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

Cognitive Impairment in ALS: Screening Tools, Experiences and Prognosis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03578796
Enrollment
31
Registered
2018-07-06
Start date
2017-05-01
Completion date
2026-10-05
Last updated
2026-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyotrophic Lateral Sclerosis, Cognitive Impairment

Keywords

Amyotrophic Lateral Sclerosis, Cognitive, Predictor

Brief summary

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.

Detailed description

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

Interventions

DIAGNOSTIC_TESTECAS-N

assessing ALS-specific cognitive impairment

DIAGNOSTIC_TESTMoCA

assessing cognitive impairment

DIAGNOSTIC_TESTCDR

assessing global cognitive impairment, as well as possible diagnosis- and Level of dementia

OTHERQuestionnaire

Questions related to work situation and car driving

Sponsors

Haukeland University Hospital
Lead SponsorOTHER
Western Norway University of Applied Sciences
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Voluntary informed consent * Native Norwegian speaker

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Clinical Dementia Rating (CDR)8 monthsWe will use the total CDR score (minimum score = 0, maximum score = 18). Low scores indicate less problems than high scores.

Secondary

MeasureTime frameDescription
Clinical Dementia Rating (CDR)4 monthsWe will use the total CDR score (minimum score = 0, maximum score = 18). Low scores indicate less problems than high scores.
Ability in car-driving8 monthsWe will use a categorical variable (yes or no) and time of change to reduced function.
Working ability8 monthsWe will use a categorical variable (yes or no) and time of change to reduced function.
Use of Advanced life-prolonging therapy8 monthsWe will use a categorical variable (yes or no) and time of change to reduced function.

Countries

Norway

Contacts

PRINCIPAL_INVESTIGATORTina Taule, PhD

Haukeland University Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Oct 7, 2026