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

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ClinicalTrials.gov Identifier: NCT03578796
Recruitment Status : Recruiting
First Posted : July 6, 2018
Last Update Posted : July 6, 2018
Sponsor:
Collaborator:
Western Norway University of Applied Sciences
Information provided by (Responsible Party):
Haukeland University Hospital

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.

Condition or disease Intervention/treatment
Amyotrophic Lateral Sclerosis Cognitive Impairment Diagnostic Test: ECAS-N Diagnostic Test: MoCA Diagnostic Test: CDR Other: Questionnaire

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


Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cognitive Impairment in ALS: Screening Tools, Experiences and Prognosis
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021


Group/Cohort Intervention/treatment
Persons with ALS
Persons With possible ALS-specific cognitive impairment will be tested With ECAS-N, MoCA, CDR and a questionnaire at 4 months (baseline) and 8 months (1. follow-up). Further evaluation will be with the questionnaire and CDR at each follow-up until 3 years or use of permanent ventilation support or Death. Information about use of advanced life-prolonging therapy will be collected from patient journal.
Diagnostic Test: ECAS-N
assessing ALS-specific cognitive impairment
Other Name: Edinburgh cognitive and behavioural ALS screen

Diagnostic Test: MoCA
assessing cognitive impairment
Other Name: Montreal cognitive assessment

Diagnostic Test: CDR
assessing global cognitive impairment, as well as possible diagnosis- and Level of dementia
Other Name: Clinical dementia rating

Other: Questionnaire
Questions related to work situation and car driving




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who fullfill the inclusion criteria and attending to the ALS-clinic at HUH within 4 months after being diagnosed with ALS.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03578796


Contacts
Contact: Tina Taule, PhD +47 41694143 tina.taule@helse-bergen.no

Locations
Norway
Haukeland University Hospital Recruiting
Bergen, Norway, 5021
Contact: Tina Taule, PhD    +47 41694143    tina.taule@helse-bergen.no   
Contact: Ole-Bjørn Tysnes, Professor       ole-bjorn.tysnes@helse-bergen.no   
Sponsors and Collaborators
Haukeland University Hospital
Western Norway University of Applied Sciences
Investigators
Principal Investigator: Tina Taule, PhD Haukeland University Hospital

Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT03578796     History of Changes
Other Study ID Numbers: 2016/2187-1
First Posted: July 6, 2018    Key Record Dates
Last Update Posted: July 6, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Haukeland University Hospital:
Amyotrophic Lateral Sclerosis
Cognitive
Predictor

Additional relevant MeSH terms:
Sclerosis
Cognitive Dysfunction
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Pathologic Processes
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases