatment:

Diagnostic Test: ECAS-N

Diagnostic Test: MoCA

Healthy controls

Description:

Persons with no cognitive impairment will be tested with the ECAS-N once, by one tester

Treatment:

Diagnostic Test: ECAS-N

Controls with dementia

Description:

Persons with cognitive impairment due to other disorders will be tested with the ECAS-N once, by one tester

Treatment:

Diagnostic Test: ECAS-N