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

Active, not recruiting

• Conditions: Cognitive Impairment; Amyotrophic Lateral Sclerosis
• Interventions: Diagnostic Test: ECAS-N; Diagnostic Test: MoCA; Diagnostic Test: CDR; Other: Questionnaire

• Registration Number: NCT03578796
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2017-05-01
• Study First Submitted: 2018-06-01
• Study First Submitted QC: 2018-07-05
• Study First Posted: 2018-07-06
• Primary Completion: 2022-12-31
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-28
• Last Update Posted: 2024-10-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 31

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Persons with ALS	MoCA	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.
Persons with ALS	CDR	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.
Persons with ALS	ECAS-N	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.
Persons with ALS	Questionnaire	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.

Primary Outcome Measures

Name	Time	Method
Clinical Dementia Rating (CDR)	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

Name	Time	Method
Ability in car-driving	3 years or until death	We will use a categorical variable (yes or no) and time of change to reduced function.
Use of Advanced life-prolonging therapy	3 years or until death	We will use a categorical variable (yes or no) and time of change to reduced function.
Clinical Dementia Rating (CDR)	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.
Working ability	3 years or until death	We will use a categorical variable (yes or no) and time of change to reduced function.

Trial Locations

Locations (1)

Haukeland University Hospital; 🇳🇴 Bergen, Norway