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

NCT ID: NCT03578796

Last Updated: 2024-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

31 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-01

Study Completion Date

2026-12-31

Brief Summary

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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

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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

Conditions

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Amyotrophic Lateral Sclerosis Cognitive Impairment

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

ECAS-N

Intervention Type DIAGNOSTIC_TEST

assessing ALS-specific cognitive impairment

MoCA

Intervention Type DIAGNOSTIC_TEST

assessing cognitive impairment

CDR

Intervention Type DIAGNOSTIC_TEST

assessing global cognitive impairment, as well as possible diagnosis- and Level of dementia

Questionnaire

Intervention Type OTHER

Questions related to work situation and car driving

Interventions

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ECAS-N

assessing ALS-specific cognitive impairment

Intervention Type DIAGNOSTIC_TEST

MoCA

assessing cognitive impairment

Intervention Type DIAGNOSTIC_TEST

CDR

assessing global cognitive impairment, as well as possible diagnosis- and Level of dementia

Intervention Type DIAGNOSTIC_TEST

Questionnaire

Questions related to work situation and car driving

Intervention Type OTHER

Other Intervention Names

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Edinburgh cognitive and behavioural ALS screen Montreal cognitive assessment Clinical dementia rating

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Western Norway University of Applied Sciences

OTHER

Sponsor Role collaborator

Haukeland University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tina Taule, PhD

Role: PRINCIPAL_INVESTIGATOR

Haukeland University Hospital

Locations

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Haukeland University Hospital

Bergen, , Norway

Site Status

Countries

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Norway

Other Identifiers

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2016/2187-1

Identifier Type: -

Identifier Source: org_study_id

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