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

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ClinicalTrials.gov Identifier: NCT03579017
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

Tracking Information
First Submitted Date June 1, 2018
First Posted Date July 6, 2018
Last Update Posted Date July 6, 2018
Actual Study Start Date May 1, 2017
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 5, 2018)
Edinburgh cognitive and behavioural 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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: July 5, 2018)
  • Montreal cognitive assessment (MoCA) - Norwegian version [ 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
  • Change from 4 months Edinburgh cognitive and behavioural 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Edinburgh Cognitive and Behavioural Amyotrophic Lateral Sclerosis Screen in Norway: A Validation Study
Official Title Cognitive Impairment in ALS: Screening Tools, Experiences and Prognosis
Brief Summary 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 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).
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population

Patients who fulfill the inclution criteria and attending to the ALS-unit at HUH, St.Olavs Hospital, Hospital of Southern Norway or Namsos Hospital, within 4 months after being diagnosed With ALS.

Healthy People and patients with dementia will constitute Control groups

Condition
  • Amyotrophic Lateral Sclerosis
  • Cognitive Impairment
Intervention
  • Diagnostic Test: ECAS-N
    All participants included will be tested with the ECAS-N
    Other Name: Edinburgh cognitive and behavioral ALS screen (Norwegian)
  • Diagnostic Test: MoCA
    All included patients With ALS will be tested With the MoCA
    Other Name: Montreal cognitive assessment (MoCA)
Study Groups/Cohorts
  • 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
    Interventions:
    • Diagnostic Test: ECAS-N
    • Diagnostic Test: MoCA
  • Healthy controls
    Persons with no cognitive impairment will be tested with the ECAS-N once, by one tester
    Intervention: Diagnostic Test: ECAS-N
  • Controls with dementia
    Persons with cognitive impairment due to other disorders will be tested with the ECAS-N once, by one tester
    Intervention: Diagnostic Test: ECAS-N
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 5, 2018)
50
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2021
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 35 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Tina Taule, PhD +47 41694143 tina.taule@helse-bergen.no
Contact: Tiina Rekand, professor tiina.rekand@helse-bergen.no
Listed Location Countries Norway
Removed Location Countries  
 
Administrative Information
NCT Number NCT03579017
Other Study ID Numbers 2016/3166
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Haukeland University Hospital
Study Sponsor Haukeland University Hospital
Collaborators Western Norway University of Applied Sciences
Investigators
Principal Investigator: Tina Taule, PhD Haukeland University Hospital
PRS Account Haukeland University Hospital
Verification Date April 2018