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

NCT ID: NCT03579017

Last Updated: 2024-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

31 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-01

Study Completion Date

2023-05-04

Brief Summary

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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

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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).

Conditions

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Amyotrophic Lateral Sclerosis Cognitive Impairment

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with ALS

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

ECAS-N

Intervention Type DIAGNOSTIC_TEST

All participants included will be tested with the ECAS-N

MoCA

Intervention Type DIAGNOSTIC_TEST

All included patients With ALS will be tested With the MoCA

Healthy controls

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

ECAS-N

Intervention Type DIAGNOSTIC_TEST

All participants included will be tested with the ECAS-N

Controls with dementia

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

ECAS-N

Intervention Type DIAGNOSTIC_TEST

All participants included will be tested with the ECAS-N

Interventions

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ECAS-N

All participants included will be tested with the ECAS-N

Intervention Type DIAGNOSTIC_TEST

MoCA

All included patients With ALS will be tested With the MoCA

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Edinburgh cognitive and behavioral ALS screen (Norwegian) Montreal cognitive assessment (MoCA)

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Western Norway University of Applied Sciences

OTHER

Sponsor Role collaborator

Haukeland University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tina Taule, PhD

Role: PRINCIPAL_INVESTIGATOR

Haukeland University Hospital

Locations

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Haukeland University Hospital

Bergen, , Norway

Site Status

Countries

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Norway

Other Identifiers

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2016/3166

Identifier Type: -

Identifier Source: org_study_id

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