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

Cognitive Impairment Clinical Trial

Official title:

Cognitive Impairment in ALS: Screening Tools, Experiences and Prognosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03578796
• Other study ID #: 2016/2187-1
• Status: Recruiting
• Start date: May 1, 2017
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2022
• Source: Haukeland University Hospital
• Contact: Tina Taule, PhD
• Phone: +47 41694143
• Email: tina.taule[@]helse-bergen.no
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Cognitive Dysfunction
• Cognitive Impairment
• Motor Neuron Disease
• Sclerosis

Intervention

Diagnostic Test:
• ECAS-N
assessing ALS-specific cognitive impairment
• MoCA
assessing cognitive impairment
• CDR
assessing global cognitive impairment, as well as possible diagnosis- and Level of dementia

Other:
• Questionnaire
Questions related to work situation and car driving

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen

Sponsors (2)

Lead Sponsor	Collaborator
Haukeland University Hospital	Western Norway University of Applied Sciences

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Edinburgh cognitive and behavioral amyotrophic lateral sclerosis screen-Norwegian Version (ECAS-N)	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.	4 months
Other	Change from 4 months Edinburgh cognitive and behavioral amyotrophic lateral sclerosis screen-Norwegian Version (ECAS-N) at 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.	8 months
Other	Montreal Cognitive Assessment (MoCA)	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 months
Other	Change from 4 months Montreal Cognitive Assessment (MoCA) at 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	8 months
Primary	Clinical Dementia Rating (CDR)	We will use the total CDR score (minimum score = 0, maximum score = 18). Low scores indicate less problems than high scores.	8 months
Secondary	Clinical Dementia Rating (CDR)	We will use the total CDR score (minimum score = 0, maximum score = 18). Low scores indicate less problems than high scores.	4 months
Secondary	Clinical Dementia Rating (CDR)	We will use the total CDR score (minimum score = 0, maximum score = 18). Low scores indicate less problems than high scores.	3 years or until death
Secondary	Ability in car-driving	We will use a categorical variable (yes or no) and time of change to reduced function.	8 months
Secondary	Ability in car-driving	We will use a categorical variable (yes or no) and time of change to reduced function.	4 months
Secondary	Ability in car-driving	We will use a categorical variable (yes or no) and time of change to reduced function.	3 years or until death
Secondary	Working ability	We will use a categorical variable (yes or no) and time of change to reduced function.	8 months
Secondary	Working ability	We will use a categorical variable (yes or no) and time of change to reduced function.	4 months
Secondary	Working ability	We will use a categorical variable (yes or no) and time of change to reduced function.	3 years or until death
Secondary	Use of Advanced life-prolonging therapy	We will use a categorical variable (yes or no) and time of change to reduced function.	8 months
Secondary	Use of Advanced life-prolonging therapy	We will use a categorical variable (yes or no) and time of change to reduced function.	4 months
Secondary	Use of Advanced life-prolonging therapy	We will use a categorical variable (yes or no) and time of change to reduced function.	3 years or until death