Amyotrophic Lateral Sclerosis, Cognitive Impairment
Conditions
Keywords
Amyotrophic Lateral Sclerosis, Cognitive, Predictor
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
Interventions
Sponsors
Western Norway University of Applied Sciences
Haukeland University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Clinical Dementia Rating (CDR) | 4 months | We will use the total CDR score (minimum score = 0, maximum score = 18). Low scores indicate less problems than high scores. |
| Ability in car-driving | 8 months | We will use a categorical variable (yes or no) and time of change to reduced function. |
| Working ability | 8 months | We will use a categorical variable (yes or no) and time of change to reduced function. |
| Use of Advanced life-prolonging therapy | 8 months | We will use a categorical variable (yes or no) and time of change to reduced function. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change from 4 months Edinburgh cognitive and behavioral amyotrophic lateral sclerosis screen-Norwegian Version (ECAS-N) at 8 months | 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. |
| Montreal Cognitive Assessment (MoCA) | 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 Montreal Cognitive Assessment (MoCA) at 8 months | 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 |
| Edinburgh cognitive and behavioral amyotrophic lateral sclerosis screen-Norwegian Version (ECAS-N) | 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. |
Countries
Norway
Outcome results
None listed