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NCT Number: NCT03578796

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Amyotrophic Lateral Sclerosis Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Cognitive Impairment Mental Disorders Metabolic Diseases Motor Neuron Disease Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies Spinal Cord Diseases TDP-43 Proteinopathies

Sex eligibility

All sexes

Study type

Observational

Primary location

Haukeland University Hospital

Bergen, 5021, Norway

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ECAS-N

Diagnostic Test

assessing ALS-specific cognitive impairment

Other names: Edinburgh cognitive and behavioural ALS screen

MoCA

Diagnostic Test

assessing cognitive impairment

Other names: Montreal cognitive assessment

CDR

Diagnostic Test

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

Other names: Clinical dementia rating

Questionnaire

Other

Questions related to work situation and car driving

Primary outcomes

  1. Clinical Dementia Rating (CDR)

    Time frame: 8 months

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

Secondary outcomes

  1. Clinical Dementia Rating (CDR)

    Time frame: 4 months

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

  2. Clinical Dementia Rating (CDR)

    Time frame: 3 years or until death

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

  3. Ability in car-driving

    Time frame: 8 months

    We will use a categorical variable (yes or no) and time of change to reduced function.

  4. Ability in car-driving

    Time frame: 4 months

    We will use a categorical variable (yes or no) and time of change to reduced function.

  5. Ability in car-driving

    Time frame: 3 years or until death

    We will use a categorical variable (yes or no) and time of change to reduced function.

  6. Working ability

    Time frame: 8 months

    We will use a categorical variable (yes or no) and time of change to reduced function.

  7. Working ability

    Time frame: 4 months

    We will use a categorical variable (yes or no) and time of change to reduced function.

  8. Working ability

    Time frame: 3 years or until death

    We will use a categorical variable (yes or no) and time of change to reduced function.

  9. Use of Advanced life-prolonging therapy

    Time frame: 8 months

    We will use a categorical variable (yes or no) and time of change to reduced function.

  10. Use of Advanced life-prolonging therapy

    Time frame: 4 months

    We will use a categorical variable (yes or no) and time of change to reduced function.

  11. Use of Advanced life-prolonging therapy

    Time frame: 3 years or until death

    We will use a categorical variable (yes or no) and time of change to reduced function.

Other outcomes

  1. Edinburgh cognitive and behavioral amyotrophic lateral sclerosis screen-Norwegian Version (ECAS-N)

    Time frame: 4 months

    We will use the ALS-specific sub-score (minimum score = 0, maximum score = 100), the ALS non-specific sub-score (minimum score = 0, maximum score = 36), a summed total ECAS-N score (minimum score =0, maximum score =136), the sub score of behavioural changes (minimum score = 0, maximum score = 10) and the sub score of psychotic change (minimum score = 0, maximum score = 3). A dichotomized cut-off scores for normality will also be used for the ALS-specific cut-off score of 65 or over, the non ALS-specific cut-off score of 24 or over and the total ECAS-N cut-off score of 92 or over. For the ALS-specific scores, non ALS-specific scores and total ECAS-N scores, high scores indicate less problems than low scores. For the sub score of behavioural change and the sub score of psychotic change, high scores indicate more problems than low scores.

  2. Change from 4 months Edinburgh cognitive and behavioral amyotrophic lateral sclerosis screen-Norwegian Version (ECAS-N) at 8 months

    Time frame: 8 months

    We will use the changed ALS-specific sub-score (minimum score = 0, maximum score = 100), the changed ALS non-specific sub-score (minimum score = 0, maximum score = 36), a changed summed total ECAS-N score (minimum score =0, maximum score =136), the changed sub score of behavioural changes (minimum score = 0, maximum score = 10) and the changed sub score of psychotic change (minimum score = 0, maximum score = 3). A changed dichotomized cut-off scores for normality will also be used for the ALS-specific cut-off score of 65 or over, the non ALS-specific cut-off score of 24 or over and the total ECAS-N cut-off score of 92 or over. For the ALS-specific scores, non ALS-specific scores and total ECAS-N scores, high scores indicate less problems than low scores. For the sub score of behavioural change and the sub score of psychotic change, high scores indicate more problems than low scores.

  3. Montreal Cognitive Assessment (MoCA)

    Time frame: 4 months

    We will use the total MoCA score (minimum score = 0, maximum score = 30) and a dichotomized cut-off score for normality of 26 or over. High scores indicate less problems than low scores

  4. Change from 4 months Montreal Cognitive Assessment (MoCA) at 8 months

    Time frame: 8 months

    We will use the changed total MoCA score (minimum score = 0, maximum score = 30) and the changed dichotomized cut-off score for normality of 26 or over. High scores indicate less problems than low scores

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Collaborators

  • Western Norway University of Applied Sciences

Registry information

Official study title

Cognitive Impairment in ALS: Screening Tools, Experiences and Prognosis

Important dates

Study start
2017
Primary completion
2022
Study completion
2026
First posted
Jul 6, 2018
Registry last updated
Oct 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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