Clinical trial NCT03578796: Edinburgh Cognitive and Behavioural Amyotrophic Lateral Sclerosis Screen in Norway: A Prospective Cohort Study
Official title: Cognitive Impairment in ALS: Screening Tools, Experiences and Prognosis
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Amyotrophic Lateral Sclerosis
Cognitive Impairment
Keywords: Amyotrophic Lateral Sclerosis
Cognitive
Predictor
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
Collaborators: name: Western Norway University of Applied Sciences
First posted: 2018-07-06
Enrollment: 31
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

Eligibility 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

Primary outcomes:
measure: Clinical Dementia Rating (CDR)
timeFrame: 8 months
Secondary outcomes:
measure: Clinical Dementia Rating (CDR)
timeFrame: 4 months
measure: Clinical Dementia Rating (CDR)
timeFrame: 3 years or until death
measure: Ability in car-driving
timeFrame: 8 months
measure: Ability in car-driving
timeFrame: 4 months
measure: Ability in car-driving
timeFrame: 3 years or until death
measure: Working ability
timeFrame: 8 months
measure: Working ability
timeFrame: 4 months
measure: Working ability
timeFrame: 3 years or until death
measure: Use of Advanced life-prolonging therapy
timeFrame: 8 months
measure: Use of Advanced life-prolonging therapy
timeFrame: 4 months
measure: Use of Advanced life-prolonging therapy
timeFrame: 3 years or until death
Other outcomes:
measure: Edinburgh cognitive and behavioral amyotrophic lateral sclerosis screen-Norwegian Version (ECAS-N)
timeFrame: 4 months
measure: Change from 4 months Edinburgh cognitive and behavioral amyotrophic lateral sclerosis screen-Norwegian Version (ECAS-N) at 8 months
timeFrame: 8 months
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: 4 months
measure: Change from 4 months Montreal Cognitive Assessment (MoCA) at 8 months
timeFrame: 8 months
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
Study officials:
affiliation: Haukeland University Hospital
name: Tina Taule, PhD
role: PRINCIPAL_INVESTIGATOR
References: